Valid Presafe Certificates

Here you will find the list of companies certified by Presafe Denmark A/S according to DS/EN ISO 13485:2003, 13485:2012, DS/EN ISO 9001:2000 and DS/EN ISO 9001:2008 standards.


Company Standard  Scope  Certificate  Expire date 

Adept Water Technologies A/S
Ellekær 6
2730 Herlev
Denmark

13485:2012 Design, development and production of active devices for disinfection of process water in dental unit water lines DGM-826 2019-03-16

Alpine Biomed ApS
Tonsbakken 16-18
2740 Skovlunde
Denmark

13485:2003 Design, development, production and servicing of computer aided diagnostic and therapeutic devices for neurology including related accessories DGM-602 2019-03-31

Ambi Pack BV
Het Tasveld 8
3345 GT Hendrik-Ido-Ambacht
The Netherlands

13485:2012 Mixing, tableting, capsulating and packing of oral and topical administered products registered as medical devices DGM-816 2019-03-31

ApodanNordic A/S
Lyngsø Allé 3
2970 Hørsholm
Denmark

13485:2012 Manufacture and sales of wound care, hygiene- and disinfection products and related accessories to medical devices. Sales and service of compression systems DGM-815 2019-02-28
ArcRoyal Ltd.
Virginia Road
Kells, Ci. Meath
ireland
9001:2008 + 13485:2012 Design and manufacture of sterile and non-sterile single use customized medical devices DGM-668 2018-09-15

Atonomics A/S
Borupvang 3
2750 Ballerup
Denmark

13485:2012 The manufacture and sales of in-vitro diagnostic analyzers and in-vitro diagnostic reagents used in the detection of lipids and HbA1C DGM-874 2019-03-16

Audmet B.V.
Kuiperij 5
1185 XS Amstelveen
Nederland

9001:2008 Service and sales of audiological solutions for better hearing DGM-644 2018-04-27
Bernafon AG
Morgenstrasse 131
3018 Bern
Switzerland
9001:2008
and
13485:2012
Development, Production, Marketing, Sales and Service of Hearing Solutions for Hearing Impaired DGM-650 2018-09-15
Bernafon Hörgererâte GmbH
Nunsdorfer Ring 14
12277 Berlin
Germany
9001:2008 + AC:2009 Distribution and servicing of BTE hearing aids, production, distributuon and serviceing of ITE hearing aids and production and distribution of ear molds DGM-434 2019-01-19

Bernafon, LLC
580 Howard Avenue
Somerset, NJ 08873
USA

13485:2012 Manufacture, sales,  distribution and servicing of air conduction hearing aids and faceplates including accessories and programming systems DGM-805 2019-03-31
BioTelemetry Technology ApS
Venblighedsvej 4
2970 Hørsholm
Denmark
13485:2012 Design, development, manufacture and sales of medical devices for monitoring, measuring and recording vital and non-vital physiological parameters DGM-888 2018-12-21
BK Medical ApS
Mileparken 34
2730 Herlev
Denmark
9001:2008, 13485:2003 and 13485:2012 Design, development, manufacturing and service of medical ultrasound devices DGM-539 2018-03-16
Chundsell Medicals AB
Insustrivägen 19
171 48 Solna
Sweden
13485:2012 Manufacture of IVD reagents and software tools for the evaluation of patients diagnosed with prostate cancer DGM-890 2019-07-01
Cimpax ApS
Lille Pilevang 4
3550 Slangerup
Denmark
13485:2012 Design, manufacture and distribution of instruments and accessories for laparoscopy, electrosurgery, and for delivery of anaesthetics DGM-681 2019-03-31

Codan Medical Aps
Færgevej 4
4970 Rødby
Denmark

13485:2003 + AC1:2007 Design, development and production of syringes. Ethylene oxide sterilization according to DS/EN ISO 11135-1  DGM-567 2018-05-20

Coloplast A/S
Holtedam 1
3050 Humlebæk
Denmark

ISO9001:2008, DS/EN ISO 9001:2008, DS/EN ISO 13485:2012
and ISO
13485:2003

Design and manufacturing of stents, implant, irrigation and drainage devices, catheters, penile prosthesis, testicular prosthesis, surgical meshes, intravesical needles, surgical instruments, anal plugs, externalcatheters and urine bags, ostomy appliances, wound dressings, skin care products for the areas of surgery, urology, gynecology and continence care, ostomy care, wound and skin care

DGM-639 2018-09-15

Coloplast A/S
Holtedam 3
3050 Humlebæk
Denmark 

ISO9001:2008, DS/EN ISO 9001:2008, DS/EN ISO 13485:2012 and ISO 13485:2003

Design and manufacturing of stents, implant, irrigation and drainage devices, catheters, penile prosthesis, testicular prosthesis, surgical meshes, intravesical needles, surgical instruments, anal plugs, externalcatheters and urine bags, ostomy appliances, wound dressings, skin care products for the areas of surgery, urology, gynecology and continence care, ostomy care, wound and skin care

DGM-639 2018-09-15
Coloplast A/S
Aa. Louis-Hansens Allé 15
3060 Espergærde
Denmark
ISO9001:2008, DS/EN ISO 9001:2008, DSEN/ISO 13485:2012
and ISO
13485:2003
Design and manufacturing of stents, implants, irrigation and drainage devices, catheters, penile prosthesis, testicular prosthesis, surgical meshes, intravesical needles, surgical instruments, anal plugs, external catheters and urine bags, ostomy appliances, wound dressings, skin care products and accessories for the areas of surgery, urology, gynecology and continence care, ostomy care, wound and skin care DGM-639 2018-09-15
Coloplast A/S
Industrivej 7
7700 Thisted
Denmark
ISO9001:2008, DS/EN ISO 9001:2008, DS/EN ISO 13485:2012
and ISO
13485:2003
Design and manufacturing of stents, implants, irrigation and drainage devices, catheters, penile prosthesis, testicular prosthesis, surgical meshes, intravesical needles, surgical instruments, anal plugs, external catheters and urine bags, ostomy appliances, wound dressings, skin care products and accessories for the areas of surgery, urology gynecology and continence care, ostomy care, wound and skin care DGM-639 2018-09-15
Coloplast A/S
Oldenvej 4
3490 Kvistgård
Denmark
ISO9001:2008, DS/EN ISO 9001:2008, DS/EN ISO 13485:2012
and ISO
13485:2003
Design and manufacturing of stents, implants, irrigation and drainage devices, catheters, penile prosthesis, testicular prosthesis, surgical meshes, intravesical needles, surgical instruments, anal plugs, external catheters and urine bags, ostomy appliances, wound dressings, skin care products and accessories for the areas of surgery, urology, gynecology and continence care, ostomy care, wound and skin care DGM-639 2018-09-15
Coloplast AB
Energigatan 21
434 37 Kungsbacka
Sweden
ISO9001:2008, DS/EN ISO 9001:2008, DS/EN ISO 13485:2012 and ISO 13485:2003 Design and manufacturing of stents, implants, irrigation and drainage devices, catheters, penile prosthesis, testicular prosthesis, surgical meshes, intravesical needles, surgical instruments, anal plugs, external catheters and urine bags, ostomy appliances, wound dressings, skin care products and accessories for the areas of surgery, urology, gynecology and continence care, ostomy care, wound and skin care DGM-639 2018-09-15
Coloplast GmbH
Kuehnstrasse 75
22045 Hamburg
Germany
9001:2008 and 13485:2003 Manufacturing, sale and distribution of medical devices. In addition patient counseling and patient care services related to the supply of medical devices products. DGM-651 2018-09-15
Coloplast Hungary KFT
Baraina Street 1
2890 Tata
Hungary
ISO9001:2008, DS/EN ISO 9001:2008, DS/EN ISO 13485:2012
and ISO
13485:2003
Design and manufacturing of stents, implants, irrigation and drainage devices, catheters, penile prosthesis, testicular prosthesis, surgical meshes, intravesical needles, surgical instruments, anal plugs, external catheters and urine bags, ostomy appliances, wound dressings, skin care products and accessories for the areas of surgery, urology gynecology and continence care, ostomy care, wound and skin care DGM-639 2018-09-15
Coloplast Hungary KFT 
Búzavirág út 15
2800 Tatabánya
Hungary
ISO9001:2008, DS/EN ISO 9001:2008, DS/EN ISO 13485:2012
and ISO
13485:2003
Design and manufacturing of stents, implants, irrigation and drainage devices, catheters, penile prosthesis, testicular prosthesis, surgical meshes, intravesical needles, surgical instruments, anal plugs, external catheters and urine bags, ostomy appliances, wound dressings, skin care products and accessories for the areas of surgery, urology, gynecology and continence care, ostomy care, wound and skin care DGM-639 2018-09-15
Coloplast Hungary KFT
Coloplast utca 2
4300 Nyírbátor
Hungary
ISO9001:2008, DS/EN ISO 9001:2008, DS/EN ISO 13485:2012
and ISO
13485:2003
Design and manufacturing of stents, implants, irrigation and drainage devices, catheters, penile prosthesis, testicular prosthesis, surgical meshes, intravesical needles, surgical instruments, anal plugs, external catheters and urine bags, ostomy appliances, wound dressings, skin care products and accessories for the areas of surgery, urology, gynecology and continence care, ostomy care, wound and skin care DGM-639 2018-09-15
Coloplast Hungary KFT
Coloplast utca 3
4300 Nyírbátor
Hungary
ISO9001:2008, DS/EN ISO 9001:2008, DS/EN ISO 13485:2012
and ISO
13485:2003
Design and manufacturing of stents, implants, irrigation and drainage devices, catheters, penile prosthesis, testicular prosthesis, surgical meshes, intravesical needles, surgical instruments, anal plugs, external catheters and urine bags, ostomy appliances, wound dressings, skin care products and accessories for the areas of surgery, urology, gynecology and continence care, ostomy care, wound and skin care DGM-639 2018-09-15
Coloplast Hungary KFT
Kerék utca 4
2800 Tatabánya
Hungary
ISO9001:2008, DS/EN ISO 9001:2008, DS/EN ISO 13485:2012 and ISO 13485:2003 Design and manufacturing of stents, implants, irrigation and drainage devices, catheters, penile prosthesis, testicular prosthesis, surgical meshes, intravesical needles, surgical instruments, anal plugs, external catheters and urine bags, ostomy appliances, wound dressings, skin care products and accessories for the areas of surgery, urology, gynecology and continence care, ostomy care, wound and skin care DGM-639 2018-09-15
Coloplast (China) Ltd.
No. 202, Baocheng Rd. Xiangzhou District
Zhuhai 519030
China
ISO9001:2008, DS/EN ISO 9001:2008, DS/EN ISO 13485:2012
and ISO
13485:2003
Design and manufacturing of stents, implants, irrigation and drainage devices, catheters, penile prosthesis, testicular prosthesis, surgical meshes, intravesical needles, surgical instruments, anal plugs, external catheters and urine bags, ostomy appliances, wound dressings, skin care products and accessories for the areas of surgery, urology, gynecology and continence care, ostomy care, wound and skin care DGM-639 2018-09-15

Coloplast (China) Ltd.
No. 18 Pingbei Er Rd.
Nanping Industrial Park
Zhuhai City 519060
China

ISO9001:2008, DS/EN ISO 9001:2008, DS/EN ISO 13485:2012
and ISO
13485:2003
Design and manufacturing of stents, implants, irrigation and drainage devices, catheters, penile prosthesis, testicular prosthesis, surgical meshes, intravesical needles, surgical instruments, anal plugs, external catheters and urine bags, ostomy appliances, wound dressings, skin care products and accessories for the areas of surgery, urology, gynecology and continence care, ostomy care, wound and skin care DGM-639 2018-09-15
Coloplast Corporation
1601 West River Road North
Minneapolist, MN 55411
USA
ISO9001:2008, DS/EN ISO 9001:2008, DS/EN ISO 13485:2012
and ISO
13485:2003
Design and manufacturing of stents, implants irrigation and drainage devices, catheters, penile prosthesis, testicular prosthesis, surgical meshes, intravesical needles, surgical instruments, anal plugs, external catheters and urine bags, ostomy appliances, wound dressings, skin care products and accessories for the areas of surgery, urology, gynecology and continence care, ostomy care, wound and skin care DGM-639 2018-09-15
Coloplast Manufacturing US, LLC
1940 Commerce Dr.
North Mankato, MN 56003
USA
ISO9001:2008, DS/EN ISO 9001:2008, DS/EN ISO 13485:2012
and ISO
13485:2003
Design and manufacturing of stents, implants, irrigation and drainage devices, catheters, penile prosthesis, testicular prosthesis, surgical meshes, intravesical needles, surgical instruments, anal plugs, external catheters and urine bags, ostomy appliances, wound dressings, skin care products and accessories for the areas of surgery, urology, gynecology and continence care, ostomy care, wound and skin care DGM-639 2018-09-15
Coloplast Manufacturing US. LLC
1601 West River Road North
Minneapolis, MN 55411
USA
ISO9001:2008, DS/EN ISO 9001:2008, DS/EN ISO 13485:2012
and ISO
13485:2003
Design and manufacturing of stents, implants, irrigation and drainage devices, catheters, penile prosthesis, testicular prosthesis, surgical meshes, intravesical needles, surgical instruments, anal plugs, external catheters and urine bags, ostomy appliances, wound dressings, skin care products and accessories for the areas of surgery, urology, gynecology and continence care, ostomy care, wound and skin care DGM-639 2018-09-15
Coloplast Manufacturing US, LLC
475 Riverside Pkwy.
Suite 400 Lithia Springs,
GA 30122
USA
ISO9001:2008, DS/EN ISO 9001:2008, DS/EN ISO 13485:2012
and ISO
13485:2003
Design and manufacturing of stents, implants, irrigation and drainage devices, catheters, penile prosthesis, testicular prosthesis, surgical meshes, intravesical needles, surgical instruments, anal plugs, external catheters and urine bags, ostomy appliances, wound dressings, skin care products and accessories for the areas of surgery, urology, gynecology and continence care, ostomy care, wound and skin care DGM-639 2018-09-15
Coloplast Distribution GmbH 
Werner-Schröder-Strasse 1
21035 Hamburg
Germany
ISO9001:2008, DS/EN ISO 9001:2008, DS/EN ISO 13485:2012
and ISO
13485:2003
Design and manufacturing of stents, implants, irrigation and drainage devices, catheters, penile prosthesis, testicular prosthesis, surgical meshes, intravesical needles, surgical instruments, anal plugs, external catheters and urine bags, ostomy appliances, wound dressings, skin care products and accessories for the areas of surgery, urology, gynecology and continence care, ostomy care, wound and skin care DGM-639 2018-09-15
Coloplast Ltd
Orton Southgate
Peterborough PE2 6BJ
United Kingdom
ISO9001:2008, DS/EN ISO 9001:2008, DS/EN ISO 13485:2012 and ISO 13485:2003 Design and manufacturing of stents, implants, irrigation and drainage devices, catheters, penile prosthesis, testicular prosthesis, surgical meshes, intravesical needles, surgical instruments, anal plugs, external catheters and urine bags, ostomy appliances, wound dressings, skin care products and accessories for the areas of surgery, urology, gynecology and continence care, ostomy care, wound and skin care DGM-639 2018-09-15
Coloplast Manufacturing France S.A.S.
Le Pontet, BP89
24203 Sarlat Cedex
France
ISO9001:2008, DS/EN ISO 9001:2008, DS/EN ISO 13485:2012
and ISO
13485:2003

Design and manufacturing of stents, implants, irrigation and drainage devices, catheters, penile prosthesis, testicular prosthesis, surgical meshes, intravesical needles, surgical instruments, anal plugs, external catheters and urine bags, ostomy appliances, wound dressings, skin care products and accessories for the areas of surgery, urology, gynecology and continence care, ostomy care, wound and skin care

DGM-639 2018-09-15
Coloplast Manufacturing France SAS
Lieduit La Boursidière
Centre d'Affaires
92350 Le Plessis Robinson
France
ISO9001:2008, DS/EN ISO 9001:2008, DS/EN ISO 13485:2012
and ISO
13485:2003
Design and manufacturing of stents, implants, irrigation and drainage devices, catheters, penile prosthesis, testicular prosthesis, surcigal meshes, intravesical needles, surgical instruments, anal plugs, external catheters and urine bags, ostomy appliances, wound dressings, skin care products and accesssories for the areas of surgery, urology, gynecology and continence care DGM-639 2018-09-15
Coloplast Manufacturing France SAS
Madrazès, BP89
24203 Sarlet Cedex
France
ISO9001:2008, DS/EN ISO 9001:2008, DS/EN ISO 13485:2012
and ISO
13485:2003
Design and manufacturing of stents, implants, irrigation and drainage devices, catheters, penile prosthesis, testicular prosthesis, surgical meshes, intravesical needles, surgical instruments, anal plugs, external catheters and urine bags, ostomy appliances, wound dressings, skin care products and accesssories for the areas of surgery, urology, gynecology and continence care DGM-639 2018-09-15
Coloplast Manufacturing France SAS
ZAC du Clotais
2b, Route du Chemin Blanc
91160 Champlan
France
ISO9001:2008, DS/EN ISO 9001:2008, DS/EN ISO 13485:2012
and ISO
13485:2003
Design and manufacturing of stents, irrigation, implants and drainage devices, catheters, penile prosthesis, testicular prosthesis, surgical instruments, anal plugs, external catheters and urine bags, ostomy appliances, wound dressings, skin care products and accesssories for the areas of surgery, urology, gynecology and continence care DGM-639 2018-09-15
Coloplast Productos Medicos SA Ruiseñor 15 Polígono los Gallegos 28946 Fuenlabrada Spain ISO9001:2008, DS/EN ISO 9001:2008, DS/EN ISO 13485:2012 and ISO 13485:2003 Design and manufacturing of stents, irrigation, implants and drainage devices, catheters, penile prosthesis, testicular prosthesis, surgical instruments, anal plugs, external catheters and urine bags, ostomy appliances, wound dressings, skin care products and accesssories for the areas of surgery, urology, gynecology and continence care DGM-639 2018-09-15

Coloplast S.p.A
Via del Commercio Associato 15 40127 Bologna
Italy

ISO9001:2008, DS/EN ISO 9001:2008, DS/EN ISO 13485:2012 and ISO 13485:2003 Design and manufacturing of stents, irrigation, implants and drainage devices, catheters, penile prosthesis, testicular prosthesis, surgical instruments, anal plugs, external catheters and urine bags, ostomy appliances, wound dressings, skin care products and accesssories for the areas of surgery, urology, gynecology and continence care DGM-639 2018-09-15
Continence Care ApS
Dybendalsvænget 4
2630 Taastrup
Denmark
13485:2003 Manufacture of sterile urology and airway's catheters, endotracheal, tracheostomy and gastrological tubes, oxygen and laryngial masks, nasal oxygen cannula, urine drainage bags, rectal catheters and urimeters  DGM-593 2018-03-25
Contura International A/S 
Sydmarken 23
2860 Søborg
Denmark
13485:2016 Design, development and manufacture of implantable hydrogel products. Design, development and manufacture of urethral bulking procedure packs. Design, development and manufacture of guidance devices intended to be used with implantable hydrogel products. DGM-560 2020-09-01
Cortex Technology ApS 
Plastvænget 9
9560 Hadsund
Denmark
13485:2012 Manufacture, testing and service of cryosurgical units
and cryosurgical accessories 
DGM-610 2018-10-02
Covidien IIc 
15 Hampshire Street
Mansfield, MA 02048
USA
13485:2003 Design, manufacturing, service and distribution of RF Surgical Devices, catheters and related accessories for gastrological and esophageal ablation, Endoscopic Ultrasound Needle Aspiration System and sample collection devices. DGM-789 2018-07-02
DDD-Diagnostic A/S
Dr. Neergaards Vej 5E
2970 Hørsholm
13485:2003 Design, development, production, installation and servicing of gamma cameras DGM-509 2018-02-10

DeRoyal Industries, Inc.
200 DeBusk Lane
Powell, TN 37849
USA 

13485:2003 The design and manufacture of injection molded products for the medical device industry DGM-817 2019-03-31

DNA Diagnostic A/S
Voldbjergvej 14
8240 Risskov
Denmark

9001:2008 Production and Sale of Molecular Diagnostic Kit DGM-828 2018-09-15

DNA Diagnostic A/S
Voldbjergvej 14
8240 Risskov
Denmark

13485:2012 Production and Sale of Molecular Diagnostic Kit DGM-829 2019-03-31
Ellipse A/S
Agern Allé 11
2970 Hørsholm
Denmark
9001:2008
and
13485:2003 + AC:2007
Development, design, production and service of IPL and Laser equipment for medical treatment DGM-459 2018-05-29
Eldon Biological A/S
Sandtoften 10
2820 Gentofte
Denmark
13485:2012 Manufacture and final testing of dry format cards and assembly of kits for in vitro diagnostic blood type determination DGM-692 2019-03-31
Elltec Ltd.
Shirakawa No. 6, Co., Building
2-18-15, Nishiki Naka-ku
460 0003 Nagoya
Japan
13485:2012 Design, development, production and servicing of blood warmers DGM-559 2018-12-18

Fast Plast
Vilhelmsborgvej 2
7700 Thisted
Denmark

 9001:2008  Manufacture and sale of plastic disposables for tableware and plastic packaging to the medicine and food industry  DGM-838  2018-12-22
FH Service
Falen 18B
5000 Odense C
Denmark
13485:2012 Production and servicing of therapeutic muscle stimulators DGM-867 2018-08-12
Ferrosan Medical Devices A/S
Sydmarken 5
2860 Søborg
13485:2012 Design, manufacture and final testing of absorbable gelatin products for haemostatic use DGM-709 2019-03-31
Formteknik IM A/S
Vestre Hedevej 16
4000 Roskilde
Denmark
13485:2012 Initial Production of injection moulded parts for the medical device industry DGM-901 2019-03-31

Grouleff-DK ApS
Korshøjvej 2A, Virklund
8600 Silkeborg
Denmark

13485:2012 Production of customer specific examination tables DGM-834 2019-03-31
Heka Dental A/S
Baldershøj 38
2635 Ishøj
13485:2012 Production, test and service of dental units and dental chairs DGM-898 2019-03-31
Herlev Hospital
Substratafdelingen ved Klinisk
Mikrobiologisk Afdeling
Herlev Ringvej 75
2730 Herlev
Denmark
9001:2008
and
13485:2012
Udvikling, produktion og salg af dyrkningsmedier til mikrobiologisk diagnostik DGM-648 2018-11-18

Haukeland Universitetssykehus Avdeling for immunologi og transfusjonsmedisin, Helse Bergen
Jonas Lies Vei 65
5021 Bergen
Norge

13485:2012 Fremstilling og endelig kontrol af røde blodceller og serum/plasma produkter til in vitro-diagnostik blodtypebestemmelse DGM-807 2018-07-30
Inmedico A/SJohann
Johan Gutenbergs Vej 3
8200 Aarhus N
Denmark
13485:2012 Production and serivicing of audiometers and tympanometers  DGM-540 2018-08-28
Innovison ApS
Skovvænget 2
5620 Glamsberg
Denmark
13485:2012 Design, production and servicing of cardiopulmonary function test equipment  DGM-864  2018-07-06
Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086
USA
13485:2012 Design, manufacture, service and installation of computer-controlled surgical systems and instruments, including endoscopes, surgical instruments, sterile drapes and accessories for use with the computer-controlled systems. Design and manufacture of staples and stapling systems. DGM-552 2018-02-10
Intuitive Surgical, Inc.
950 Kifer Road
Sunnyvale, CA 94086
USA
13485:2012 Design, manufacture, service and installation of computer-controlled surgical systems and instruments, including endoscopes, surgical instruments, sterile drapes and accessories for use with the computer-controlled systems. Design and manufacture of staples and stapling systems. DGM-552 2018-02-10
Intuitive Surgical, Inc.
1450 Kifer Road
Sunnyvale, CA 94086
USA
13485:2012 Design, manufacture, service and installation of computer-controlled surgical systems and instruments, including endoscopes, surgical instruments, sterile drapes and accessories for use with the computer-controlled systems. Design and manufacture of staples and stapling systems. DGM-552 2018-02-10

Intuitive Surgical Inc.
1090 Kifer Road
Sunnyvale, CA 94086
USA

13485:2012 Design, manufacture, service and installation of computer-controlled surgical systems and instruments, including endoscopes, surgical instruments, sterile drapes and accessories for use with the computer-controlled systems. Design and manufacture of staples and stapling systems. DGM-552 2018-02-10

Intuitive Surgical Inc.
710 Venture Dr., Suite 300
DeSoto Trade Center Building 1
Southaven, MS 38672
USA

13485:2012 Design, manufacture, service and installation of computer-controlled surgical systems and instruments, including endoscopes, surgical instruments, sterile drapes and accessories for use with the computer-controlled systems. Design and manufacture of staples and stapling systems. DGM-552 2018-02-10
Intuitive Surgical S. de R.L. de C.V.
Circuito Internacional Sur #8
Parque Industrial Nelson
Carretera a San Luis R.C.
Km 14, Mexicali B.C.C.P. 21397
Mexico
13485:2012 Design, manufacture, service and installation of computer-controlled surgical systems and instruments, including endoscopes, surgical instruments, sterile drapes and accessories for use with the computer-controlled systems. Design and manufacture of staples and stapling systems.  DGM-552  2018-02-10

Intuitive Surgical S. de R.L. de C.V.
Circuito Internacional Sur #21-A
Parque Industrial Nelson
Carretera a San Luis R.C.
Km 14, Mexicali B.C.C.P. 21397
Mexico

13485:2012 Design, manufacture, service and installation of computer-controlled surgical systems and instruments, including endoscopes, surgical instruments, sterile drapes and accessories for use with the computer-controlled systems. Design and manufacture of staples and stapling systems. DGM-552 2018-02-10

Intuitive Surgical, Sárl
1 Chemin des Mûriers
1170 Aubonne
Switzerland

13485:2012 Design, manufacture, service and installation of computer-controlled surgical systems and instruments, including endoscopes, surgical instruments, sterile drapes and accessories for use with the computer-controlled systems. Design and manufacture of staples and stapling systems. DGM-552 2018-02-10

KEN HYGIENE SYSTEMS  A/S
Bøgebjergvej 60
5672 Broby
Denmark

13485:2012 Development and production of washer disinfectors in Denmark. Sales and service of washer disinfectors, ultrasonic cleaners and sterilizers  DGM-878  2019-03-31

KEN Hygiene Systems A/S
Göteborgvägen 74
433 63 Sävedalen
Sweden

13485:2012 Development and production of washer disinfectors in Denmark. Sales and service of washer disinfectors, ultrasonic cleaners and sterilizers  DGM-878 2019-03-31

KEN HYGIENE SYSTEMS  AS
Verseoer Furulunds Vei 21, Alnabru
0668 Oslo
Norge

 13485:2012  Development and production of washer disinfectors in Denmark. Sales and service of washer disinfectors, ultrasonic cleaners and sterilizers  DGM-878  2019-03-31

Kivex Biotec A/S
Klintehøj Vænge 3-5
3460 Birkerød
Denmark

13485:2012  Production, installation and servicing of IVF incubators and IVF work stations  DGM-825  2017-12-18
Knudsen Plast A/S
Industrivej 21
3300 Frederiksværk
Denmark
13485:2016 Contract design and development including development of injection moulds; production, assembly and sterile packaging of injection moulded plastic products for the medical device industry DGM-641 2020-06-28
Knudsen Plast s.r.o.
Herl'anska 547
Vranov nad Topl'ou
Slovakia
13485:2016 Contract design and development including development of injection moulds; production, assembly and sterile packaging of injection moulded plastic products for the medical device industry DGM-641 2020-06-28

Laboratoires Coloplast S.A.S
35 bvd de Courcerin
77185 Lognes
France

ISO9001:2008, DS/EN ISO 9001:2008, DS/EN ISO 13485:2012
and ISO
13485:2003
Design and manufacturing of stents, irrigation, implants and drainage devices, catheters, penile prosthesis, testicular prosthesis, surgical instruments, anal plugs, external catheters and urine bags, ostomy appliances, wound dressings, skin care products and accesssories for the areas of surgery, urology, gynecology and continence care DGM-639 2018-09-15
LBN Medical A/S
Gugvej 70
9210 Aalborg
13485:2012 Repair and refurbishment of used medical imaging equipment and storage thereof DGM-690 2018-12-18

MBH - International A/S
Gydevang 28-30
3450 Allerød
Denmark

13485:2012  Development and production of fecal irrigation systems. Production of urinary balloon catheters, hydrophilic urinary catheters, lubrication gel, urine bags with accessories, male external catheters and hydrocolloid bandages. DGM-631 2019-03-31

Medichanical Engineering ApS
Havneparken 2                                     7100 Vejle
Denmark

DS/EN ISO 9001:2008 and DS/EN ISO 13485:2012 Manufacturing of orthopedic surgical measuring devices for non-vital physological parameters in Class lm and Class lla DGM-860 2018-10-09

Medicologic A/S
Aren Jacobsens Allé 15-17
2300 Copenhagen S
Denmark

13485:2003

Contract Design and Development services related to consumables and disposable for the  Medical Device Industry and the In Vitro Diagnostic Device Industry

DGM-782 2018-05-13

Medicom Innovation Partner a/s
(Bang & Olufsen Medicom a/s)
Gimsinglundvej 20
7600 Struer
Denmark

13485:2012

Design, development and production of medical devices for dosage and administration of drugs and diagnostic systems

DGM-369 2019-03-31
Mermaid Medical A/S
Frydensbergvej 25
3660 Stenløse
Denmark
DS/EN ISO 13485:2016 Design, manufacture, sale and distribution of soft tissue biopsy needles, access needle for guidewire and drainage catheters. Sales and distribution of medical devices. DGM-769 2020-10-23
Nanovi A/S
Diplomvej 373N
2800 Lyngbu
Denmark
EN ISO 13485:2012 Design, manufacture and distributing of injectable liquid tissue marker DGM-880 2019-03-18
Nidacon International AB
Flöjesberggatan 16 B
431 37 Mölndal
Sweden
EN ISO 13485:2012 Design, development, manufacture, sales and marketing of medical devices for ART (Assisted Reproduction Technology) DGM-831 2018-08-18
Nrt, Nordisk Røntgen Teknik A/S
(NRT X-ray A/S)
Birkegårdsvej 16
8361 Hasselager
Denmark 
9001:2008
and
13485:2012
Design, development, production, installation and service of equipment for diagnostic  medical X-ray systems  DGM-534 2018-03-27
Nunc A/S
Kamstrupvej 90
4000 Roskilde
Denmark
(Thermo Fisher Scientific, Roskilde Site)
13485:2012 Design, development, manufacture, surface treatment, injection molding plastics, printing, assembly, sterilization by irradition and worldwide sales support of medical devices for storage, handling and transportation of medica for In Vitro Fertilization and diagnostic use. Sub-contract irradiation of customer products to customer specifications per ISO11137 DGM-770 2019-01-18
OpenTeleHealth ApS
Lysholt Allé 10
7100 Vejle
Denmark
DS/EN ISO 13485:2012 Design production and sale of tele medical software solutions DGM-875 2019-03-31
Organon Ireland
Drynam Road
Swords, Co. Dublin
Ireland
DS/EN ISO 13485:2012 Manufacture and final inspection of neuromuscular transmission monitors  DGM-544 2018-07-02
Organon N.V.
Klosterstraat 6
5349 AB, Oss
The Netherlands
13485:2012 Manufacture and final inspection of neuromuscular transmission monitors DGM-865 2018-09-07
ORIGIO a/s
Knardrupvej 2
2760 Målev
Denmark
9001:2008 and 13485:2003 Design, development, manufacture and aseptic processing including aseptic filtration, final testing and distribution of cell culture products for use in assisted reproductive technology (ART) procedures. Design, development, manufacture, final testing and distribution of storage devices, needles and catheters for use in assisted reproductive technology (ART) procedures. Manufacture, final testing, distribution and servicing of electronic devices for use in assisted reproductive technology (ART) procedures. DGM-510

2018-09-15

Oslo Universitetssykehus HF
Avdeling for immunologi og transfusjonsmedisin
Ullevål Sykehus
Kirkeveien 166
0407 Oslo
Norway
13485:2012 Fremstilling af røde blodceller og serum/plasma fra humane bloddonorer til in vitro-diagnostisk blodtypebestemmelse og antistoffscreening/identifisering DGM-775 2018-02-06

Oticon A/S
Kongebakken 9
2765 Smørum
Denmark
9001:2008
and
13485:2012
Development, production, sales and service of audiological solutions for better hearing DGM-640 2019-02-08
Oticon A/S
DGS Denmark A/S
Tempovej 15
2750 Ballerup
Denmark
9001:2008
and
13485:2012
Development, production, sales and service of audiological solutions for better hearing DGM-640 2019-02-08
Oticon A/S
DGS Denmark A/S
Tilstedvej 73
7700 Thisted
Denmark
9001:2008 and
13485:2012
Development, production, sales and service of audiological solutions for better hearing DGM-640 2019-02-09
Oticon A/S
DGS Poland Sp. zo. o.
ul. Lubieszynska 59 Mierzyn,
72-006 Szczecin
Poland
9001:2008
and
13485:2012
Development, production, sales and service of audiological solutions for better hearing DGM-640 2019-02-08
Oticon A/S
DGS Poland Sp. zo. o.
ul. Lubieszynska 42 Mierzyn,
72-006 Szczecin
Poland
9001:2008
and
13485:2012

Development, production, sales and service of audiological solutions for better hearing

DGM-640 2019-02-08

Oticon A/S
DGS Business Services Sp.z.o.o.
ul. Malczewskiego 26
71-612 Szczecin
Poland

9001:2008 and 13485:2012

Development, production, sales and service of audiological solutions for better hearing

DGM-640 2019-02-08

Oticon A/S (SBO Hearing A/S)
Kongebakken 9
2765 Smørum
Denmark

13485:2012

Development, production, sales and service of audiological solutions for better hearing

DGM-844 2019-02-08
Oy Medix Biochemica Ab
Klovinpellontie 3
02180 Espoo
Finland
13485:2016 The design and development, manufacture, distribution and service, of in-vitro diagnostic analyzers, in-vitro diagnostic test kits, controls and reagents used in diagnosis and screening of pregnancy, disease status, and endocrine disorders, including near patient in-vitro diagnostic devices DGM-543 2020-11-03
Plum A/S
Frederik Plums Vej 2
5610 Assens
Denmark
13485:2012 Manufacture of eye irrigation fluids for first aid and adhesive bandage. Sale of cleansing pads, cooling gel and wound dressings for first aid DGM-766 2018-11-13
PNN Medical A/S 
(Engineers & Doctors Wallsten Medical A/S)
Oldenvej 13
3490 Kvistgård
Denmark
13485:2003  + AC:2007 Development, design, production and final inspection of urological stents, urological stent systems, urological catheters, urological access systems and related accessories DGM-311 2018-09-07

Price Invena ApS
Kronprinsessegade 36, 2.sal
1306 København K
Denmark

DS/EN ISO 13485:2012 Manufacturing and testing of umbilical cord cutters.  DGM-854 2018-01-14
Medicopack A/S
Industrivej 6
5550 Langeskov
Denmark
13485:2016 Development, design, manufacture and distribution of bottles and containers for medical use and of mixing devices for infusion fluids DGM-656 2020-11-10
Medicopack A/S
Industrivej 6
5550 Langeskov
Denmark
9001:2008 Development, design, manufacture and distribution of bottles and containers for medical use and of mixing devices for infusion fluids DGM-902 2018-09-15
Royal Sterilization Systems
A disvision of DeRoyal Industries, Inc.1135 Highway 33 South
New Tazewell, 37825 TN
USA
13485:2003  Ethylene oxide sterilization of medical devices and laboratory services for chemistry, microbiology, sterility and media preparation  DGM-537 2018-01-30

Royal Sterilization Systems
A disvision of DeRoyal Industries, Inc.1135 Highway 33 South
New Tazewell, 37825 TN
USA

11135-1:2007

Ethylene oxide sterilization of medical devices

DGM-684

2018-01-30

Rønvig Dental Manufacturing A/S
Gl. Vejlevej 59
8261 Daugaard
Denmark
9001:2008 & 13485:2012 Development, production, servicing and marketing of dental products and electro-medical equipment DGM-841 2017-10-15
Sonic Innovations, Inc. 
580 Howard Avenue, Somerset
NJ 08873,
USA
9001:2008
and
13485:2003 + AC:2009
Design, development, production, and servicing of air conduction hearing aids and faceplates including accessories and programming systems DGM-472 2018-09-15
SP Medical A/S
Møllevej 1
4653 Karise
Denmark
9001:2008 and 13485:2012 Development and manufacture of Guide Wires. Construction, production, assembly and decoration of injection moulded plastic parts and metal parts DGM-728 2018-11-05
SSI Diagnostica A/S
Herredsvejen 2
3400 Hillerød
9001:2008 and 13485:2012 Udvikling, produktion og salg af in vitro-diagnostika og blodprodukter fra dyr  DGM-893 2018-09-15
Technolution A/S
Lyngsø Allé
2970 Hørsholm
Denmark
13485:2012 Design, development and prototyping of consumable and disposable IVD and non IVD medical devices, including risk management activities DGM-837 2019-03-31
Tonica Elektronik A/S 
Lucernermarken 15
3520 Farum
Denmark
13485:2012 Design, manufacture, testing and service of magnetic stimulation equipment, magnetic stimulation monitoring devices, therapeutic intense pulsed light equipment & anaesthetic gas mixing and monotoring systems  DGM-511 2018-06-26
Unitron Hearing Ltd.
20 Beasley Drive, P.O. Box 9017
Kitchener, ON N2G 4X1
Canada
13485:2003 Design, development, production and servicing of BTE hearing instrument systems, of ITE hearing instrument systems, of ITE hearing aid kits and of related accessories  DGM-812 2019-02-28
Unitron Hearing Ltd.
250 Trillium Drive
Kitchener, Ontario N2G 4X1
Canada
13485:2003 Design, development, production and servicing of BTE hearing instrument systems, of ITE hearing instrument systems, of ITE hearing aid kits and of related accessories  DGM-812 2019-02-28

Vigmed AB
Garnisonsgatan 10
254 66 Helsingborg
Sweden

13485:2012 and 9001:2008 Development and manufacturing of solutions for preventing needle stick injuries in healthcare e.g. IV-cannula, syreinges, prefilled syringes, insulin, blood collection needles and lancets DGM-840 2018-09-15

Vitrolife Sweden AB
Gustaf Werners Gata 2
421 32 V. Frölunda
Sweden

13485:2003 Development, manufacture and marketing of products and systems for preparation, cultivation and storage of cells, intended for therapy DGM-845 2018-02-20

Vitrolife A/S
Jens Juuls Vej 20
8260 Viby J
Denmark

13485:2012 Production, installation and servicing of IVF incubators and IVF related accessories DGM-672 2018-06-26