Valid Presafe Certificates

Here you will find the list of companies certified by Presafe Denmark A/S according to DS/EN 13485:2016, DS/EN ISO 9001:2015 standards.


Company Standard  Scope  Certificate  Expire date 

Actim OY
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-928 2020-11-03

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

13485:2016 Mixing, tableting, capsulating and packing of oral and topical administered products registered as medical devices DGM-816 2020-06-23

ApodanNordic A/S
Lyngsø Allé 3
2970 Hørsholm
Denmark

13485:2016 Manufacture and sales of wound care, hygiene- and disinfection products and related accessories to medical devices. Sales and service of compression systems DGM-815 2022-02-28
ArcRoyal Ltd.
Virginia Road
Kells, Ci. Meath
ireland
13485:2016 Design and manufacture of sterile and non-sterile single use customized medical devices DGM-668 2020-04-28
Bernafon AG
Morgenstrasse 131
3018 Bern
Switzerland
13485:2016 Development, production, marketing, sales and service of audiological solutions for better hearing DGM-650 2021-09-27
BK Medical ApS
Mileparken 34
2730 Herlev
Denmark
13485:2016 Design, development, manufacturing and service of medical ultrasound devices DGM-539 2021-03-16
Chundsell Medicals AB
Insustrivägen 19
171 48 Solna
Sweden
13485:2016 Manufacture of IVD reagents and software tools for the evaluation of patients diagnosed with prostate cancer DGM-890 2022-03-27
Cimpax ApS
Lille Pilevang 4
3550 Slangerup
Denmark
13485:2016 Design, manufacture and distribution of instruments and accessories for laparoscopy, of instruments and accessories for electrosurgery, and of catheters and accessories for delivery of anesthetics DGM-681 2019-11-18

Codan Medical Aps
Færgevej 4
4970 Rødby
Denmark

13485:2016 Design, development and production of syringes. Ethylene oxide sterilization according to DS/EN ISO 11135-1:2017  DGM-567 2022-02-28

Coloplast A/S
Holtedam 1
3050 Humlebæk
Denmark

ISO 9001:2015, ISO 13485:2016

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 2021-09-12

Coloplast A/S
Holtedam 3
3050 Humlebæk
Denmark 

ISO 9001:2015, ISO 13485:2016

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 2021-09-12
Coloplast A/S
Aa. Louis-Hansens Allé 15
3060 Espergærde
Denmark
ISO 9001:2015, ISO 13485:2016
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 2021-09-12
Coloplast A/S
Oldenvej 4
3490 Kvistgård
Denmark
ISO 9001:2015, ISO 13485:2016
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 2021-09-12
Coloplast AB
Energigatan 21
434 37 Kungsbacka
Sweden
ISO 9001:2015, ISO 13485:2016
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 2021-09-12
Coloplast GmbH
Kuehnstrasse 75
22045 Hamburg
Germany
13485:2016 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 2020-06-06
Coloplast Hungary KFT 
Búzavirág út 15
2800 Tatabánya
Hungary
ISO 9001:2015, ISO 13485:2016
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 2021-09-12
Coloplast Hungary KFT
Coloplast utca 2
4300 Nyírbátor
Hungary
ISO 9001:2015, ISO 13485:2016
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 2021-09-12
Coloplast Hungary KFT
Coloplast utca 3
4300 Nyírbátor
Hungary
ISO 9001:2015, ISO 13485:2016
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 2021-09-12
Coloplast Hungary KFT
Kerék utca 4
2800 Tatabánya
Hungary
ISO 9001:2015, ISO 13485:2016 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 2021-09-12
Coloplast (China) Ltd.
No. 202, Baocheng Rd. Xiangzhou District
Zhuhai 519030
China
ISO 9001:2015, ISO 13485:2016
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 2021-09-12

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

ISO 9001:2015, ISO 13485:2016
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 2021-09-12
Coloplast Corporation
1601 West River Road North
Minneapolist, MN 55411
USA
ISO 9001:2015, ISO 13485:2016
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 2021-09-12
Coloplast Manufacturing US, LLC
1940 Commerce Dr.
North Mankato, MN 56003
USA
ISO 9001:2015, ISO 13485:2016
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 2021-09-12
Coloplast Manufacturing US. LLC
1601 West River Road North
Minneapolis, MN 55411
USA
ISO 9001:2015, ISO 13485:2016
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 2021-09-12
Coloplast Manufacturing US, LLC
475 Riverside Pkwy.
Suite 400 Lithia Springs,
GA 30122
USA
ISO 9001:2015, ISO 13485:2016
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 2021-09-12
Coloplast Distribution GmbH 
Werner-Schröder-Strasse 1
21035 Hamburg
Germany
ISO 9001:2015, ISO 13485:2016
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 2021-09-12
Coloplast Ltd
Orton Southgate
Peterborough PE2 6BJ
United Kingdom
ISO 9001:2015, ISO 13485:2016 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 2021-09-12
Coloplast Manufacturing France S.A.S.
Le Pontet, BP89
24203 Sarlat Cedex
France
ISO 9001:2015, ISO 13485:2016

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 2021-09-12
Coloplast Manufacturing France SAS
Lieduit La Boursidière
Centre d'Affaires
92350 Le Plessis Robinson
France
ISO 9001:2015, ISO 13485:2016
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 2021-09-12
Coloplast Manufacturing France SAS
Madrazès, BP89
24203 Sarlet Cedex
France
ISO 9001:2015, ISO 13485:2016
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 2021-09-12
Coloplast Manufacturing France SAS
ZAC du Clotais
2b, Route du Chemin Blanc
91160 Champlan
France
ISO 9001:2015, ISO 13485:2016
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 2021-09-12
Coloplast Productos Medicos 

Arroyo de los Prados 5
Poligono Industrial las Arenas
28320 PINTO, Madrid
Spain
ISO 9001:2015, ISO 13485:2016 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 2021-09-12

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

ISO 9001:2015, ISO 13485:2016 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 2021-09-12

Coloplast Volume Mfg. Costa Rica SA
Calle 58, Zona Franca La Lima
La Lima
Guadalupe
30106 CartagoCosta Rica

ISO 9001:2015, ISO 13485:2016 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 2021-09-12
Continence Care ApS
Islevsdalvej 184
2610 Rødovre
Denmark
13485:2016 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 2021-03-23
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
13485:2016 Manufacture, testing and service of cryosurgical units
and cryosurgical accessories 
DGM-610 2021-10-01
Covidien IIc 
15 Hampshire Street
Mansfield, MA 02048
USA
13485:2016 Design, manufacturing and service of RF Surgical Devices, catheters and related accessories for gastrological and esophageal ablation, endoscopic ultrasound needle aspiration system and sample collection devices.

Design and manufacturing of electrosurgical vessel sealing systems and associated accessories.

Manufacturing of microwave ablation generator, associated accessories and electromagnetic navigation accessories.
DGM-789 2021-07-02
DDD-Diagnostic A/S
Kærvej 12
2970 Hørsholm
Denmark
13485:2016 Design, development, production, installation and servicing of gamma cameras DGM-509 2021-02-09

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

13485:2016 The design and manufacture of injection molded products for the medical device industry DGM-817 2020-03-06

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

13485:2016 Design, manufacture and distribution of Scalpels, Cautery pencils and blades, Surgical Sponges and dressings, Surgical Gauze Packing, Bandages, Surgical specimen Pouches, surgical Vessel Loops, surgical eye spears, Vaginal and Perineal packing for surgery, surgical insufflation filters and tubing, Pneumoperitoneum Needles, Surgical procedure trays. Design, manufacture and distribution of Wound Care Dressings and Kits, Umbilical cord clamps, High pressure lines, manifolds, stop cocks and syringes for angiography, Temperature Probes, Blood pressure cuffs, Esophageal Stethoscopes, Foley Catheters, Lubricants for patients, Defogger for endoscopy. Design, manufacture and distribution of procedure packs for surgical procedures and angio products and angio procedure trays.

Design, manufacture and distribution of Orthotic products: Spine Bracing, Ankle Bracing, Knee Bracing, Elbow Bracing, Shoulder Bracing, Fracture Bracing and Walkers. Design, manufacture and distribution of Orthopedic Softgoods: Cervical Collars and Traction, Clavicle Straps, Shoulder, Elbow and Knee Immobilizers, Arm Slings and Elevators, Elbow Support and Sleeves, Splints, Abdominal Binders and Belts, Supports, Post-op Shoes and Cast Shoes. Design, manufacture and distribution of Patient Protection products: Limb Holders, Vests, Hand Control Mittens, Ankle Contracture Boots, Fall Prevention, Supports and Foam Positioners. Design, manufacture and distribution of Rehabilitation products: Range of Motion and Splints. Design, manufacture and distribution of Temperature Therapy products: Units, Blankets and Thermal Wraps.

DGM-925 2022-04-30

DNA Diagnostic A/S
Voldbjergvej 14
8240 Risskov
Denmark

13485:2016 Production and Sale of Molecular Diagnostic Kit DGM-829 2020-05-03

Egoo.Health IVS
Borupvang 3
2750 Ballerup
Denmark

13485:2016 Manufacture and sales of optical electromechanical in-vitro diagnostic analyzers and reagents DGM-874 2022-03-14
Ellipse A/S
Agern Allé 11
2970 Hørsholm
Denmark
13485:2016 Development, design, production and service of IPL and Laser equipment for medical treatment DGM-459 2021-05-29
Ellipse A/S
Dr. Neergaards vej 5E
2970 Hørsholm
Denmark
13485:2016 Development, design, production and service of IPL and Laser equipment for medical treatment DGM-459 2021-05-29
Eldon Biological A/S
Sandtoften 10
2820 Gentofte
Denmark
13485:2016 Manufacture and final testing of dry format cards and assembly of kits for in vitro diagnostic blood type determination DGM-692 2020-01-31
Elltec Ltd.
Shirakawa No. 6, Co., Building
2-18-15, Nishiki Naka-ku
460 0003 Nagoya
Japan
13485:2016 Design, development, production and servicing of blood warmers DGM-559 2021-12-14

Fast Plast
Vilhelmsborgvej 2
7700 Thisted
Denmark

 9001:2015 Manufacture and sale of plastic disposables for tableware and plastic packaging to the medicine and food industry  DGM-838  2021-09-11
Ferrosan Medical Devices A/S
Sydmarken 5
2860 Søborg
13485:2016 Design, manufacture and final testing of absorbable gelatin products for haemostatic use DGM-709 2020-10-03

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

13485:2016 Production of customer specific examination tables DGM-834 2020-05-23
Heka Dental A/S
Baldershøj 38
2635 Ishøj
13485:2016 Production, test and service of dental units and dental chairs DGM-898 2020-06-02
Herlev Hospital
Substratafdelingen ved Klinisk
Mikrobiologisk Afdeling
Herlev Ringvej 75
2730 Herlev
Denmark
13485:2016 Udvikling, produktion og salg af dyrkningsmedier til mikrobiologisk diagnostik DGM-648 2021-11-08

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

13485:2016 Fremstilling og endelig kontrol af røde blodceller til in-vitro diagnostisk blodtypebestemmelse og screening af irregulære antistoffer mod erytrocytter DGM-807 2021-06-19
Innovison ApS
Skovvænget 2
5620 Glamsberg
Denmark
13485:2016 Design, production and servicing of cardiopulmonary function test equipment  DGM-864  2021-06-19
Intuitive Surgical, Inc.
1266 Kifer Road
Sunnyvale, CA 94086
USA
13485:2016 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 2021-01-03
Intuitive Surgical, Inc.
950 Kifer Road
Sunnyvale, CA 94086
USA
13485:2016 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 2021-01-03
Intuitive Surgical, Inc.
1450 Kifer Road
Sunnyvale, CA 94086
USA
13485:2016 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 2021-01-03

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

13485:2016 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 2021-01-03

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

13485:2016
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 2021-01-03

Intuitive Surgical Inc.
1650 TW Alexander Drive
Durham, NC 27703
USA

13485:2016 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 2021-01-03

Intuitive Surgical Inc.
4550 W. Watkins St.
Suite 120
Phoenix, AZ 85043
USA

13485:2016 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 2021-01-03
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
13485:2016 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 2021-01-03

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

13485:2016 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 2021-01-03

Intuitive Surgical, Sárl
1 Chemin des Mûriers
1170 Aubonne
Switzerland

13485:2016 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 2021-01-03

KEN HYGIENE SYSTEMS  A/S
Bøgebjergvej 60
5672 Broby
Denmark

13485:2016 Development and production of washer disinfectors. Sales and service of washer disinfectors, ultrasonic cleaners and sterilizers  DGM-878  2020-06-13

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

13485:2016 Development and production of washer disinfectors. Sales and service of washer disinfectors, ultrasonic cleaners and sterilizers
 DGM-878 2020-06-13

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

 13485:2016 Development and production of washer disinfectors. Sales and service of washer disinfectors, ultrasonic cleaners and sterilizers
 DGM-878 2020-06-13

KEN HYGIENE SYSTEMS s.r.o.
Južná trieda 74
040 01 Košice
Slovakia

 

13485:2016 Development and production of washer disinfectors. Sales and service of washer disinfectors, ultrasonic cleaners andsterilizers DGM-878 2020-06-13
Knudsen Plast A/S
Industrivej 21
3300 Frederiksværk
Denmark
13485:2016 Development of injection moulds, Injection moulding of plastic products, Assembly of injection moulded plastic products and Sterile packaging 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 Development of injection moulds, Injection moulding of plastic products, Assembly of injection moulded plastic products and Sterile packaging for the medical device industry.  DGM-641 2020-06-28

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

ISO 9001:2015, ISO 13485:2016 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 2021-09-12
Ladybalance ApS 13485:2016 Design, manufacture and sales of vaginal lactose tablets. DGM-921 2022-01-23
LBN Medical A/S
Gugvej 70
9210 Aalborg
13485:2016 Refurbishment of used medical imaging equipment and storage thereof DGM-690 2021-12-14
Lehiso A/S
Kongebakken 8
2765 Smørum
Denmark
13485:2016 Development and production of apps for hearing solutions DGM-884 2021-08-06
LGC Biosearch Technologies A/S
Voldbjergvej 16
8240 Risskov
Denmark
13485:2016 Contract manufacturer of synthetic oligonucleotides in support of molecular In-Vitro diagnostics and related industries. DGM-911 2021-06-29

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

13485:2016  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 2019-11-21

Medichanical Engineering ApS
Havneparken 2                                     7100 Vejle
Denmark

13485:2016 Manufacturing and servicing of orthopedic surgical measuring devices for non-vital physiological parameters.
DGM-860 2021-08-28

Philips-Medisize A/S
(Medicom Innovation Partner A/S)
Gimsinglundvej 20
7600 Struer
Denmark

13485:2016

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

DGM-369 2022-03-15
Medicopack A/S
Industrivej 6
5550 Langeskov
Denmark
 13485:2016
 Development, design, manufacture and distribution of bottloes and containers for medical use and of mixing devices for infusion fluids  DGM-656  2020-11-10
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
N.V. Organon
Kloosterstraat 6
5349 AN, Oss
The Netherlands
EN ISO 13485/2016 Post marketing surveillance of neuromuscular transmission monitors and handling of accessories and spare parts for neuromuscular transmission monitors DGM-865 2021-08-21
Nidacon International AB
Flöjesberggatan 16 B
431 37 Mölndal
Sweden
EN ISO 13485:2016 Design, development, manufacture, sales and marketing of medical devices for ART (Assisted Reproduction Technology) DGM-831 2021-08-18
Nrt, Nordisk Røntgen Teknik A/S
(NRT X-ray A/S)
Birkegårdsvej 16
8361 Hasselager
Denmark 
13485:2016 Design, development, production, installation and service of equipment for diagnostic medical X-ray systems  DGM-534 2021-03-21
Nunc A/S
Kamstrupvej 90
4000 Roskilde
Denmark
(Thermo Fisher Scientific, Roskilde Site)
13485:2016

Development, manufacture, and sterilization by irradiation medical devices for In Vitro Fertilization and storage and transport tubes and containers for In Vitro Diagnostic Use. Sub-contact irradiation of customer products to customer specification per. ISO 11137. 


DGM-770 2022-01-18
Nunc A/S
Kamstrupvej 90
4000 Roskilde
Denmark
(Thermo Fisher Scientific, Roskilde Site)
9001:2015

Development, manufacture and sterilization by irradiation of Laboratory plastic equipment. Sub-contract irradiation of customer products to customers specification per ISO 11137


DGM-916 2021-09-14
ORIGIO a/s
Knardrupvej 2
2760 Målev
Denmark
 13485:2016 Design, development, manufacture, final testing and distribution of storage devices, cell culture products, needles and catheters for use in assisted reproductive technology (ART) procedures. DGM-510

2020-01-09


Oslo Universitetssykehus HF
Avdeling for immunologi og transfusjonsmedisin
Ullevål Sykehus
Kirkeveien 166
0450 Oslo
Norway
13485:2016 Fremstilling af røde blodceller og serum/plasma fra humane bloddonorer til in vitro diagnostisk blodtypebestemmelse og antistoffscreening/identifisering DGM-775 2021-02-02
Oticon A/S
Kongebakken 9
2765 Smørum
Denmark
13485:2016 Development, production, sales and service of audiological solutions for better hearing
DGM-640 2021-09-27
Oticon A/S
DGS Denmark A/S
Tempovej 15
2750 Ballerup
Denmark
13485:2016 Development, production, sales and service of audiological solutions for better hearing DGM-640 2021-09-27
Oticon A/S
DGS Denmark A/S
Tilstedvej 73
7700 Thisted
Denmark
13485:2016 Development, production, marketing, sales and service of audiological solutions for better hearing DGM-640 2021-09-27
Oticon A/S
DGS Poland Sp. zo. o.
ul. Lubieszynska 59 Mierzyn,
72-006 Szczecin
Poland
13485:2016 Development, production, marketing,  sales and service of audiological solutions for better hearing DGM-640 2021-09-27
Oticon A/S
DGS Poland Sp. zo. o.
ul. Lubieszynska 42 Mierzyn,
72-006 Szczecin
Poland
13485:2016

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

DGM-640 2021-09-27

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

13485:2016

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

DGM-640 2021-09-27
Oy Medix Biochemica Ab
Klovinpellontie 3
02180 Espoo
Finland
13485:2016

The design and development, manufacture and distribution of reagents used in in-vitro diagnostic devices and controls


DGM-543 2020-11-03
Plum A/S
Frederik Plums Vej 2
5610 Assens
Denmark
13485:2016

Manufacture of wound rinse products, adhesive bandages and eye irrigation fluids for first aid.
Sale of cleansing pads, cooling gel and wound dressings for first aid and wipes for disinfection.


DGM-766 2021-11-08
PNN Medical A/S 
(Engineers & Doctors Wallsten Medical A/S)
Oldenvej 13
3490 Kvistgård
Denmark
13485:2016 Design, manufacturing and final inspection of urological stent systems and urological access systems
DGM-311 2021-09-04
Royal Sterilization Systems
A disvision of DeRoyal Industries, Inc.1135 Highway 33 South
New Tazewell, 37825 TN
USA
13485:2016 Ethylene oxide sterilization of medical devices and laboratory services for chemistry, microbiology, sterility and media preparation  DGM-537 2021-01-04

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

11135-1:2014

Ethylene oxide sterilization of medical devices

DGM-684

2021-01-04

Rønvig Dental Manufacturing A/S
Gl. Vejlevej 59
8721 Daugaard
Denmark

 

13485:2016

Development, production, servicing and marketing of dental products and electro-medical equipment

DGM-917

2021-10-12

SBO Hearing A/S
Kongebakken 9
2765 Smørum
Denmark

13485:2016

Development, production, marketing, sales and service of audiologic solutions for better hearing

DGM-914

2021-09-27

Sonic Innovations, Inc. 
2501 Cottontail Lane
NJ 08873,
USA
13485:2016 Development, production, marketing, sales and service of audiological solutions for better hearing
DGM-472 2021-09-27
SP Medical A/S
Møllevej 1
4653 Karise
Denmark
13485:2016 Design and development, production, trade anddistribution of medical devices made of metal, alloy, and plastics. Production, filling, assembly, packaging, coating and decoration of injection molded plastic and metal parts to be used for medical devices. DGM-728 2021-11-06    
SSI Diagnostica A/S
Herredsvejen 2
3400 Hillerød
13485:2016 Development, Manufacturing, Sales and Distribution of in vitro-diagnostica and blood products from animals DGM-893 2022-03-06
Technolution A/S
Lyngsø Allé
2970 Hørsholm
Denmark
13485:2016 Design, development of Medical Devices and IVD Medical Devices. Risk Management and Usability Engineering activities included
DGM-837 2020-07-10
Tonica Elektronik A/S 
Lucernermarken 15
3520 Farum
Denmark
13485:2016

Design of Magnetic stimulation equipment and Magnetic stimulation monitoring devices. Manufacture, testing and service of Magnetic stimulation equipment, Magnetic stimulation monitoring devices, therapeutic Intense pulsed light equipment, and Anesthetic gas mixing and monitoring systems.

DGM-511 2021-06-25
Unitron Hearing Ltd.
20 Beasley Drive,
Kitchener, ON N2E 1Y6
Canada
13485:2016 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 2021-05-18
Unitron Hearing Ltd.
250 Trillium Drive
Kitchener, ON N2E 1X2
Canada
13485:2016 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 2021-05-18

Vigmed AB
Garnisonsgatan 10
254 66 Helsingborg
Sweden

13485:2016 and 9001:2015 Development and manufacturing of single use medical devices for preventing needle stick injuries DGM-840 2020-06-26

Visiopharm A/S
Agern Allé 3
2970 Hørsholm
Denmark

13485:2016 Design, development, manufacture, installation and service of in vitro diagnostic pathology software  DGM-913 2021-12-28

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

13485:2016 Development, manufacture and marketing of products and systems for preparation, cultivation and storage of cells, intended for therapy DGM-845 2021-02-09

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

13485:2016 Production, installation and servicing of IVF incubators and IVF related accessories DGM-672 2021-06-19

 

Design, development, manufacture, installation and service of in vitro diagnostic pathology software