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 

Abena A/S
Egelund 35
6200 Åbenrå
Denmark
&
Askelund 1
6200 Åbenrå
Denmark
&
Egelund 30
6200 Åbenrå
Denmark



































13485:2016








































Manufacturing, distribution, purchasing, and sales within the product areas:
Incontinence/urology: diapers, catheters, bags, male external
catheters, irrigation
Wound care: dressings, napkins, bandages, tape, plasters, change kits, tweezers, wound care and pressure-relieving products.
Personal procetive equipment: headgear, gowns, disposable suits, warm jackets, patient clothing, bed linen, blankets, shoe covers, cuffs, aprons, bibs, face masks, gloves
Bed protection: paqds, drawsheet
Medical supplies: bags, masks, tubes, inhalation equipment, surgical instruments (non-sterile), syringes, needles, suture
Clinnic equipment: screens, lighting, tables, bed, chair, vision test boards, scales, height rods
First aid products: emergency treatment, burns, first aid equipment, resuscitation, immobilization, cold/heat treatment, eye wash
Medicine management: boxes, storage
Stoma: cap, paunch
Clinical nutritional accessories: probes, containers, syringes, tubes, bags
Compression: compression stocking, assortment for stocking
DGM-943








































 
2024-05-06







































Ambi Pack BV
De Zelling 17
3342 GS Hendrik-Ido-Ambacht
The Netherlands

13485:2016 Mixing, tableting, capsulating and packing of oral and topical administered products registered as medical devices DGM-816 2023-06-22

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 2024-03-12
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 2023-04-08
BK Medical ApS
Mileparken 34
2730 Herlev
Denmark
13485:2016 Design, development, manufacturing and service of medical ultrasound devices DGM-539 2022-12-20
Cerebriu A/S
Lautrupvej 40
2750 Ballerup
Denmark
13485:2016  Design and development of software for radiological workflow support, medical image quantification, and visualization DGM-937 2024-03-15

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 2024-01-06

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 2024-09-08

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 2024-09-08
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 2024-09-08
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 2024-09-08
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 2024-09-08
Coloplast GmbH
Kuehnstrasse 75
22045 Hamburg
Germany
13485:2016 Sale and distribution of medical devices. In addition patient counseling and patient care services related to the supply of medical devices products. DGM-651 2023-12-01
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 2024-09-08
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 2024-09-08
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 2024-09-08
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 2024-09-08
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 2024-09-08

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 2024-09-08
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 2024-09-08
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 2024-09-08
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 2024-09-08
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 2024-09-08
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 2024-09-08
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 2024-09-08
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 2024-09-08
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 2024-09-08
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 2024-09-08
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 2024-09-08
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 2024-09-08

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 2024-09-08

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 2024-09-08
Coloplast AB
Kungsparksvägen 2
43422 Kungsbacka
Sweden
13485:2016 &
9001:2005
Sales and distribution on the Swedish market, of medical devices for ostomy, urology and continence care products  DGM-933 2023-06-24 
Continence Care ApS
Islevdalvej 184
2610 Rødovre
Denmark
13485:2016 Manufacture of sterile urology catheters, rectal catheters, urine drainage bags, procedure packs and urine meters. DGM-593 2024-03-19
Cortex Technology ApS 
Plastvænget 9
9560 Hadsund
Denmark
13485:2016 Manufacture, testing and service of cryosurgical units
and cryosurgical accessories 
DGM-610 2024-09-30

Covidien IIc 
15 Hampshire Street
Mansfield, MA 02048
USA

&

540 Oakmead Parkway
Sunnyvale, CA 94085
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 2024-11-09
CryoConcepts, LP
205 Webster Stree
18015 Bethlehem
Pennsylvia
USA
13485:2016 The design, manufacture and distribution of disposable cryosurgical devices intended for the surgical destruction of target tissue by applying cryogenic gases DGM-930 2022-12-12
DDD-Diagnostic A/S
Kærvej 12
2970 Hørsholm
Denmark
13485:2016 Design, development, production, installation and servicing of gamma cameras DGM-509 2023-12-03

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 2023-04-20
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 2023-01-07

Fast Plast
Vilhelmsborgvej 2
7700 Thisted
Denmark

 9001:2015 Manufacture and sales of single use plastic articles and packaging for the medicinal and food industry  DGM-838 2024-12-11
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 2023-10-02
Heka Dental A/S
Baldershøj 38
2635 Ishøj
13485:2016 Production, test and service of dental units and dental chairs DGM-898 2023-06-02
Herlev Hospital
Substratafdelingen ved Klinisk
Mikrobiologisk Afdeling
Borgmester Ib Juuls Vej 52, 5.,
2730 Herlev
Denmark
13485:2016 Udvikling, produktion og salg af dyrkningsmedier til mikrobiologisk diagnostik DGM-648 2024-11-08

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

13485:2016 Manufacturing and final control of blood cells for in-vitro diagnostic determining the blood groups and screening for irregular anti-erythrocytic antibodies DGM-807 2024-06-14

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 2023-06-12

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 2023-06-12

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 2023-06-12

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 2023-06-12
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 2023-06-26
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 2023-06-26

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 2023-09-08
LGC Biosearch Technologies A/S
Voldbjergvej 16
8240 Risskov
Denmark
&
Sønderskovvej 5
8520 Lystrup
Denmark
13485:2016 Contract manufacturer of synthetic oligonucleotides in support of molecular In-Vitro diagnostics and related industries. DGM-911 2024-03-25

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 2024-06-17

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 2024-02-01
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 2022-04-18
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 2022-03-14

Open TeleHealth APS
Balticgade 11, st
8000 Århus C
Denmark

13485:2016

Design, production, installation, service and sale of tele medical software solutions

DGM-943 2023-06-26
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 2024-02-01
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 and connected digital health solutions  DGM-369 2023-12-10
Plum Safety ApS
Mandelalleen 1
5610 Assens
Denmark
13485:2016 Manufacture of plasters and eye irrigation fluids for first aid. Sales of cleansing wipes, cooling gel and wound dressings for first aid and wipes for disinfection DGM-940 2024-04-19
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 2024-12-04
Prostatype Genomics AB
Industrivägen 19
171 48 Solna
Sweden
&
Banvaktsvägen 22
171 48 Solna
Sweden
13485:2016 Manufacture of IVD reagents and software tools for the evaluation of patients with prostatate cancer DGM-890 2022-03-27
Qlife Aps
Borupvang 3
2750 Ballerup
13485:2016 Manufacture and sales of optical electromechanical in-vitro diagnostic analtzers and reagents DGM-874 2022-03-14
Qufora A/S
Gydevang 28-30
3450 Allerød
Denmark
 13485:2016 Development and production of fecal irrigation systems. Import and distribution of hydrophilic urinary catheters, urinary balloon catheters, lubrication gel, urine bags with accessories and male external catheters.  DGM-631 2024-02-15
Reckitt Benckiser France
102 Rue de Sours
2008 Chartres
France
13485:2016 Manufacture and Primary Packaging of general non-active, non-implantable devices including Corn Treatment Pen, Fungal Nail Treatment DGM-929 2022-12-21    
         
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 2022-03-05

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

2022-03-05

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

2023-09-11

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
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 2024-03-22
Unitron Hearing Ltd.
20 Beasley Drive,
Kitchener, ON N2E 1Y6
Canada
&
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 2024-05-07

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 2023-06-12

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 2024-02-02

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

13485:2016 Design, development, production, installation and servicing of IVF incubators and IVF related accessories DGM-672 2024-06-15

 

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