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 |
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 |
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 |
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 | ||
| 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 | 2022-11-18 | ||
|
Codan Medical Aps |
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 |
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 |
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. |
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 |
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 |
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 catheters, rectal catheters, urine drainage bags, procedure packs and urine meters. | 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 | ||
| CryoConcepts, LP | 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 | 202-12-12 | ||
| 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. |
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 |
13485:2016 | Production and Sale of Molecular Diagnostic Kit | DGM-829 | 2023-04-20 | ||
|
Egoo.Health IVS |
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 | 2023-01-07 | ||
| 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 |
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 |
13485:2016 | Design and production of customer specific examination tables | DGM-834 | 2023-05-22 | ||
| 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 Borgmester Ib Juuls Vej 52, 5., 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 |
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. 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. |
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. |
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. |
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. |
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. |
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 |
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 |
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 |
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 |
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.
|
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 |
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 | ||
| 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 |
13485:2016 |
Development and production of fecal irrigation systems. |
DGM-631 | 2021-02-15 | ||
|
Medichanical Engineering ApS |
13485:2016 | Manufacturing and servicing of orthopedic surgical measuring devices for non-vital physiological parameters. |
DGM-860 | 2021-08-28 | ||
|
Philips-Medisize A/S |
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 |
13485:2016 | Design, manufacture, sales 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 | 2022-12-30 |
||
| 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 |
||
| 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 | ||
| KiiltoClean A/S (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. |
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 | ||
| Reckitt Benckiser France 102 Rue de Sours 2008 Chartres France |
13485:2016 | Manufacture and Primary Packaging of Non-Sterile Medical Devices such as 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 | 2021-01-04 | ||
|
Royal Sterilization Systems |
11135-1:2014 |
Ethylene oxide sterilization of medical devices |
DGM-684 |
2021-01-04 |
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Rønvig Dental Manufacturing A/S
|
13485:2016 |
Development, production, servicing and marketing of dental products and electro-medical equipment |
DGM-917 |
2021-10-12 |
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| 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 | ||
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Vigmed AB |
13485:2016 and 9001:2015 | Development and manufacturing of single use medical devices for preventing needle stick injuries | DGM-840 | 2020-06-26 | ||
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Visiopharm A/S |
13485:2016 | Design, development, manufacture, installation and service of in vitro diagnostic pathology software | DGM-913 | 2021-12-28 | ||
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Vitrolife Sweden AB |
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 | ||
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Vitrolife A/S |
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