Medical device manufacturers in Denmark and the U.S. market
113 manufacturers registered in Denmark with at least 5 devices declared in the European database. Of these, 76 were not found in the U.S. FDA establishment register, 36 were matched, and 1 have a similar name that needs checking.
Against the Canadian register, 92 of them were not found, 20 hold a Health Canada licence, and 1 need checking.
| Manufacturer | Devices | FDA | Health Canada |
|---|---|---|---|
| Coloplast A/S | 11 480 | Registered with FDA | Licensed in Canada |
| SBO Hearing A/S | 10 427 | Not found in the FDA register | Licensed in Canada |
| WSAUD A/S | 8 641 | Not found in the FDA register | Not found in the Canadian register |
| Widex A/S | 2 913 | Not found in the FDA register | Not found in the Canadian register |
| Eto Garments ApS | 1 454 | Not found in the FDA register | Not found in the Canadian register |
| Dansac A/S | 912 | Not found in the FDA register | Not found in the Canadian register |
| Care Design I/S | 725 | Not found in the FDA register | Not found in the Canadian register |
| Borch Textile Group A/S | 720 | Not found in the FDA register | Not found in the Canadian register |
| GN Hearing A/S | 684 | Registered with FDA | Licensed in Canada |
| Pressalit A/S | 603 | Similar name found — unverified | Not found in the Canadian register |
| Etac A/S | 455 | Registered with FDA | Not found in the Canadian register |
| Winncare Nordic | 362 | Registered with FDA | Not found in the Canadian register |
| Natus Medical Denmark ApS | 358 | Registered with FDA | Licensed in Canada |
| Ambu A/S | 353 | Registered with FDA | Licensed in Canada |
| Etac Immedia A/S | 352 | Registered with FDA | Not found in the Canadian register |
| Levitate Technology ApS | 324 | Registered with FDA | Not found in the Canadian register |
| Mobilex A/S | 312 | Not found in the FDA register | Not found in the Canadian register |
| Excellent Systems A/S | 283 | Not found in the FDA register | Not found in the Canadian register |
| ZiboCare A/S | 271 | Not found in the FDA register | Not found in the Canadian register |
| MvG Consult ApS | 259 | Not found in the FDA register | Not found in the Canadian register |
| Protac A/S | 244 | Not found in the FDA register | Not found in the Canadian register |
| Cobi Rehab A/S | 207 | Not found in the FDA register | Not found in the Canadian register |
| DGS Diagnostics A/S | 176 | Not found in the FDA register | Licensed in Canada |
| R82 A/S | 160 | Registered with FDA | Not found in the Canadian register |
| BGI EUROPE A/S | 140 | Not found in the FDA register | Not found in the Canadian register |
| Simonsen & Weel A/S | 139 | Not found in the FDA register | Not found in the Canadian register |
| Schou Rasmussen ApS | 134 | Not found in the FDA register | Not found in the Canadian register |
| Furine ApS | 124 | Registered with FDA | Not found in the Canadian register |
| HMN A/S | 117 | Not found in the FDA register | Not found in the Canadian register |
| Ropox a/s | 115 | Registered with FDA | Not found in the Canadian register |
| Wolturnus A/S | 99 | Not found in the FDA register | Not found in the Canadian register |
| Levabo ApS | 97 | Not found in the FDA register | Not found in the Canadian register |
| CODAN Medical ApS | 86 | Registered with FDA | Not found in the Canadian register |
| Con-Lens ApS | 84 | Not found in the FDA register | Not found in the Canadian register |
| SSI Diagnostica A/S | 84 | Registered with FDA | Licensed in Canada |
| Vermund Larsen A/S | 68 | Not found in the FDA register | Not found in the Canadian register |
| CMS Dental | 64 | Not found in the FDA register | Licensed in Canada |
| Qufora A/S | 53 | Not found in the FDA register | Not found in the Canadian register |
| Vikta ApS | 51 | Not found in the FDA register | Not found in the Canadian register |
| Jb-Medico ApS | 47 | Not found in the FDA register | Not found in the Canadian register |
| Par Scientific Denmark ApS | 46 | Not found in the FDA register | Not found in the Canadian register |
| DANISH HEALTHCARE ApS | 45 | Not found in the FDA register | Not found in the Canadian register |
| QA MED Solutions | 45 | Not found in the FDA register | Not found in the Canadian register |
| Abena A/S | 41 | Not found in the FDA register | Licensed in Canada |
| DNTL Nordic ApS | 41 | Not found in the FDA register | Not found in the Canadian register |
| PF mobility ApS | 40 | Not found in the FDA register | Not found in the Canadian register |
| by ACRE Aps | 36 | Registered with FDA | Not found in the Canadian register |
| Select Sport A/S | 35 | Not found in the FDA register | Not found in the Canadian register |
| Cortex Technology Aps | 34 | Registered with FDA | Not found in the Canadian register |
| Eldon Biologicals A/S | 34 | Registered with FDA | Licensed in Canada |
| Knop Elektronik A/S | 33 | Not found in the FDA register | Not found in the Canadian register |
| PentaBase A/S | 33 | Not found in the FDA register | Not found in the Canadian register |
| Spilerdug ApS | 33 | Not found in the FDA register | Not found in the Canadian register |
| RefLab Aps | 31 | Not found in the FDA register | Not found in the Canadian register |
| Medema A/S | 30 | Not found in the FDA register | Not found in the Canadian register |
| ExamVision A/S | 29 | Registered with FDA | Not found in the Canadian register |
| Novo Nordisk A/S | 29 | Registered with FDA | Licensed in Canada |
| Vivostat A/S | 28 | Not found in the FDA register | Not found in the Canadian register |
| BiopSafe ApS | 26 | Not found in the FDA register | Not found in the Canadian register |
| Cercare Medical A/S | 26 | Registered with FDA | Not found in the Canadian register |
| Danrehab A/S | 25 | Not found in the FDA register | Not found in the Canadian register |
| NRT-Nordisk Røntgen Teknik A/S | 24 | Not found in the FDA register | Similar name found — unverified |
| Opitek International | 24 | Not found in the FDA register | Not found in the Canadian register |
| Sahva A/S | 24 | Not found in the FDA register | Not found in the Canadian register |
| Vitrolife A/S | 24 | Registered with FDA | Licensed in Canada |
| Prosenso ApS | 23 | Not found in the FDA register | Not found in the Canadian register |
| GP Medical Devices A/S | 21 | Registered with FDA | Not found in the Canadian register |
| Plum Safety ApS | 20 | Registered with FDA | Not found in the Canadian register |
| Canon Medical Informatics A/S | 19 | Registered with FDA | Licensed in Canada |
| JØRN IVERSEN RØDEKRO ApS | 19 | Not found in the FDA register | Not found in the Canadian register |
| Careturner A/S | 17 | Not found in the FDA register | Not found in the Canadian register |
| MelaMedic ApS | 17 | Not found in the FDA register | Not found in the Canadian register |
| Zantey ApS | 17 | Not found in the FDA register | Not found in the Canadian register |
| NUNC A/S | 15 | Registered with FDA | Licensed in Canada |
| CANNORDIC A/S | 14 | Not found in the FDA register | Not found in the Canadian register |
| Unigroup ApS | 14 | Not found in the FDA register | Not found in the Canadian register |
| 2cureX A/S | 13 | Not found in the FDA register | Not found in the Canadian register |
| Nordic-NeuroSTIM | 13 | Not found in the FDA register | Not found in the Canadian register |
| SmokeQuit ApS | 12 | Not found in the FDA register | Not found in the Canadian register |
| 3Shape TRIOS A/S | 11 | Registered with FDA | Licensed in Canada |
| Radiobotics ApS | 11 | Not found in the FDA register | Not found in the Canadian register |
| TOOsonix A/S | 11 | Not found in the FDA register | Not found in the Canadian register |
| BrainCapture ApS | 10 | Not found in the FDA register | Not found in the Canadian register |
| Nordic Sense A/S | 10 | Not found in the FDA register | Not found in the Canadian register |
| Unomedical A/S | 10 | Registered with FDA | Licensed in Canada |
| AAG Aalborg Gummivarefabrik A/S | 9 | Not found in the FDA register | Not found in the Canadian register |
| Auditdata A/S | 9 | Registered with FDA | Licensed in Canada |
| BK Medical ApS | 9 | Registered with FDA | Licensed in Canada |
| Innoventa Medica ApS | 9 | Registered with FDA | Not found in the Canadian register |
| Oscilla A/S | 9 | Registered with FDA | Not found in the Canadian register |
| Remecure ApS | 9 | Not found in the FDA register | Not found in the Canadian register |
| 3Shape A/S | 8 | Registered with FDA | Licensed in Canada |
| BY CONNIEHANSEN 2015 ApS | 8 | Not found in the FDA register | Not found in the Canadian register |
| Green Drain Europe ApS | 8 | Not found in the FDA register | Not found in the Canadian register |
| H. Dam Kærgaard A/S | 8 | Not found in the FDA register | Not found in the Canadian register |
| Henrotek A/S | 8 | Registered with FDA | Not found in the Canadian register |
| IVFtech ApS | 8 | Not found in the FDA register | Not found in the Canadian register |
| A/S Aabentoft | 7 | Not found in the FDA register | Not found in the Canadian register |
| Microwarm ApS | 7 | Not found in the FDA register | Not found in the Canadian register |
| Cortrium ApS | 6 | Not found in the FDA register | Not found in the Canadian register |
| DDD-Diagnostic A/S | 6 | Not found in the FDA register | Not found in the Canadian register |
| ExSeed Health ApS | 6 | Not found in the FDA register | Not found in the Canadian register |
| Ferrosan Medical Devices A/S | 6 | Registered with FDA | Licensed in Canada |
| Goloo A/S | 6 | Not found in the FDA register | Not found in the Canadian register |
| TA. Service A/S | 6 | Not found in the FDA register | Not found in the Canadian register |
| Axlab A/S | 5 | Not found in the FDA register | Not found in the Canadian register |
| Blue Ocean Robotics ApS | 5 | Not found in the FDA register | Not found in the Canadian register |
| Cardia International A/S | 5 | Not found in the FDA register | Not found in the Canadian register |
| CathVision ApS | 5 | Registered with FDA | Not found in the Canadian register |
| ErgoDenta ApS | 5 | Registered with FDA | Not found in the Canadian register |
| Kellpo A/S | 5 | Not found in the FDA register | Not found in the Canadian register |
| Monoqool | 5 | Registered with FDA | Not found in the Canadian register |
| XO CARE A/S | 5 | Not found in the FDA register | Not found in the Canadian register |
Other countries
- Germany (1071)
- Italy (805)
- France (491)
- United Kingdom (395)
- Poland (279)
- Spain (256)
- Netherlands (214)
- Switzerland (194)
- Sweden (163)
- Finland (131)
- Belgium (106)
- Czechia (97)
- Austria (79)
- Ireland (65)
- Portugal (58)