DKMA
Competent authority · Denmark · Copenhagen
A national competent authority for medical devices under the EU MDR/IVDR — market surveillance, vigilance and EUDAMED registration oversight.
A national body that oversees the application of EU medical-device regulation in its country — market surveillance, vigilance, economic-operator validation and EUDAMED registration oversight, under MDR Articles 101–108.
Explore every authority and economic operator registered in Denmark.
A national body that oversees the application of EU medical-device regulation in its country — surveillance, vigilance, and registration oversight.
No — that's a notified body. A competent authority supervises the market; it does not issue device certificates.
Sourced directly from EUDAMED. This record was last updated Jun 29, 2026.
Operators whose registration was validated by this authority.
| Operator | Role | SRN | Country |
|---|---|---|---|
| 21Optical | Importer | DK-IM-000055374 | DK |
| 21Optical ApS | Authorised representative | DK-AR-000055229 | DK |
| 2cureX A/S | Manufacturer | DK-MF-000036335 | DK |
| 2SAN ApS | Importer | DK-IM-000012645 | DK |
| 2SAN ApS | Manufacturer | DK-MF-000017749 | DK |
| 3Shape A/S | Manufacturer | DK-MF-000001217 | DK |