DE/CA29
Competent authority · Germany · Wiesbaden
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 Germany.
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 25, 2026.
Operators whose registration was validated by this authority.
| Operator | Role | SRN | Country |
|---|---|---|---|
| MEDICLUS Co., Ltd. | Manufacturer | KR-MF-000022584 | KR |
| 21 Century Medical Co., Ltd. | Manufacturer | KR-MF-000009204 | KR |
| AB Medical, Inc. | Manufacturer | KR-MF-000026779 | KR |
| Abbott Diagnostics GmbH | Importer | DE-IM-000007589 | DE |
| Abbott Diagnostics GmbH | Authorised representative | DE-AR-000007588 | DE |
| Abbott GmbH | Importer | DE-IM-000007590 | DE |