Identity
- Trade Name
- DENAMARK single use EUDAMED
- Device Name
- DENAMARK single use EUDAMED
- Model / Reference
- M1501 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07649994323165 EUDAMED
- Basic UDI-DI
- 7649994323M1501C8 EUDAMED
- EMDN Code
- Z12011480 SURGICAL NAVIGATION INSTRUMENTS - HARDWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Neurological stereotactic surgery system
DENAMARK single use by Mininavident AG — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 7649994323M1501C8 | Class I | Active |
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Manufacturer
- Manufacturer
- Mininavident AG
- EUDAMED SRN
- CH-MF-000018879
- Authorised Representative
- Axxos GmbH DE-AR-000005590
Sources (1)
- EUDAMED 8ee73feb-f540-4ec7-926a-0743016cc18e 61 fields · synced Jun 19, 2026