Identity
- Trade Name
- Prothesen Finish EUDAMED
- Device Name
- Prothesen Finish PLUS EUDAMED
- Model / Reference
- 485 EUDAMED100124 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04064797029336 EUDAMED
- Basic UDI-DI
- ++EPRM485EN EUDAMED
- EMDN Code
- P0199 PROSTHESES, FACIAL, ODONTOLOGICAL, AND CRANIAL - OTHERS 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
Prothesen Finish by PRISMAN GmbH — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | ++EPRM485EN | Class I | Active |
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Manufacturer
- Manufacturer
- PRISMAN GmbH
- EUDAMED SRN
- DE-MF-000009900
Sources (1)
- EUDAMED 9af76000-dbcd-4fdd-92a1-04278e7c6318 61 fields · synced Jul 30, 2026