Identity
- Trade Name
- OP-Set 1 EUDAMED
- Device Name
- OP-Set 1 EUDAMED
- Model / Reference
- 38610-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04054858018300 EUDAMED
- Basic UDI-DI
- 405485838610-2S6 EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Set für operative Eingriffe, fachabteilungsübergreifend. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
OP-Set 1 by Fuhrmann GmbH — Class IIa — 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 | 405485838610-2S6 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fuhrmann GmbH
- EUDAMED SRN
- DE-PR-000019607
Sources (1)
- EUDAMED eb42941b-1892-42a3-a0a7-de966bd167a5 61 fields · synced Jun 18, 2026