Identity
- Trade Name
- OP-Set EUDAMED
- Device Name
- OP-Set EUDAMED
- Model / Reference
- 37827-2 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04054858315607 EUDAMED
- Basic UDI-DI
- 405485837827-2TR EUDAMED
- EMDN Code
- V0599 CLINICAL PROCEDURES KITS NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Medical Purpose
- Behandlungseinheit für die Durchführung eines sterilen Verbandwechsels. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: Ophthalmic surgical procedure kit, non-medicated, single-use
OP-Set by Fuhrmann GmbH — 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 | 405485837827-2TR | Class I | Active |
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Manufacturer
- Manufacturer
- Fuhrmann GmbH
- EUDAMED SRN
- DE-PR-000019607
Sources (1)
- EUDAMED bfaf689f-842f-4150-a889-06ff1073f241 61 fields · synced Jun 17, 2026