Identity
- Trade Name
- OP-Set EUDAMED
- Device Name
- Verband-Set, klein EUDAMED
- Model / Reference
- 6663498-01 EUDAMED66830463 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04034393750224 EUDAMED
- Basic UDI-DI
- 4034393CPTWOU2A7B EUDAMED
- EMDN Code
- T0202 SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Sterile, disposable procedure pack, combination of devices for injury alleviation related to wound care. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
OP-Set by Sengewald Klinikprodukte 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 | 4034393CPTWOU2A7B | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sengewald Klinikprodukte GmbH
- EUDAMED SRN
- DE-PR-000020748
Sources (1)
- EUDAMED ff6906f8-b1ea-4ab0-890d-7aa32ccaafba 61 fields · synced Sep 17, 2026