Identity
- Trade Name
- Endo-Sigma-Set EUDAMED
- Device Name
- Tumor-OP-Set EUDAMED
- Model / Reference
- 66810273-14 EUDAMED66810420-15 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04034393779140 EUDAMED
- Basic UDI-DI
- 4034393CPTGEN2BWH EUDAMED
- EMDN Code
- H0199 SURGICAL SUTURES - OTHER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Medical Purpose
- Sterile, disposable procedure pack, combination of devices for injury or disease treatment related to general surgery. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Endo-Sigma-Set by Sengewald Klinikprodukte GmbH — Class IIb — 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 | 4034393CPTGEN2BWH | Class IIb | Active |
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Manufacturer
- Manufacturer
- Sengewald Klinikprodukte GmbH
- EUDAMED SRN
- DE-PR-000020748
Sources (1)
- EUDAMED e4d89cf3-b3a3-45e4-88ba-42ce5a7c524a 61 fields · synced Aug 4, 2026