Identity
- Trade Name
- Fixateur-Set EUDAMED
- Device Name
- LSK-Set EUDAMED
- Model / Reference
- 66827194-12 EUDAMED66801283-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04034393808703 EUDAMED
- Basic UDI-DI
- 4034393CPTGEN2AWF EUDAMED
- EMDN Code
- M0499 SPECIAL DRESSINGS - OTHER EUDAMED
Classification
- Device Class
- Class IIa 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
Category: Scar-management dressing, reusable
Fixateur-Set by Sengewald Klinikprodukte GmbH — Class IIa — 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 | 4034393CPTGEN2AWF | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sengewald Klinikprodukte GmbH
- EUDAMED SRN
- DE-PR-000020748
Sources (1)
- EUDAMED 6c2b46a1-f8ff-44fc-af9f-48d77886c90e 61 fields · synced Jul 14, 2026