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OP Set Plastiker, klein
EUDAMEDClass IIa (EU MDR)
Ref 66829914-02Model 66231555-01
Identity
- Trade Name
- OP Set Plastiker, klein EUDAMED
- Device Name
- Plastikset Borås EUDAMED
- Model / Reference
- 66231555-01 EUDAMED66829914-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04034393726250 EUDAMED
- Basic UDI-DI
- 4034393CPTPLA2AZ2 EUDAMED
- EMDN Code
- Q030316 ENT SURGERY INSTRUMENT KITS NOT INCLUDED IN OTHER CLASSES, SINGLE-USE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Sterile, disposable procedure pack, combination of devices for disease treatments or modification of the anatomy related to plastic surgery. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
OP Set Plastiker, klein 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 | 4034393CPTPLA2AZ2 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sengewald Klinikprodukte GmbH
- EUDAMED SRN
- DE-PR-000020748
Sources (1)
- EUDAMED e15c876b-e6ef-4292-809b-f9bc3db63c41 61 fields · synced Sep 18, 2026