Identity
- Trade Name
- Shunt Set EUDAMED
- Device Name
- Ögon Bakreset Mölndal EUDAMED
- Model / Reference
- 66229085-10 EUDAMED66822584-04 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04034393612553 EUDAMED
- Basic UDI-DI
- 4034393CPTORT2A53 EUDAMED
- EMDN Code
- Z12139099 VARIOUS ORTHOPAEDIC AND TRAUMATOLOGY INSTRUMENTS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Medical Purpose
- Sterile, disposable procedure pack, combination of devices for disease or injury treatment or compensation of a disability related to orthopedics. EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Category: Orthopaedic guidewire, reusable
Shunt 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 | 4034393CPTORT2A53 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Sengewald Klinikprodukte GmbH
- EUDAMED SRN
- DE-PR-000020748
Sources (1)
- EUDAMED ff3594e8-8362-4095-8963-88c74691ee5a 61 fields · synced Jul 17, 2026