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Splint-Fix 33
EUDAMEDClass I (EU MDR)
Ref 60-13Model Stabilisierungs- und Lagerungsschiene
Identity
- Trade Name
- Splint-Fix 33 EUDAMED
- Model / Reference
- Stabilisierungs- und Lagerungsschiene EUDAMED60-13 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04260402642437 EUDAMED
- Basic UDI-DI
- 42604026423359 EUDAMED
- EMDN Code
- V0804 PATIENT IMMOBILISERS (in diagnostic or therapeutic procedures) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Splint-Fix 33 by Novo Klinik-Service GmbH — Class I — 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 | 42604026423359 | Class I | Active |
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Manufacturer
- Manufacturer
- Novo Klinik-Service GmbH
- EUDAMED SRN
- DE-MF-000005289
Sources (1)
- EUDAMED 5234b865-61dc-438a-b162-aa2f3d542b86 61 fields · synced Jun 18, 2026