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Thermoplastic material for orthotics and prosthetics.
EUDAMEDClass I (EU MDR)
Ref 37SS/4480BModel Orfitrans
Identity
- Trade Name
- Thermoplastic material for orthotics and prosthetics. EUDAMED
- Device Name
- Orfitrans EUDAMED
- Model / Reference
- Orfitrans EUDAMED37SS/4480B EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05420028722381 EUDAMED
- Basic UDI-DI
- 5420028700014L EUDAMED
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Belgium 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
Thermoplastic material for orthotics and prosthetics. by Orfit Industries — 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 | 5420028700014L | Class I | Active |
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Manufacturer
- Manufacturer
- Orfit Industries
- EUDAMED SRN
- BE-MF-000007872
Sources (1)
- EUDAMED 23a63066-a944-46cc-8832-8b5c264869bb 61 fields · synced Jun 19, 2026