Identity
- Trade Name
- SHAP3D EUDAMED
- Device Name
- SHAP3D EUDAMED
- Model / Reference
- 061 EUDAMED3DF/B/2.85/1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 54011720038274 EUDAMED
- Basic UDI-DI
- 54200287061JU EUDAMED
- EMDN Code
- Y060613 WRIST-HAND-FINGERS ORTHOSES 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
Yes
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
Shap3d 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 | 54200287061JU | Class I | Active |
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Manufacturer
- Manufacturer
- Orfit Industries
- EUDAMED SRN
- BE-MF-000007872
Sources (1)
- EUDAMED 2bb4dc16-fc3a-463d-8ae9-edf71e9a8f28 61 fields · synced Jun 18, 2026