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Shap3d
EUDAMEDClass I (EU MDR)
Ref 3DF/BL/2.85/1Model 061Ref 3DF/W/2.85/1Ref 3DF/BL/1.75/1Ref 3DF/B/2.85/0.5Ref 3DF/B/1.75/0.5Ref 3DF/BL/2.85/0.5Ref 3DF/OR/2.85/1
Identity
- Trade Name
- SHAP3D EUDAMED
- Device Name
- SHAP3D EUDAMED
- Model / Reference
- 061 EUDAMED3DF/BL/2.85/1 EUDAMED3DF/W/2.85/1 EUDAMED3DF/BL/1.75/1 EUDAMED3DF/B/2.85/0.5 EUDAMED3DF/B/1.75/0.5 EUDAMED3DF/BL/2.85/0.5 EUDAMED3DF/OR/2.85/1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 54011720038311 EUDAMED54011720038304 EUDAMED54011720038281 EUDAMED54011720038489 EUDAMED54011720038472 EUDAMED54011720038502 EUDAMED54011720038328 EUDAMED
- Basic UDI-DI
- 54200287061JU EUDAMED
- Direct Marketing DI
- 54011720038472 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
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
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 (7)
- EUDAMED 2917cd81-fa44-473e-99b8-7ecbbd974d3c 61 fields · synced Aug 3, 2026
- EUDAMED 8f71e161-c439-4494-a909-54e5024cadee 61 fields · synced May 16, 2026
- EUDAMED a6b945be-7558-47f6-9959-e31f892ec0eb 61 fields · synced May 16, 2026
- EUDAMED 126f82e3-1379-4f89-a6e1-d6996b1f3f8d 61 fields · synced May 16, 2026
- EUDAMED 2c61fa32-5a3a-4063-976d-7916a68edd44 61 fields · synced May 17, 2026
- EUDAMED f0fde288-3436-4fb8-8d74-5918aa9fcd80 61 fields · synced May 17, 2026
- EUDAMED 4cd53a45-be6f-4792-bf68-4baa3cd5d8db 61 fields · synced May 18, 2026