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Neoform Wrist Thumb Brace Xs/Lt
EUDAMEDClass I (EU MDR)
Ref CK-NWT-01LModel Orthopaedic Support Braces
by Trulife
Identity
- Trade Name
- NEOFORM WRIST THUMB BRACE XS/LT EUDAMED
- Device Name
- Orthopaedic Support Braces EUDAMED
- Model / Reference
- Orthopaedic Support Braces EUDAMEDCK-NWT-01L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056311110223 EUDAMED
- Basic UDI-DI
- 00643293OrthoX9 EUDAMED
- EMDN Code
- Y060613 WRIST-HAND-FINGERS ORTHOSES EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Neoform Wrist Thumb Brace Xs/Lt by Trulife — 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 | 00643293OrthoX9 | Class I | Active |
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Manufacturer
- Manufacturer
- Trulife
- EUDAMED SRN
- IE-MF-000003108
Sources (1)
- EUDAMED d0a9c034-0683-476d-afcc-f6a195ae6462 61 fields · synced Jul 30, 2026