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Trulife Pk 6 Med/Rt Classic Wrist Br
EUDAMEDClass I (EU MDR)
Ref CK-FTC-03RModel Orthopaedic Support Braces
by Trulife
Identity
- Trade Name
- TRULIFE PK 6 MED/RT CLASSIC WRIST BR EUDAMED
- Device Name
- Orthopaedic Support Braces EUDAMED
- Model / Reference
- Orthopaedic Support Braces EUDAMEDCK-FTC-03R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056311110179 EUDAMED
- Basic UDI-DI
- 00643293OrthoX9 EUDAMED
- EMDN Code
- Y060612 WRIST-HAND 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
Trulife Pk 6 Med/Rt Classic Wrist Br 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 11f102f1-d4c0-4478-9825-02756c93a141 61 fields · synced Jul 31, 2026