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Trulife Clavicle Splint X-Large
EUDAMEDClass I (EU MDR)
Ref CK-CLA-09Model Orthopaedic Support Braces
by Trulife
Identity
- Trade Name
- TRULIFE CLAVICLE SPLINT X-LARGE EUDAMED
- Device Name
- Orthopaedic Support Braces EUDAMED
- Model / Reference
- Orthopaedic Support Braces EUDAMEDCK-CLA-09 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056311110117 EUDAMED
- Basic UDI-DI
- 00643293OrthoX9 EUDAMED
- EMDN Code
- Y060621 SHOULDER 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 Clavicle Splint X-Large 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 bb60e856-3707-4b08-8cd8-dd806f7454d1 61 fields · synced Jun 18, 2026