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Trial Head Ø28 +3.5
EUDAMEDClass IIa (EU MDR)
Ref HTA CL428Model Orthopaedic prostheses positioners, reusable
Identity
- Trade Name
- TRIAL HEAD Ø28 +3.5 EUDAMED
- Device Name
- Orthopaedic prostheses positioners, reusable EUDAMED
- Model / Reference
- Orthopaedic prostheses positioners, reusable EUDAMEDHTA CL428 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M483HTACL4280 EUDAMED
- Basic UDI-DI
- ++M483L091104F9 EUDAMED
- Direct Marketing DI
- +M483HTACL4280 EUDAMED
- EMDN Code
- L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
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
Trial Head Ø28 +3.5 by groupe lépine — Class IIa — 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 | ++M483L091104F9 | Class IIa | Active |
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Manufacturer
- Manufacturer
- groupe lépine
- EUDAMED SRN
- FR-MF-000001182
Sources (1)
- EUDAMED 79489ab5-0f1f-4d83-8ddb-d565b72508d3 61 fields · synced Jun 20, 2026