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Uni Gal Trial Insert S4 H08
EUDAMEDClass IIa (EU MDR)
Ref GGU SE408Model Orthopaedic prostheses positioners, reusable
Identity
- Trade Name
- UNI GAL TRIAL INSERT S4 H08 EUDAMED
- Device Name
- Orthopaedic prostheses positioners, reusable EUDAMED
- Model / Reference
- Orthopaedic prostheses positioners, reusable EUDAMEDGGU SE408 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M483GGUSE4080 EUDAMED
- Basic UDI-DI
- ++M483L091104F9 EUDAMED
- Direct Marketing DI
- +M483GGUSE4080 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
Uni Gal Trial Insert S4 H08 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 4309cba8-d4ef-4236-9cc8-ed838baf8d8f 61 fields · synced Jul 30, 2026