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Flexion Hemi Spacer H09
EUDAMEDClass I (EU MDR)
Ref GNANW174Model Class Ir InstrumentRef GNA BO009
Identity
- Trade Name
- FLEXION HEMI SPACER H09 EUDAMED
- Device Name
- Class Ir Instrument EUDAMED
- Model / Reference
- Class Ir Instrument EUDAMEDGNANW174 EUDAMEDGNA BO009 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M483GNANW1740 EUDAMED+M483GNABO0090 EUDAMED
- Basic UDI-DI
- ++M483L0909Z3 EUDAMED
- Direct Marketing DI
- +M483GNANW1740 EUDAMED+M483GNABO0090 EUDAMED
- EMDN Code
- L090999 ORTHOPAEDIC SURGERY CUTTING INSTRUMENTS, REUSABLE - OTHER EUDAMED
Classification
- Device Class
- Class I 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
Flexion Hemi Spacer H09 by groupe lépine — 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 | ++M483L0909Z3 | Class I | Active |
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Manufacturer
- Manufacturer
- groupe lépine
- EUDAMED SRN
- FR-MF-000001182
Sources (2)
- EUDAMED d179d24e-14d0-4f14-baad-27b048638421 61 fields · synced Jul 21, 2026
- EUDAMED 06734164-7211-417b-8e04-adab5f8a426a 61 fields · synced May 19, 2026