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Flexion Spacer Block H13
EUDAMEDClass I (EU MDR)
Ref GKASF113Model Class Ir InstrumentRef GKASF013
Identity
- Trade Name
- FLEXION SPACER BLOCK H13 EUDAMED
- Device Name
- Class Ir Instrument EUDAMED
- Model / Reference
- Class Ir Instrument EUDAMEDGKASF113 EUDAMEDGKASF013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M483GKASF1130 EUDAMED+M483GKASF0130 EUDAMED
- Basic UDI-DI
- ++M483L0909Z3 EUDAMED
- Direct Marketing DI
- +M483GKASF1130 EUDAMED+M483GKASF0130 EUDAMED
- EMDN Code
- L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE 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
Category: Orthopaedic implant impactor, reusable
Flexion Spacer Block H13 by groupe lépine — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 a41e111f-84a1-4592-b076-68b0788c1ad5 61 fields · synced Jul 22, 2026
- EUDAMED 2abfe802-c7c1-4f7e-b402-2594d071c99a 61 fields · synced May 17, 2026