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Modular Impaction Handle
EUDAMEDClass I (EU MDR)
Ref GKAIM002Model Class Ir InstrumentRef GKAIM001
Identity
- Trade Name
- MODULAR IMPACTION HANDLE EUDAMED
- Device Name
- Class Ir Instrument EUDAMED
- Model / Reference
- Class Ir Instrument EUDAMEDGKAIM002 EUDAMEDGKAIM001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M483GKAIM0020 EUDAMED+M483GKAIM0010 EUDAMED
- Basic UDI-DI
- ++M483L0911YN EUDAMED
- Direct Marketing DI
- +M483GKAIM0020 EUDAMED+M483GKAIM0010 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
Modular Impaction Handle by groupe lépine — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthopaedic implant impactor, reusable.
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- Integra® — Ascension Orthopedics, Inc. · Class I
- R3 — Smith & Nephew, Inc. · Class I
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 | ++M483L0911YN | Class I | Active |
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Manufacturer
- Manufacturer
- groupe lépine
- EUDAMED SRN
- FR-MF-000001182
Sources (2)
- EUDAMED 0ba8a3c2-c13b-4886-9f22-80eedaed891d 61 fields · synced Jul 14, 2026
- EUDAMED 26b054b7-92e3-4a1e-bdb9-b1e5b7dda18b 61 fields · synced May 17, 2026