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Kneo Trial Fem Extrac. S01-S02
EUDAMEDClass I (EU MDR)
Ref GKAFEA00Model Class Ir Instrument
Identity
- Trade Name
- KNEO TRIAL FEM EXTRAC. S01-S02 EUDAMED
- Device Name
- Class Ir Instrument EUDAMED
- Model / Reference
- Class Ir Instrument EUDAMEDGKAFEA00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M483GKAFEA000 EUDAMED
- Basic UDI-DI
- ++M483L0911YN EUDAMED
- Direct Marketing DI
- +M483GKAFEA000 EUDAMED
- EMDN Code
- L091199 ORTHOPAEDIC PROSTHETICS 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
Kneo Trial Fem Extrac. S01-S02 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 | ++M483L0911YN | Class I | Active |
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Manufacturer
- Manufacturer
- groupe lépine
- EUDAMED SRN
- FR-MF-000001182
Sources (1)
- EUDAMED ed96abfa-7ca7-4a8c-837b-29900ab1540d 61 fields · synced Jul 29, 2026