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Hexagonal Screwdriver 3.5
EUDAMEDClass I (EU MDR)
Ref OTA CR022Model Class Ir Instrument
Identity
- Trade Name
- HEXAGONAL SCREWDRIVER 3.5 EUDAMED
- Device Name
- Class Ir Instrument EUDAMED
- Model / Reference
- Class Ir Instrument EUDAMEDOTA CR022 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M483OTACR0220 EUDAMED
- Basic UDI-DI
- ++M483L0911YN EUDAMED
- Direct Marketing DI
- +M483OTACR0220 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
Hexagonal Screwdriver 3.5 by Groupe Lepine — 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 81c567aa-71e5-44c7-865d-f88c0116a9d6 61 fields · synced May 29, 2026