← Back to catalogue
Extra Tib. Resection Guide L.
EUDAMEDClass I (EU MDR)
Ref GKABC311Model Class Ir Instrument
Identity
- Trade Name
- EXTRA TIB. RESECTION GUIDE L. EUDAMED
- Device Name
- Class Ir Instrument EUDAMED
- Model / Reference
- Class Ir Instrument EUDAMEDGKABC311 EUDAMED
Identifiers
- Primary DI / UDI-DI
- +M483GKABC3110 EUDAMED
- Basic UDI-DI
- ++M483L0909Z3 EUDAMED
- Direct Marketing DI
- +M483GKABC3110 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
Category: Bone cutting forceps, reusable
Extra Tib. Resection Guide L. by groupe lépine — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Bone cutting forceps, reusable.
- Acetabular Reamer 47mm — Viant Medical, LLC · Class IIa
- Gimmi — Gimmi GmbH · Class I
- GLOBAL UNITE — DePuy Ireland UC · Class I
- AG15-0002 — X.NOV MEDICAL TECHNOLOGY · Class I
- SPECIALIST 2 — DePuy Ireland UC · Class I
- Integra® Miltex® — Integra LifeSciences Production Corporation · Class I
- Acetabular Reamer 55mm — Viant Medical, LLC · Class IIa
- PED WIRE CUT W/TUNG INSERT SIDE BIT — Tecomet,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 | ++M483L0909Z3 | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- groupe lépine
- EUDAMED SRN
- FR-MF-000001182
Sources (1)
- EUDAMED 79830ea3-2928-46cd-8aed-a934a66d583b 61 fields · synced Jun 20, 2026