Uni Gal Tibial Impactor End

EUDAMED

Class I (EU MDR)

Ref GGU IT001Model Class Ir Instrument

by groupe lépine

Identity

Trade Name: UNI GAL TIBIAL IMPACTOR END EUDAMED
Device Name: Class Ir Instrument EUDAMED
Model / Reference: Class Ir Instrument EUDAMED
GGU IT001 EUDAMED

Identifiers

Primary DI / UDI-DI: +M483GGUIT0010 EUDAMED
Basic UDI-DI: ++M483L0911YN EUDAMED
Direct Marketing DI: +M483GGUIT0010 EUDAMED
EMDN Code: L091104 ORTHOPAEDIC PROSTHESES POSITIONERS, REUSABLE EUDAMED

Classification

Device Class: Class I EUDAMED
Market of Registration: France EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

Yes

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Category: Orthopaedic implant impactor, reusable

Uni Gal Tibial Impactor End 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	++M483L0911YN	Class I	Active

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Manufacturer

Manufacturer: groupe lépine
EUDAMED SRN: FR-MF-000001182

Sources (1)

EUDAMED e8aa88ea-89c3-4648-b497-faaa9fb59206 61 fields · synced Jul 9, 2026