Impaction End Flat M10

EUDAMED

Class I (EU MDR)

Ref HL1300-005-04Model Class Ir Instrument

by groupe lépine

Identity

Trade Name: IMPACTION END FLAT M10 EUDAMED
Device Name: Class Ir Instrument EUDAMED
Model / Reference: Class Ir Instrument EUDAMED
HL1300-005-04 EUDAMED

Identifiers

Primary DI / UDI-DI: +M483HL1300005040 EUDAMED
Basic UDI-DI: ++M483L0911YN EUDAMED
Direct Marketing DI: +M483HL1300005040 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

Impaction End Flat M10 by groupe lépine — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Orthopaedic implant impactor, reusable.

MobiliT Cup — CORIN LTD · Class II
R3 — Smith & Nephew, Inc. · Class II
MobiliT Cup — CORIN LTD · Class II
KMEDIC — TELEFLEX INCORPORATED · Class I
R3 — Smith & Nephew, Inc. · Class I
Head Impactor — Metrimed Orvosi Műszergyártó Kft. · Class I
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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

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

Sources (1)

EUDAMED b592fb70-0a7e-4316-979b-7b711b1a25a6 61 fields · synced Jun 18, 2026