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LeMaitre® Valvulotome

by LeMaitre Vascular, Inc. United States EUDAMED

Ref 1010-00M

EMDN C019017

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08406631LMATVtomAV Basic UDI-DIDate16 Sep 2024RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
1010-00M
Primary DI / UDI-DI
00840663111176
Basic UDI-DI
08406631LMATVtomAV
EMDN Code
C019017 Valvulotomes, single-use
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000016778
Authorised representative
LeMaitre Vascular GmbH DE-AR-000013539

From the manufacturer

Manufacturer's product page: Over-the-Wire LeMaitre® Valvulotome

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (12)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 0f334e2d-e05a-4c9a-9994-a14df27b754f 61 fields · synced 23 Oct 2026