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TufTex® Over-the-Wire Embolectomy Catheter

by LeMaitre Vascular, Inc. United States EUDAMED

Ref 1651-48M

EMDN C019002

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number08406631TufTexOTWAL Basic UDI-DIDate24 Sep 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
1651-48M
Primary DI / UDI-DI
00840663112098
Basic UDI-DI
08406631TufTexOTWAL
EMDN Code
C019002 Embolectomy catheters
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: TufTex® & Syntel® Catheters

Other devices from LeMaitre Vascular, Inc.

See all devices from LeMaitre Vascular, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Contains Latex
Other properties (11)
  • Implantable: No
  • Reusable: 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 330a6a95-21ca-463c-8f25-7f740ca806c9 61 fields · synced 22 Oct 2026