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Starter

by Lake Region Medical Inc. EUDAMED

Active European Union

Ref SCMBF-126V

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberTD745.179 Date16 Dec 2025IssuedStatusActive expires 15 Dec 2030

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • TD745.179 Active

    Technical documentation EU MDR

    Notified body
    0050
    Issued
    16 Dec 2025
    Expires
    15 Dec 2030

Specification

EUDAMED

Device Name
PTFE Guidewires (Vascular)
Model / Reference
SCMBF-126V
Primary DI / UDI-DI
00816349012822
Basic UDI-DI
081634901PTFEVASN2
EMDN Code
C04020102 Peripheral vascular diagnostic guidewires, non-hydrophilic
Device Class
Class III
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000033013
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Lake Region Medical

  • Starter

    Class III

  • HiWire

    Class IIa

  • PV Tracker

    Class III

  • AddWire

    Class I

  • Starter

    Class III

  • Starter

    Class III

See all devices from Lake Region Medical →

Properties

  • Sterile
  • CMR Substance

Other properties (11)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No