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HiWire

by Lake Region Medical Inc. EUDAMED

Active European Union

Ref HW-025150-02

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number081634901HydroUROE2 Basic UDI-DIDate16 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Specification

EUDAMED

Device Name
Guidewire: Hydrophilic (Non-Vascular)
Model / Reference
HW-025150-02
Primary DI / UDI-DI
00816349015182
Basic UDI-DI
081634901HydroUROE2
EMDN Code
U0601 Urological guidewires, hydrophilic
Device Class
Class IIa
Market of Registration
Ireland

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

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