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GuideRight

by Lake Region Medical Inc. EUDAMEDGUDID

Active European Union

Ref 404844-1

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00816349013621 UDI-DIDate24 Mar 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED NumberTD745.179 Date16 Dec 2025IssuedStatusActive expires 15 Dec 2030

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

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

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Generic Name
Peripheral vascular guidewire, manual
Device Name
PTFE Guidewires (Vascular)
Model / Ref / Catalog
404844-1
Primary DI / UDI-DI
00816349013621
Basic UDI-DI
081634901PTFEVASN2
FDA Product Code
DQX
EMDN Code
C04020102 Peripheral vascular diagnostic guidewires, non-hydrophilic
GMDN Term
Peripheral vascular guidewire, manual
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
870.1330
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Length — 260 Centimeter
Outer Diameter — 0.035 Inch

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

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
  • Single Use
  • CMR Substance
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No