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GuideRight

by Lake Region Medical Inc. 6 variants

Part of a family of 84 devices: see the family page

Ref 404578-1

GuideRight (404578-1) is a device classified as Class III in the EU and Class II in the US made by Lake Region Medical, registered in EUDAMED on 5 May 2025 (Basic UDI-DI 081634901PTFEVASN2) with CE/MDR certificate TD745.179 valid until 15 Dec 2030 and listed in FDA GUDID since 24 Mar 2026 (UDI-DI 00816349013553), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

15 Dec 2030

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier National Standards Authority of Ireland (NSAI)

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00816349013553 UDI-DI Date24 Mar 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED NumberTD745.179 Date16 Dec 2025IssuedStatusActive expires 15 Dec 2030

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081634901PTFEVASN2 registered 5 May 2025 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00816349013553 listed 24 Mar 2026 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • TD745.179 Active

    Technical documentation EU MDR

    Certifier
    National Standards Authority of Ireland (NSAI) 0050
    Issued
    16 Dec 2025
    Expires
    15 Dec 2030

Timeline

4 dated events

  1. Registered EUDAMED 081634901PTFEVASN2
  2. Certificate issued EUDAMED TD745.179
  3. Listed FDA GUDID 00816349013553
  4. Certificate expires EUDAMED TD745.179

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Peripheral vascular guidewire, manual
Device name
PTFE Guidewires (Vascular)
Model / Ref / Catalog
404578-1
Primary DI / UDI-DI
00816349013553
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
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Length — 150 Centimeter
Outer Diameter — 0.035 Inch

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class III
GUDID
Class II

Device class is stated on each registry's own scale: Class III in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

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

Similar devices in this category

Other devices filed under PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES, NON-HYDROPHILIC.

Other devices from Lake Region Medical

  • Starter

    Class III

  • HiWire

    Class IIa

  • PV Tracker

    Class III

  • AddWire

    Class I

See all devices from Lake Region Medical →

Properties

  • Supplied sterile
  • Single use
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction)
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)