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Urological Guide Wire U01B133815

by Well Lead Medical Co., Ltd

Part of a family of 10 devices: see the family page

Ref U01B133815Model HybriGlide Guide Wire

Urological Guide Wire U01B133815 is a device classified as Class IIa in the EU and Class II in the US made by Well Lead Medical Co., Ltd, registered in EUDAMED on 27 Oct 2026 (Basic UDI-DI 69449327FU01B15LL) and listed in FDA GUDID since 6 Jan 2023 (UDI-DI 06936881176685), active as of 7 Nov 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69449327FU01B15LL Basic UDI-DI 06936881176685UDI-DIDate27 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06936881176685 UDI-DI Date6 Jan 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 69449327FU01B15LL registered 27 Oct 2026 Active
  • FDA GUDID UDI-DI 06936881176685 listed 6 Jan 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 06936881176685
  2. Registered EUDAMED 69449327FU01B15LL

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  • Withdrawn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

Trade name
Urological Guide Wire
Generic name
Cardiac/peripheral vascular guidewire, single-use
Model / reference
U01B133815, HybriGlide Guide Wire
Primary DI / UDI-DI
06936881176685 EUDAMED
06936881148361 GUDID
Basic UDI-DI
69449327FU01B15LL
FDA product code
OCY
EMDN code
U0601 Urological guidewires, hydrophilic
GMDN term
Cardiac/peripheral vascular guidewire, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1500
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06936881176685
GUDID
06936881148361
Device classEUDAMED
Class IIa
GUDID
Class II

The registries describe this device under different primary UDI-DIs (EUDAMED lists 06936881176685; FDA GUDID lists 06936881148361), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Cardiac/peripheral vascular guidewire, single-use

Similar devices in this category

Other devices filed under UROLOGICAL GUIDEWIRES, HYDROPHILIC.

Other devices from Well Lead Medical Co., Ltd

See all devices from Well Lead Medical Co., Ltd →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)