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Wellead Hydrophilic Intermittent Catheter F01L021420

by Well Lead Medical Co., Ltd

Ref F01L021420Model Ready to use Female/Standard/Tiemann

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69449327FF01L02FS Basic UDI-DI 06925816614507UDI-DIDate28 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06925816614507 UDI-DI Date3 Apr 2026ListedStatusListed GUDID: in commercial distribution

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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 24 Oct 2026.

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  • Withdrawn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
Hydrophilic Intermittent Catheter EUDAMED
Wellead Hydrophilic Intermittent Catheter GUDID
Generic Name
Intermittent urethral drainage catheter, non-antimicrobial, single-use
Model / Reference
F01L021420, Ready to use Female/Standard/Tiemann
Primary DI / UDI-DI
06925816614507 EUDAMED
06925816674051 GUDID
Basic UDI-DI
69449327FF01L02FS
510(k) Number
FDA Product Code
EZD
EMDN Code
U01010502 Nelaton catheters, non self-lubricating
GMDN Term
Intermittent urethral drainage catheter, non-antimicrobial, single-use
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
876.5130
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06925816614507
GUDID
06925816674051
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K241734)

Other devices from Well Lead Medical Co., Ltd

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

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

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