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Latex Foley Catheter F01A021604

by Well Lead Medical Co., Ltd

Ref F01A021604Model 2-way, Standard

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 Number69449327FF01A00DX Basic UDI-DI 06944932760974UDI-DIDate20 Aug 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06944932760974 UDI-DI Date31 May 2024ListedStatusListed 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  • Withdrawn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
Latex Foley Catheter
Generic Name
Indwelling urethral drainage balloon catheter, non-antimicrobial
Model / Reference
F01A021604, 2-way, Standard
Primary DI / UDI-DI
06944932760974
Basic UDI-DI
69449327FF01A00DX
510(k) Number
FDA Product Code
MJC
EMDN Code
U010299 Urethral prostatic and bladder catheters, with balloon - other
GMDN Term
Indwelling urethral drainage balloon catheter, non-antimicrobial
Device Class
Class IIb 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
Device ClassEUDAMED
Class IIb
GUDID
Class II
Contains LatexEUDAMED
Yes
GUDID
No

Related devices

Category: Indwelling urethral drainage balloon catheter, non-antimicrobial

Cleared under the same submission (K082815)

Show all (12)

Other devices from Well Lead Medical Co., Ltd

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Properties

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

Other properties (17)

  • Implantable: No
  • Reusable: 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