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All Silicone Foley Catheter

by Well Lead Medical Co., Ltd. 432 variants

Ref HW6110, HWS616, HW6122, AW8A14, HW6108, AW8A12, AW8A20, AW8A22, HWS618, HWS614, HW6114, HW6118, AW7122, AW8A18Model All Silicone Foley Catheter 2-way pediatric, All Silicone Foley Catheter 2-way female, 2-way standard, 2-way open tip, 2-way tiemann, 2-way couvelaire, 2-way dufour, 2-way mercier

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69449327FF01B01E6 Basic UDI-DI Date2 Mar 2026RegisteredStatusActive

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.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
All Silicone Foley Catheter 2-way pediatric, HW6110, All Silicone Foley Catheter 2-way female, 2-way standard, 2-way open tip, 2-way tiemann, 2-way couvelaire, 2-way dufour, 2-way mercier, HWS616, HW6122, AW8A14, HW6108, AW8A12, AW8A20, AW8A22, HWS618, HWS614, HW6114, HW6118, AW7122, AW8A18
Primary DI / UDI-DI
06925816652455, 06925816652387, 06925816652516, 06925816652318, 06925816652448, 06925816652301, 06925816652349, 06925816652356, 06925816652394, 06925816652370, 06925816652479, 06925816652493, 06925816652233, 06925816652332
Basic UDI-DI
69449327FF01B01E6, 69449327FF01B00E4
EMDN Code
U010299 Urethral prostatic and bladder catheters, with balloon - other
Device Class
Class IIb
EU market of registration
France
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000006728
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Related devices

Category: Indwelling urethral drainage balloon catheter, non-antimicrobial

Other devices from Well Lead Medical Co., Ltd

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Properties

  • Sterile

Other properties (12)

  • 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