Skip to content

All Silicone Foley Catheter

by Well Lead Medical Co., Ltd. 432 variants

Ref AW6114, AW7106, AW7116, AW7112, AW6320, AW6C20, AW8114, AW8122, AW6318, AW7108, AW7120, AWB618, AW6C18, AW8116, AW6110, AW8120, AW6322, AWB624, AW6112, AW6106, AW6C22, AWB622Model 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, All Silicone Foley Catheter 2-way pediatric, All Silicone Foley Catheter 3-way Couvelaire, 3-way Dufour, 3-way Mercier, 3-way standard

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69449327FF01B00E4 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  • Withdrawn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 female, 2-way standard, 2-way open tip, 2-way tiemann, 2-way couvelaire, 2-way dufour, 2-way mercier, AW6114, All Silicone Foley Catheter 2-way pediatric, AW7106, AW7116, AW7112, AW6320, AW6C20, AW8114, AW8122, AW6318, AW7108, AW7120, All Silicone Foley Catheter 3-way Couvelaire, 3-way Dufour, 3-way Mercier, 3-way standard, AWB618, AW6C18, AW8116, AW6110, AW8120, AW6322, AWB624, AW6112, AW6106, AW6C22, AWB622
Primary DI / UDI-DI
06925816626999, 06925816652158, 06925816652202, 06925816652189, 06925816627095, 06925816652127, 06925816652257, 06925816652295, 06925816627088, 06925816652165, 06925816652226, 06925816652530, 06925816652110, 06925816652264, 06925816626975, 06925816652288, 06925816627101, 06925816652561, 06925816626982, 06925816626951, 06925816652134, 06925816652554
Basic UDI-DI
69449327FF01B00E4, 69449327FF01B01E6, 69449327FF01B09EN
EMDN Code
U010299 Urethral prostatic and bladder catheters, with balloon - other
Device Class
Class IIb
EU market of registration
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

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

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