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All Silicone Foley Catheter

by Well Lead Medical Co., Ltd. EUDAMED

Active European Union

Ref F01B122420Model All Silicone Foley Catheter 3-way Couvelaire, 3-way Dufour, 3-way Mercier, 3-way standard

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69449327FF01B09EN Basic UDI-DIDate2 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
All Silicone Foley Catheter 3-way Couvelaire, 3-way Dufour, 3-way Mercier, 3-way standard, F01B122420
Primary DI / UDI-DI
06936881152603
Basic UDI-DI
69449327FF01B09EN
EMDN Code
U010299 Urethral prostatic and bladder catheters, with balloon - other
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

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

Other devices from Well Lead Medical Co., Ltd

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

Properties

Show 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