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Hydrophilic Latex Foley Catheter

by Well Lead Medical Co., Ltd. EUDAMED

Active European Union

Ref F01J201610Model 2-way, Standard

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69449327FF01E02EP Basic UDI-DIDate28 Aug 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  • Withdrawn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

Device Name
Latex Foley Catheter
Model / Reference
2-way, Standard, F01J201610
Primary DI / UDI-DI
06925816638930
Basic UDI-DI
69449327FF01E02EP
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

  • Sterile
  • Contains Latex

Other properties (11)

  • 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