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Silicone Foley Catheter

by Integral Medical Products Co., Ltd. EUDAMED

Active European Union

Ref FC16210DModel 2-way,Straight&open Tip

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06970675357249 Basic UDI-DIDate1 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Trade Name
bio-UMAXX 100% SILIKON FOLEY KATHETER
Device Name
Silicone Foley Catheter
Model / Reference
FC16210D, 2-way, Straight&open Tip
Primary DI / UDI-DI
06970675357249
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000009217
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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