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Silicone Foley Catheter

by Guangzhou Orcl Medical Co., Ltd. China EUDAMED

Ref 91030003Model 2-way Paediatric:10Fr EMDN U020101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06972745361422 Basic UDI-DIDate12 Mar 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  • Withdrawn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 · synced 25 Oct 2026

Model / Reference
2-way Paediatric:10Fr, 91030003
Primary DI / UDI-DI
06972745361422
Basic UDI-DI
B-06972745361422
EMDN Code
U020101 Ureteral catheters with cylindrical tip
Device Class
Class IIa
Market of Registration
Finland

Manufacturer details

EUDAMED SRN
CN-MF-000039222
Authorised representative
Wellkang Ltd XI-AR-000001836

Other devices from Guangzhou Orcl Medical Co., Ltd.

See all devices from Guangzhou Orcl Medical Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Contains Latex
Other properties (9)
  • Implantable: No
  • Reusable: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 24875759-592a-4ad0-934c-a0e49ef33cf5 61 fields · synced 25 Oct 2026