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Silicone Foley Catheter

by Guangzhou Orcl Medical Co., Ltd. China EUDAMED

Ref 91030015Model 3-way Standard: 18F EMDN U010201

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06972745361606 Basic UDI-DIDate17 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  • Withdrawn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 24 Oct 2026

Model / Reference
3-way Standard: 18F, 91030015
Primary DI / UDI-DI
06972745361606
Basic UDI-DI
B-06972745361606
EMDN Code
U010201 Urethral prostatic and bladder catheters, nelaton, with balloon
Device Class
Class IIa
Market of Registration
France

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 20c8c033-d041-4ebb-9317-bcd77817ac65 61 fields · synced 24 Oct 2026