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Silicone Foley Catheter

by Guangzhou Orcl Medical Co., Ltd. 18 variants

Ref 91030004Model 2-way Standard: 12Fr

Active European Union

CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06972745361446 Basic UDI-DI 06972745361446UDI-DIDate12 Mar 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Model / Reference
2-way Standard: 12Fr, 91030004
Primary DI / UDI-DI
06972745361446
Basic UDI-DI
B-06972745361446
EMDN Code
U010201 Urethral prostatic and bladder catheters, nelaton, with balloon
Device Class
Class IIa
EU 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

  • 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