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Sterile Urethral Catheters for Single Use(balloon)

by Jiangxi Yikang Medical Instrument Group Co., Ltd. 84 variants

Ref 6485Model 2-Way female reinforced

Withdrawn Withdrawn in European Union. No longer placed on the EU market.

Was authorized under CE MDR, withdrawn

Ended

Withdrawn

Date not published (CE MDR)

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69492301RJDNG05VU Basic UDI-DI 06949230164851UDI-DIDate27 May 2026RegisteredStatusWithdrawn No longer placed on the EU market

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  • Withdrawn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European Union — CE/MDR Withdrawn

Specification

EUDAMED

Model / Reference
2-Way female reinforced, 6485
Primary DI / UDI-DI
06949230164851
Basic UDI-DI
69492301RJDNG05VU
EMDN Code
U010202 Urethral prostatic and bladder catheters, couvelaire, with balloon
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
CN-MF-000030129
Authorised representative
phoenix Medtech GmbH DE-AR-000007996

Other devices from Jiangxi Yikang Medical Instrument Group Co., Ltd.

See all devices from Jiangxi Yikang Medical Instrument Group 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