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Latex Foley Catheters for Single Use

by Haiyan Kangyuan Medical Instrument Co., Ltd. China EUDAMED

Ref / EMDN U020299

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6948097019RJGLK Basic UDI-DIDate29 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 6122159CE01 Supplemented

    Quality management system EU MDR

    Notified body
    Notified body 0344
    Issued
    10 Apr 2025
    Expires
    1 Feb 2028
    Reason
    Add device or group

Specification

EUDAMED · synced 25 Oct 2026

Device Name
Latex Foley Catheters for Single Use
Model / Reference
/
Primary DI / UDI-DI
06948097052066
Basic UDI-DI
6948097019RJGLK
EMDN Code
U020299 Ureteral catheters with balloon - other
Device Class
Class IIb
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000001532
Authorised representative
Eunitor GmbH DE-AR-000005081

Other devices from Haiyan Kangyuan Medical Instrument Co., Ltd.

See all devices from Haiyan Kangyuan Medical Instrument Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 06948097052066|6948097019RJGLK 61 fields · synced 25 Oct 2026