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Silicone Foley Catheters with Temperature probe for Single Use

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

Ref / EMDN U0103

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06948097052523 Basic UDI-DIDate24 Jul 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  • Withdrawn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

Device Name
Silicone Foley Catheters with Temperature probe for Single Use
Model / Reference
/
Primary DI / UDI-DI
06948097052523
Basic UDI-DI
B-06948097052523
EMDN Code
U0103 Urethral prostatic and bladder catheters with temperature sensors
Device Class
Class IIb
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000001532
Authorised representative
Lotus NL B.V. NL-AR-000000121

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
  • Measuring Function
Other properties (9)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 06948097052523|B-06948097052523 61 fields · synced 25 Oct 2026