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Silicone Foley Catheters with Temperature probe for Single Use

by Haiyan Kangyuan Medical Instrument Co., Ltd. 19 variants

Ref /

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06948097052714 Basic UDI-DI 06948097052714UDI-DIDate30 Jul 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  • Withdrawn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

Device Name
Silicone Foley Catheters with Temperature probe for Single Use
Model / Reference
/
Primary DI / UDI-DI
06948097052714
Basic UDI-DI
B-06948097052714
EMDN Code
U0103 Urethral prostatic and bladder catheters with temperature sensors
Device Class
Class IIb
EU 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

  • 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