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Disposable Intermittent Catheter

by Hangzhou Yiguoren Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref TS-B8FrModel TN、TC、TS

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697041335YGR1902EUAY Basic UDI-DIDate20 Dec 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
TN、TC、TS, TS-B8Fr
Primary DI / UDI-DI
06970413352345
Basic UDI-DI
697041335YGR1902EUAY
EMDN Code
U01010502 Nelaton catheters, non self-lubricating
Device Class
Class I
Market of Registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000003616
Authorised representative
BioDomi GmbH DE-AR-000016611

Other devices from Hangzhou Yiguoren Biotechnology Co., Ltd.

See all devices from Hangzhou Yiguoren Biotechnology Co., Ltd. →

Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: 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