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3-stage Dilation Balloon Catheter

by Jiangsu Changmei Medtech Co., Ltd. EUDAMED

Active European Union

Ref TB-28U-C55

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06923558507958 Basic UDI-DIDate26 May 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  • Withdrawn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

Device Name
3-stage Dilation Balloon Catheter
Model / Reference
TB-28U-C55
Primary DI / UDI-DI
06923558507958
Market of Registration
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000012609
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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