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by Zylox-Tonbridge Medical Technology Co., Ltd. China EUDAMED

Ref ZWH040090003035B

EMDN C010402020101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06971971811602 Basic UDI-DIDate10 Nov 2021RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
HP PTA Balloon Catheter
Model / Reference
ZWH040090003035B
Primary DI / UDI-DI
06971971811602
Basic UDI-DI
B-06971971811602
EMDN Code
C010402020101 PTA balloon dilatation catheters
Device Class
Class IIa
Market of Registration
Czechia

Manufacturer details

EUDAMED SRN
CN-MF-000010626
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Related devices

Category: Peripheral angioplasty balloon catheter, basic

Other devices from Zylox-Tonbridge Medical Technology Co., Ltd.

See all devices from Zylox-Tonbridge Medical Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED c2e0c213-2225-4ed7-b27e-6559a66240df 61 fields · synced 24 Oct 2026