Skip to content

Zenflow

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

Ref ZWH075080006035B

EMDN C010402020101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06971971811428 Basic UDI-DIDate8 Oct 2026RegisteredStatusActive

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 23 Oct 2026

Device Name
HP PTA Balloon Catheter
Model / Reference
ZWH075080006035B
Primary DI / UDI-DI
06971971811428
Basic UDI-DI
B-06971971811428
EMDN Code
C010402020101 PTA balloon dilatation catheters
Device Class
Class IIa
Market of Registration
Denmark

Manufacturer details

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

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 06971971811428|B-06971971811428 61 fields · synced 23 Oct 2026