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ZENFlex Pro

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

Ref ZX05120125A

EMDN P0704020203

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06971971816577 Basic UDI-DIDate16 Apr 2022RegisteredStatusActive

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 22 Oct 2026

Device Name
Peripheral Drug-eluting Stent System
Model / Reference
ZX05120125A
Primary DI / UDI-DI
06971971816577
Basic UDI-DI
B-06971971816577
EMDN Code
P0704020203 Peripheral vascular drug eluting stents (des)
Device Class
Class III
Market of Registration
Poland

Manufacturer details

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

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Implantable
  • Administering Medicine
  • Incorporates Medicinal Product
Other properties (7)
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Measuring Function: No

Sources (1)

  • EUDAMED c4b358bb-0005-45bc-a04c-bee60d485f32 61 fields · synced 22 Oct 2026