Skip to content

Zenflow

by Zylox-Tonbridge Medical Technology Co., Ltd. 744 variants

Ref ZWH075070018035B

Active European Union

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06971971811213 Basic UDI-DI 06971971811213UDI-DIDate8 Nov 2021RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device name
HP PTA Balloon Catheter
Model / reference
ZWH075070018035B
Primary DI / UDI-DI
06971971811213
Basic UDI-DI
B-06971971811213
EMDN code
C010402020101 PTA balloon dilatation catheters
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU 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

  • Supplied sterile

Other properties (11)

  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No