ZENFlow

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

Ref ZW075035015035B

Active European Union

CE MDD

Valid until

Not listed

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

Region	Authorization	Number	Date	Status
European Union	CE/MDD	NumberB-06970596420466 Basic UDI-DI 06970596420466UDI-DI	Date21 Oct 2021Registered	StatusActive

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

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDD Active

Specification

EUDAMED

Device Name: PTA Balloon Catheter
Model / Reference: ZW075035015035B

Primary DI / UDI-DI: 06970596420466
Basic UDI-DI: B-06970596420466
EMDN Code: C010402020101 PTA balloon dilatation catheters

Device Class: Class IIa
EU market of registration: Poland

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.

Zenflow

Class IIa
ZENFluxion

Class III
ZENFlex Pro

Class III
Zenflow

Class IIa
ZENFlow

Class IIa
ZENFlow

Class IIa

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

Properties

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