ZENFluxion

by Zylox-Tonbridge Medical Technology Co., Ltd. 227 variants

Ref ZY130020010018A

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-06971971819400 Basic UDI-DI 06971971819400UDI-DI	Date22 Apr 2022Registered	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Withdrawn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: Drug-coated PTA Balloon Catheter
Model / Reference: ZY130020010018A

Primary DI / UDI-DI: 06971971819400
Basic UDI-DI: B-06971971819400
EMDN Code: C010402020101 PTA balloon dilatation catheters

Device Class: Class III
EU market of registration: Italy

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
Administering Medicine
Incorporates Medicinal Product

Other properties (8)

Implantable: No
Reusable: No
Contains Latex: No
Reprocessed: No
Human-derived: No
Human Tissues: No
Animal Tissues: No
Measuring Function: No