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ZENFluxion

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

Ref ZY075040002035A, ZY150040008014A, ZY100070004035A, ZY180060008018A, ZY150040004014A, ZY180035008018A, ZY140025010014A, ZY075030008035A, ZY100040010014A, ZY140035010014A, ZY100030012035A, ZY140020008014A, ZY110030015035A, ZY100070006035A, ZY130060008018A, ZY075120004035A, ZY075050022035A, ZY045070006018A, ZY150050008014A, ZY130060022035A, ZY130030010014A, ZY075020002018A, ZY130040004014A, ZY075060008018A, Drug-coated PTA Balloon Catheter, ZY075090004018A, ZY110035015035A, ZY130040010014A, ZY100030002035A, ZY100050012014A, ZY110040012035A, ZY100100006035A, ZY075020015018A, ZY075040004018A, ZY110035002035A, ZY075060008035A, ZY130035010014A, ZY100030008014A, ZY075050004018A, ZY075035004035A, ZY150025022014A, ZY100070002035A, ZY110030006035A, ZY140050008014A, ZY110040002035A, ZY075040010018A, ZY130025006018A, ZY130050003014A, ZY150030004014A, ZY130070002035A, ZY075050012035AModel ZY130025022014A

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06970596425935 Basic UDI-DI Date25 Apr 2022RegisteredStatusActive

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  • Withdrawn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
Drug-coated PTA Balloon Catheter
Model / Reference
ZY075040002035A, ZY150040008014A, ZY100070004035A, ZY180060008018A, ZY150040004014A, ZY180035008018A, ZY140025010014A, ZY075030008035A, ZY100040010014A, ZY140035010014A, ZY100030012035A, ZY140020008014A, ZY110030015035A, ZY100070006035A, ZY130060008018A, ZY075120004035A, ZY075050022035A, ZY045070006018A, ZY150050008014A, ZY130060022035A, ZY130030010014A, ZY075020002018A, ZY130040004014A, ZY075060008018A, ZY130025022014A, Drug-coated PTA Balloon Catheter, ZY075090004018A, ZY110035015035A, ZY130040010014A, ZY100030002035A, ZY100050012014A, ZY110040012035A, ZY100100006035A, ZY075020015018A, ZY075040004018A, ZY110035002035A, ZY075060008035A, ZY130035010014A, ZY100030008014A, ZY075050004018A, ZY075035004035A, ZY150025022014A, ZY100070002035A, ZY110030006035A, ZY140050008014A, ZY110040002035A, ZY075040010018A, ZY130025006018A, ZY130050003014A, ZY150030004014A, ZY130070002035A, ZY075050012035A
Primary DI / UDI-DI
06970596425935, 06971971817482, 06974042970239, 06971971819363, 06971971817239, 06971971819257, 06971971817628, 06974042970659, 06971971817727, 06971971817703, 06974042971038, 06971971817314, 06974042971236, 06974042970543, 06971971819349, 06974042970321, 06974042971496, 06971971819042, 06971971817529, 06974042971540, 06971971817659, 06971971818373, 06971971817215, 06971971819332, 06971971818274, 06971971818861, 06974042971267, 06971971817734, 06970596425881, 06971971818038, 06974042971106, 06974042970628, 06971971819875, 06971971818663, 06970596425928, 06974042970789, 06971971817697, 06971971817376, 06971971818700, 06974042970093, 06971971818298, 06970596426994, 06974042970383, 06971971817512, 06970596425959, 06971971819516, 06971971818915, 06971971817000, 06971971817154, 06970596427038, 06974042971120
Basic UDI-DI
B-06970596425935, B-06971971817482, B-06974042970239, B-06971971819363, B-06971971817239, B-06971971819257, B-06971971817628, B-06974042970659, B-06971971817727, B-06971971817703, B-06974042971038, B-06971971817314, B-06974042971236, B-06974042970543, B-06971971819349, B-06974042970321, B-06974042971496, B-06971971819042, B-06971971817529, B-06974042971540, B-06971971817659, B-06971971818373, B-06971971817215, B-06971971819332, B-06971971818274, B-06971971818861, B-06974042971267, B-06971971817734, B-06970596425881, B-06971971818038, B-06974042971106, B-06974042970628, B-06971971819875, B-06971971818663, B-06970596425928, B-06974042970789, B-06971971817697, B-06971971817376, B-06971971818700, B-06974042970093, B-06971971818298, B-06970596426994, B-06974042970383, B-06971971817512, B-06970596425959, B-06971971819516, B-06971971818915, B-06971971817000, B-06971971817154, B-06970596427038, B-06974042971120
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

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

  • 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