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ZENFlex

by Zylox-Tonbridge Medical Technology Co., Ltd. 46 variants

Ref ZX07120080B, ZX05100125B, ZX05100080A, ZX07100080B, ZX07060125A, ZX06020125B, ZX05040080B, ZX07020125A, ZX07020125B, ZX07030080B, ZX07040080B, ZX06060125B, ZX06020125A, ZX06040125B, ZX04060125B, ZX06100080B, ZX07020080A, ZX07060080A, ZX08060125B, ZX08100125B, ZX08150125B, ZX06120080B, ZX09150080B, ZX05060125A, ZX05150125B, ZX05020080A, ZX05080125A, ZX04030125B, ZX05080125B, ZX08020080B, ZX09040125B, ZX07060125B, ZX05150125A, ZX05150080A, ZX04040080B, ZX07030125A, ZX08040125B, ZX07030080A, ZX07120125A, ZX09060080B, ZX08080125B, ZX05120125B, ZX07040125B, ZX05020125A, ZX06120080A, ZX08020125B, ZX06040125A, ZX07040080A, ZX08150080B, ZX09150125B, ZX07150125A

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-06970596426284 Basic UDI-DI Date8 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  • Withdrawn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

Trade Name
ZENFlex
ZENFlex Pro
Device Name
Peripheral Stent System
Peripheral Drug-eluting Stent System
Model / Reference
ZX07120080B, ZX05100125B, ZX05100080A, ZX07100080B, ZX07060125A, ZX06020125B, ZX05040080B, ZX07020125A, ZX07020125B, ZX07030080B, ZX07040080B, ZX06060125B, ZX06020125A, ZX06040125B, ZX04060125B, ZX06100080B, ZX07020080A, ZX07060080A, ZX08060125B, ZX08100125B, ZX08150125B, ZX06120080B, ZX09150080B, ZX05060125A, ZX05150125B, ZX05020080A, ZX05080125A, ZX04030125B, ZX05080125B, ZX08020080B, ZX09040125B, ZX07060125B, ZX05150125A, ZX05150080A, ZX04040080B, ZX07030125A, ZX08040125B, ZX07030080A, ZX07120125A, ZX09060080B, ZX08080125B, ZX05120125B, ZX07040125B, ZX05020125A, ZX06120080A, ZX08020125B, ZX06040125A, ZX07040080A, ZX08150080B, ZX09150125B, ZX07150125A
Primary DI / UDI-DI
06970596426284, 06970596426574, 06971971816324, 06970596426277, 06971971816706, 06970596426604, 06970596426086, 06971971816676, 06970596426680, 06970596426239, 06970596426246, 06970596426635, 06971971816591, 06970596426628, 06970596426499, 06970596426192, 06971971816430, 06971971816461, 06970596426796, 06970596426819, 06970596426833, 06970596426208, 06970596426451, 06971971816539, 06970596426598, 06971971816270, 06971971816553, 06970596426475, 06970596426567, 06970596426307, 06970596426864, 06970596426710, 06971971816584, 06971971816348, 06970596426024, 06971971816683, 06970596426789, 06971971816447, 06971971816737, 06970596426413, 06970596426802, 06970596426581, 06970596426703, 06971971816515, 06971971816416, 06970596426765, 06971971816614, 06971971816454, 06970596426376, 06970596426918, 06971971816744
Basic UDI-DI
B-06970596426284, B-06970596426574, B-06971971816324, B-06970596426277, B-06971971816706, B-06970596426604, B-06970596426086, B-06971971816676, B-06970596426680, B-06970596426239, B-06970596426246, B-06970596426635, B-06971971816591, B-06970596426628, B-06970596426499, B-06970596426192, B-06971971816430, B-06971971816461, B-06970596426796, B-06970596426819, B-06970596426833, B-06970596426208, B-06970596426451, B-06971971816539, B-06970596426598, B-06971971816270, B-06971971816553, B-06970596426475, B-06970596426567, B-06970596426307, B-06970596426864, B-06970596426710, B-06971971816584, B-06971971816348, B-06970596426024, B-06971971816683, B-06970596426789, B-06971971816447, B-06971971816737, B-06970596426413, B-06970596426802, B-06970596426581, B-06970596426703, B-06971971816515, B-06971971816416, B-06970596426765, B-06971971816614, B-06971971816454, B-06970596426376, B-06970596426918, B-06971971816744
EMDN Code
P070402020102, P0704020203
Device Class
Class IIb
Class III
EU market of registration
France
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.

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

Properties

  • Sterile
  • Implantable
  • Administering Medicine NoEUDAMEDYesEUDAMED
  • Incorporates Medicinal Product NoEUDAMEDYesEUDAMED

Other properties (7)

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