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Single-use Balloon Dilatation Catheter

by Leo Medical Co., Ltd. 39 variants

Ref KZ1030E1, KZ1855G3, KZ1280F3, KZ0830H1, KZ0880H3, KZ2055G1, KZ1855H3, KZ0430E0, KZ0630H0, KZ0830H0, KZ1080F1, KZ0430H1, KZ0880F1, KZ1855H0, KZ1255G3, KZ0655H0, KZ0680H0, KZ1880F0, KZ1280H3, KZ1555H3, KZ1230H1, KZ2080F0, KZ1555H1, KZ1580F3, KZ0880H0, KZ1880H0, KZ0830E1, KZ0855H3, KZ0430E1, KZ1555G1, KZ1855G0, KZ1055G1, KZ0855G3, KZ0855H1, KZ1055G3, KZ1555G3, KZ1880F1, KZ1230H3, KZ1030H3, KZ0655G1, KZ1280H1, KZ0630H1, KZ2055G0, KZ0630H3, KZ0655H1, KZ1080H1, KZ1030E3, KZ1030H0, KZ1230E3, KZ0880F0Model KZ0430H0

Active European Union

CE MDR

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69236465L04YU Basic UDI-DI Date20 Feb 2025RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
Single-use Balloon Dilatation Catheter
Model / Reference
KZ0430H0, KZ1030E1, KZ1855G3, KZ1280F3, KZ0830H1, KZ0880H3, KZ2055G1, KZ1855H3, KZ0430E0, KZ0630H0, KZ0830H0, KZ1080F1, KZ0430H1, KZ0880F1, KZ1855H0, KZ1255G3, KZ0655H0, KZ0680H0, KZ1880F0, KZ1280H3, KZ1555H3, KZ1230H1, KZ2080F0, KZ1555H1, KZ1580F3, KZ0880H0, KZ1880H0, KZ0830E1, KZ0855H3, KZ0430E1, KZ1555G1, KZ1855G0, KZ1055G1, KZ0855G3, KZ0855H1, KZ1055G3, KZ1555G3, KZ1880F1, KZ1230H3, KZ1030H3, KZ0655G1, KZ1280H1, KZ0630H1, KZ2055G0, KZ0630H3, KZ0655H1, KZ1080H1, KZ1030E3, KZ1030H0, KZ1230E3, KZ0880F0
Primary DI / UDI-DI
06923646504500, 06941112337124, 06941112337179, 06923646594464, 06941112337353, 06923646504593, 06941112337322, 06923646504012, 06923646594334, 06923646594341, 06923646504623, 06923646594440, 06923646504616, 06923646504302, 06941112337100, 06923646504258, 06923646540621, 06923646504128, 06941112337377, 06941112337315, 06923646594488, 06923646504135, 06923646504715, 06941112337186, 06923646540690, 06923646540966, 06923646504494, 06941112337285, 06923646504470, 06923646504579, 06923646504432, 06923646504555, 06941112337087, 06923646594327, 06923646504685, 06941112337094, 06941112337117, 06923646504654, 06941112337254, 06941112337247, 06923646504531, 06923646543301, 06923646594457, 06923646504449, 06941112337223, 06923646504678, 06923646543141, 06941112337049, 06923646594358, 06941112337056, 06923646504081
Basic UDI-DI
69236465L04YU
Direct Marketing DI
06923646504500
06941112337124
06941112337179
06923646594464
06941112337353
06923646504593
06941112337322
06923646504012
06923646594334
06923646594341
06923646504623
06923646594440
06923646504616
06923646504302
06941112337100
06923646504258
06923646540621
06923646504128
06941112337377
06941112337315
06923646594488
06923646504135
06923646504715
06941112337186
06923646540690
06923646540966
06923646504494
06941112337285
06923646504470
06923646504579
06923646504432
06923646504555
06941112337087
06923646594327
06923646504685
06941112337094
06941112337117
06923646504654
06941112337254
06941112337247
06923646504531
06923646543301
06923646594457
06923646504449
06941112337223
06923646504678
06923646543141
06941112337049
06923646594358
06941112337056
06923646504081
EMDN Code
G03010199 Gastrointestinal endoscopy, balloon catheters - other
Device Class
Class IIa
EU market of registration
France
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000012017
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Leo Medical Co., Ltd.

See all devices from Leo Medical Co., Ltd. →

Properties

  • Sterile

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No