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Single-use Balloon Dilatation Catheter

by Leo Medical Co., Ltd. China EUDAMED

Ref KZ0630L0Model KZ0430H0

EMDN G03010199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69236465L04YU Basic UDI-DIDate20 Feb 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Single-use Balloon Dilatation Catheter
Model / Reference
KZ0430H0, KZ0630L0
Primary DI / UDI-DI
06923646540584
Basic UDI-DI
69236465L04YU
Direct Marketing DI
06923646540584
EMDN Code
G03010199 Gastrointestinal endoscopy, balloon catheters - other
Device Class
Class IIa
Market of Registration
France

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 & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 7e23489f-276b-4d99-8338-223330889886 61 fields · synced 22 Oct 2026