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Sphincterotome

by Leo Medical Co., Ltd. China EUDAMED

Ref ST0420N

EMDN G03040299

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69236465L05YW Basic UDI-DIDate16 Dec 2024RegisteredStatusActive

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
Sphincterotome
Model / Reference
ST0420N
Primary DI / UDI-DI
06923646505217
Basic UDI-DI
69236465L05YW
Direct Marketing DI
06923646505217
EMDN Code
G03040299 Papillotomes / sphincterotomes - other
Device Class
Class IIb
Market of Registration
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 & 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 30b32e2b-4aba-45b4-a90a-de1a9278ed0b 61 fields · synced 22 Oct 2026