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Sphincterotome

by Leo Medical Co., Ltd. China EUDAMED

Ref RST0725RModel RST0420R

EMDN G03040202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number69411123L22TG Basic UDI-DIDate2 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Sphincterotome
Model / Reference
RST0420R, RST0725R
Primary DI / UDI-DI
06941112309664
Basic UDI-DI
69411123L22TG
Direct Marketing DI
06941112309664
EMDN Code
G03040202 Papillotomes / sphincterotomes, triple (or more) lumen
Device Class
Class IIb
Market of Registration
Poland

Manufacturer details

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

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 1f9994f7-6757-4328-a5b7-ea09e8479783 61 fields · synced 23 Oct 2026