Skip to content

Balloon Dilatation Catheter

by Hangzhou AGS MedTech Co., Ltd. China EUDAMED

Ref AG-5251-153018-20

EMDN G0301010101

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number695966495251000015H Basic UDI-DIDate2 Sep 2022RegisteredStatusActive

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
Balloon Dilatation Catheter
Model / Reference
AG-5251-153018-20
Primary DI / UDI-DI
06959664926543
Basic UDI-DI
695966495251000015H
EMDN Code
G0301010101 Oesophageal balloon catheters, low pressure
Device Class
Class IIa
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000011718
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Hangzhou AGS MedTech Co., Ltd.

See all devices from Hangzhou AGS MedTech Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Contains Latex
Other properties (11)
  • Implantable: No
  • Reusable: 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 0a6a795f-c6da-4f38-afea-fafc8e7ef152 61 fields · synced 23 Oct 2026