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Disposable Endoscopy Dilation Balloon

by Alton (Shanghai) Medical Instruments Co., Ltd. China EUDAMED

Ref AF-D0718BC0660FModel Disposable Endoscopy Dilation Balloon

EMDN G03010199

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697067138BC044AN Basic UDI-DIDate30 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
Disposable Endoscopy Dilation Balloon, AF-D0718BC0660F
Primary DI / UDI-DI
06942127888656
Basic UDI-DI
697067138BC044AN
EMDN Code
G03010199 Gastrointestinal endoscopy, balloon catheters - other
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000012832
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Alton (Shanghai) Medical Instruments Co., Ltd.

See all devices from Alton (Shanghai) Medical Instruments 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 06942127888656|697067138BC044AN 61 fields · synced 24 Oct 2026