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andorate® 2-piece Valve Kit

by GA Health Company Limited EUDAMED

Active European Union

Ref GAR037C

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number489710695101004CP8 Basic UDI-DIDate25 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
2-piece Valve Kit
Model / Reference
GAR037C
Primary DI / UDI-DI
04897106959037
Basic UDI-DI
489710695101004CP8
EMDN Code
G030899 Instruments for gastro-intestinal endoscopy and eco-endoscopy, single-use - other
Device Class
Class I
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
HK-MF-000019784
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Ga Health Company Limited

See all devices from Ga Health Company Limited →

Properties

  • 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