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Infusion Pump

by HEDY Medical Device Co., Ltd. China EUDAMED

Ref 06970021438028Model i5

EMDN Z12030301

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-06970021438028L9 Basic UDI-DIDate2 Nov 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/MDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
i5, 06970021438028
Primary DI / UDI-DI
D-06970021438028L9
Basic UDI-DI
B-06970021438028L9
EMDN Code
Z12030301 Infusion pumps
Device Class
Class IIb
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
CN-MF-000030128
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from HEDY Medical Device Co., Ltd.

See all devices from HEDY Medical Device Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
Other properties (11)
  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 7c287750-1738-43d5-b61e-20cbbc612919 61 fields · synced 22 Oct 2026