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Hematology Analyzer

by Edan Instruments, Inc. China EUDAMED

Ref H30 Pro, H30 Pro

EMDN W0202010201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06944413814233 Basic UDI-DIDate9 Jan 2026RegisteredStatusActive
European UnionCE/IVDD NumberB-06944413814233 Basic UDI-DIDate9 Jan 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
H30 Pro, H30 Pro
Primary DI / UDI-DI
06944413814233
Basic UDI-DI
B-06944413814233, 69444138H30ProSP9
EMDN Code
W0202010201 Automated 3 part hematology analysers
Device Class
Class IVD General
Class B
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000009957
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Edan Instruments, Inc.

See all devices from Edan Instruments, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
  • Surgical Instrument
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • New Device: No

Sources (2)

  • EUDAMED afe4db77-2283-4f19-8485-a56de299b37e 61 fields · synced 22 Oct 2026
  • EUDAMED a50cbdb9-3d1c-4d60-b13d-bc0628e789ab 61 fields · synced 19 May 2026