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Hemoglobin Analyzer

by Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. China EUDAMED

Ref 5800Model H7-2

EMDN W02020699

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06934822535133 Basic UDI-DIDate21 Jul 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Hemoglobin Analyzer
Model / Reference
H7-2, 5800
Primary DI / UDI-DI
06934822535133
Basic UDI-DI
B-06934822535133
EMDN Code
W02020699 Rapid test hematology / histology / cytology instruments - other
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000016839
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd.

See all devices from Jiangsu Konsung Bio-Medical Science And Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Near-Patient Testing
  • Professional Testing
  • Surgical Instrument
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No

Sources (1)

  • EUDAMED 5d864b9a-f77b-4edb-97fa-bd8a16f07ec2 61 fields · synced 22 Oct 2026