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Hemoglobin control

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

Ref Level LModel HBC-3A

EMDN W0103010504

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06934822535539 Basic UDI-DIDate18 Nov 2022RegisteredStatusActive

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 control
Model / Reference
HBC-3A, Level L
Primary DI / UDI-DI
06934822535539
Basic UDI-DI
B-06934822535539
EMDN Code
W0103010504 Haemoglobin controls
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
  • Professional Testing
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
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 2ab89d2f-f86d-42ed-bdb4-ded6bf4c18d5 61 fields · synced 22 Oct 2026