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Hemoglobin A1c Test Kit (Immunofluorescence Method)

by Jiangsu Konsung Medical Technology Co., Ltd. China EUDAMED

Ref MHBAC-402F-25 EMDN W0102060199

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975132461910 Basic UDI-DIDate13 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Hemoglobin A1c Test Kit (Immunofluorescence Method)
Model / Reference
MHBAC-402F-25
Primary DI / UDI-DI
06975132461910
Basic UDI-DI
B-06975132461910
EMDN Code
W0102060199 Diabetes assays - other
Device Class
Class IVD General
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000004533
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Jiangsu Konsung Medical Technology Co., Ltd.

See all devices from Jiangsu Konsung Medical Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 79a89d37-cb51-4a02-9647-599b1efb50b3 61 fields · synced 24 Oct 2026