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HbChek

by Biosense Technologies Private Limited. India EUDAMED

Ref FG00053Model Hemoglobin Microcuvette

EMDN W0103010201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number8908015864HBCHEKSTRIPCD Basic UDI-DIDate16 Mar 2026RegisteredStatusActive

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 Microcuvette / Test Strips - A Reagent less Specimen Receptacle
Model / Reference
Hemoglobin Microcuvette, FG00053
Primary DI / UDI-DI
08908015864100
Basic UDI-DI
8908015864HBCHEKSTRIPCD
EMDN Code
W0103010201 Haemoglobin determinations (total hb)
Device Class
Class A
Market of Registration
Estonia

Manufacturer details

EUDAMED SRN
IN-MF-000052180
Authorised representative
MD&D Alliance GmbH DE-AR-000045389

Other devices from Biosense Technologies Private Limited.

Properties & raw data

Show properties, registry sources and raw records
  • Professional Testing
Other properties (10)
  • 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
  • New Device: No

Sources (1)

  • EUDAMED 4e12821c-20dd-4018-b75c-dd1af0949890 61 fields · synced 22 Oct 2026