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Glycated Hemoglobin Chemiluminescence Immunoassay Kit

by Nanjing RealMind Biotech Co., Ltd. 2 variants

Ref 100tests/kit, 50tests/kitModel Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 100tests/kit, Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 50tests/kit, Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 100tests/kit, Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 50tests/kit, Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 50tests/kit

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06972719601431 Basic UDI-DI Date23 May 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Glycated Hemoglobin Chemiluminescence Immunoassay Kit
Model / Reference
Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 100tests/kit, 100tests/kit, Reagents (include Calibrator 1x1mL/bottle and Control 2x1mL/bottle) 50tests/kit, 50tests/kit, Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 100tests/kit, Reagents (include Calibrator 1x1mL/bottle and Control 1x1mL/bottle) 50tests/kit, Reagents (include Calibrator 2x1mL/bottle and Control 2x1mL/bottle) 50tests/kit
Primary DI / UDI-DI
06972719601431, 06972719603190, 06972719605194, 06972719601585, 06972719605200
Basic UDI-DI
B-06972719601431, B-06972719603190, B-06972719605194, B-06972719601585, B-06972719605200
EMDN Code
W0102060109 Glycosylated/glycated haemoglobin (ic)
Device Class
Class IVD General
EU market of registration
Hungary

Manufacturer details

EUDAMED SRN
CN-MF-000024838
Authorised representative
Lotus NL B.V. NL-AR-000000121

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Properties

  • Reagent

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No