Skip to content

Glycohemoglobin a 1C Reagent Kit

by Dirui Industrial Co., Ltd EUDAMED

Active European Union

Ref 3023248Model R1:2×15mL,R2:R2-A:1×0.5mL R2-B:1×9.5mL,Lyse:2×50mL,Diluent:7mL,Calibration sample: 5x1mL, Control: 2x1mL

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06942202213519 Basic UDI-DIDate11 May 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
R1:2×15mL, R2:R2-A:1×0.5mL R2-B:1×9.5mL, Lyse:2×50mL, Diluent:7mL, Calibration sample: 5x1mL, Control: 2x1mL, 3023248
Primary DI / UDI-DI
06942202213519
Basic UDI-DI
B-06942202213519
EMDN Code
W01010214 Glycosylated/glycated haemoglobin (cc)
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000001891
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Dirui Industrial Co., Ltd

See all devices from Dirui Industrial Co., Ltd →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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