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Glycosylated Hemoglobin (HbA1c) Assay Kits （HPLC）

by AILEX(Hunan)Medical Equipment Co., Ltd. 34 variants

Ref /Model Calibrator 1～2:1×1mL, Control 1～2：1×0.5mL, Calibrator 1～2:4×1mL, Calibrator 1～2:1×0.5mL, Eluent4: 800mL×1bag, Eluent2: 800mL×1bag, Hemolysis & Wash Solution:2L×1bottle, 500Tests, Control 1～2：4×0.5mL, Eluent1: 800mL ×10bags, Hemolysis & Wash Solution:2L×5bottles, Eluent3: 800mL ×10bags, Calibrator 1～2:1×4mL, Eluent4: 800mL ×10bags, Eluent3: 800mL×1bag, Eluent1: 800mL×1bag, Calibrator 1～2:4×4mL, 1500Tests, 2000Tests, 1000Tests

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975531321549 Basic UDI-DI Date9 Mar 2026RegisteredStatusActive

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  • Withdrawn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
Glycosylated Hemoglobin (HbA1c) Assay Kits （HPLC）
Model / Reference
Calibrator 1～2:1×1mL, /, Control 1～2：1×0.5mL, Calibrator 1～2:4×1mL, Calibrator 1～2:1×0.5mL, Eluent4: 800mL×1bag, Eluent2: 800mL×1bag, Hemolysis & Wash Solution:2L×1bottle, 500Tests, Control 1～2：4×0.5mL, Eluent1: 800mL ×10bags, Hemolysis & Wash Solution:2L×5bottles, Eluent3: 800mL ×10bags, Calibrator 1～2:1×4mL, Eluent4: 800mL ×10bags, Eluent3: 800mL×1bag, Eluent1: 800mL×1bag, Calibrator 1～2:4×4mL, 1500Tests, 2000Tests, 1000Tests
Primary DI / UDI-DI
06975531321549, 06975531323185, 06975531323154, 06975531322898, 06975531323031, 06975531321938, 06975531323055, 06975531321860, 06975531323079, 06975531323192, 06975531321402, 06975531322829, 06975531322836, 06975531322799, 06975531321440, 06975531321488, 06975531322959, 06975531323161, 06975531323048, 06975531321563, 06975531322782, 06975531321396, 06975531321570, 06975531321457, 06975531322911, 06975531321471, 06975531322867, 06975531322973, 06975531321495, 06975531322843, 06975531322997, 06975531322874, 06975531323086, 06975531321501, 06975531321884
Basic UDI-DI
B-06975531321549, B-06975531323185, B-06975531323154, B-06975531322898, B-06975531323031, B-06975531321938, B-06975531323055, B-06975531321860, B-06975531323079, B-06975531323192, B-06975531321402, B-06975531322829, B-06975531322836, B-06975531322799, B-06975531321440, B-06975531321488, B-06975531322959, B-06975531323161, B-06975531323048, B-06975531321563, B-06975531322782, B-06975531321396, B-06975531321570, B-06975531321457, B-06975531322911, B-06975531321471, B-06975531322867, B-06975531322973, B-06975531321495, B-06975531322843, B-06975531322997, B-06975531322874, B-06975531323086, B-06975531321501, B-06975531321884
EMDN Code
W01010214 Glycosylated/glycated haemoglobin (cc)
Device Class
Class IVD General
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000043377
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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Properties

  • Human Tissues YesEUDAMEDNoEUDAMED
  • Reagent
  • Professional Testing

Other properties (7)

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