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Glycosylated hemoglobin A1c (HbA1c) Rapid Test Kit(Fluorescence Immunochromatographic Assay)

by Diasia Biomedical Technology Co., Ltd. 2 variants

Ref R331020, R331021, R331023, 5257C4X025Model 10 Tests/kit, 25 Tests/kit, 100 Tests/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-06973316741919 Basic UDI-DI Date10 Dec 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  • Withdrawn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

Trade Name
Hemoglobin A1c (HbA1c) Rapid Test Kit (Fluorescence Immunochromatographic Assay)
Device Name
Glycosylated hemoglobin A1c (HbA1c) Rapid Test Kit(Fluorescence Immunochromatographic Assay)
Model / Reference
10 Tests/kit, R331020, 25 Tests/kit, R331021, 100 Tests/kit, R331023, 5257C4X025
Primary DI / UDI-DI
06973316741919, 06973316741926, 06973316741940, 06974464591401
Basic UDI-DI
B-06973316741919, B-06973316741926, B-06973316741940, B-06974464591401
EMDN Code
W0101060107, W0103010299
Device Class
Class IVD General
EU market of registration
Spain
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000010281
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Diasia Biomedical Technology Co., Ltd.

See all devices from Diasia Biomedical Technology Co., Ltd. →

Properties

  • Animal Tissues NoEUDAMEDYesEUDAMED
  • 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