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HbA1c Quantitative Test Kit (Time-Resolved FIA)

by Zhejiang Orient Gene Biotech Co., Ltd 3 variants

Ref FIHBA-402a-DRModel FIHBA-402a-DR10, FIHBA-402a-DR10LH, FIHBA-402a-DR10HG, FIHBA-402a-DR, FIHBA-402a-DRLH, FIHBA-402a-DRHG

Active European Union

CE IVDR

Valid until

1 Apr 2030

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number6188440CE01 Date1 Sep 2026IssuedStatusActive expires 1 Apr 2030

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 6188440TD10 Active

    Technical documentation EU IVDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    1 May 2026
    Expires
    1 May 2031
  • 6188440CE01 Active Supplemented

    Quality management system EU IVDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    1 Sep 2026
    Expires
    1 Apr 2030
    Reason
    Add device or group

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Model / Reference
FIHBA-402a-DR10, FIHBA-402a-DR10LH, FIHBA-402a-DR10HG, FIHBA-402a-DR, FIHBA-402a-DRLH, FIHBA-402a-DRHG
Primary DI / UDI-DI
06950996003964
Basic UDI-DI
69509960FIHBA-402a-DRES
Direct Marketing DI
06950996003964
EMDN Code
W0102160102 Glycosylated/glycated haemoglobin (ic) rt & poc
Device Class
Class C
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000017965
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Zhejiang Orient Gene Biotech Co., Ltd.

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Properties

  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No