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β-hCG Quantitative Test Kit (Time-Resolved FIA)

by Zhejiang Orient Gene Biotech Co., Ltd EUDAMED

Active European Union

Ref FAHCG-402a-DR10Model FAHCG-402a-DR10, FDHCG-402a-DR10LH, FDHCG-402a-DR10HG, FAHCG-402a-DR, FDHCG-402a-DRLH, FDHCG-402a-DRHG

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69509960FAHCG-402a-DRAR Basic UDI-DIDate21 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • 6188440TD05 Issued

    Technical documentation EU IVDR

    Notified body
    Notified body 0344
    Issued
    12 Jan 2026
    Expires
    1 Jan 2031
  • 6188440CE01 Supplemented

    Quality management system EU IVDR

    Notified body
    Notified body 0344
    Issued
    1 Sep 2026
    Expires
    1 Apr 2030
    Reason
    Add device or group

Specification

EUDAMED

Model / Reference
FAHCG-402a-DR10, FDHCG-402a-DR10LH, FDHCG-402a-DR10HG, FAHCG-402a-DR, FDHCG-402a-DRLH, FDHCG-402a-DRHG
Primary DI / UDI-DI
06950996003926
Basic UDI-DI
69509960FAHCG-402a-DRAR
Direct Marketing DI
06950996003926
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class B
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.

See all devices from Zhejiang Orient Gene Biotech Co., Ltd. →

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