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Free Human Chorionic Gonadotropin β Subunit（Free-β-HCG）Detection Kit（Magnetic Solid Phase Chemiluminescent Immunoassay)

by Biobase Diagnostic Technology (Shandong) Co., Ltd. 3 variants

Ref 100 Tests/kit（DR1123-2）Model 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974969982063 Basic UDI-DI 06974969982063UDI-DIDate5 May 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  • Withdrawn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

Model / Reference
100 Tests/kit, 100 Tests/kit（DR1123-2）
Primary DI / UDI-DI
06974969982063
Basic UDI-DI
B-06974969982063
EMDN Code
W0102050213 Free beta hcg (prenatal screening)
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000025964
Authorised representative
Luxus Lebenswelt GmbH DE-AR-000005110

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Properties

  • Reagent
  • Professional Testing

Other properties (8)

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