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Total β-HCG Total β-Human Chorionic Gonadotropin (CLIA)

by Hangzhou Aichek Medical Technology Co., Ltd. FDA registration: China EUDAMED

Ref TB-HCG706-AE10Y, TB-HCG706-AE10N, TB-HCG706-AE20Y, TB-HCG706-AE20N EMDN W0102050206

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-TB-HCG706-AEN4 Basic UDI-DIDate7 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
TB-HCG706-AE10Y, TB-HCG706-AE10N, TB-HCG706-AE20Y, TB-HCG706-AE20N
Primary DI / UDI-DI
D-TB-HCG706-AEN4
Basic UDI-DI
B-TB-HCG706-AEN4
EMDN Code
W0102050206 B- human chorionic gonadotropin (incl. subunit)
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000028093
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from Hangzhou Aichek Medical Technology Co., Ltd.

See all devices from Hangzhou Aichek Medical Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • 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

Sources (1)

  • EUDAMED 39b0fdc6-4581-4dee-a326-6f3a90855684 61 fields · synced 24 Oct 2026