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One Step hCG Pregnancy Test

by Qingdao AIBO Diagnostic Co., LTD China EUDAMED

Ref 010902

EMDN W0102050206

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06970871282055 Basic UDI-DIDate11 Sep 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
010902
Primary DI / UDI-DI
06970871282055
Basic UDI-DI
B-06970871282055
EMDN Code
W0102050206 B- human chorionic gonadotropin (incl. subunit)
Device Class
Class IVD devices for self-testing
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000041127
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Qingdao AIBO Diagnostic Co., LTD

See all devices from Qingdao AIBO Diagnostic Co., LTD →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Self Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED cc7a52df-b4c8-47c6-b3f6-e44e4d14e12b 61 fields · synced 23 Oct 2026