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ONE STEP hCG PREGNANCY TEST

by Qingdao AIBO Diagnostic Co., LTD China EUDAMED

Ref midstream 12test

EMDN W0102050206

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06970871280068 Basic UDI-DIDate22 Jul 2024RegisteredStatusActive

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 22 Oct 2026

Model / Reference
midstream 12test
Primary DI / UDI-DI
06970871280068
Basic UDI-DI
B-06970871280068
EMDN Code
W0102050206 B- human chorionic gonadotropin (incl. subunit)
Device Class
Class IVD devices for self-testing
Market of Registration
Germany

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
  • Self Testing
  • Surgical Instrument
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No

Sources (1)

  • EUDAMED 6b121cd9-9f55-4a8d-a8ef-550dacbf3a8c 61 fields · synced 22 Oct 2026