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One Step LH ovulation Test

by Qingdao AIBO Diagnostic Co., LTD China EUDAMED

Ref midstream 5tests

EMDN W0102050105

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06970871281812 Basic UDI-DIDate15 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 24 Oct 2026

Model / Reference
midstream 5tests
Primary DI / UDI-DI
06970871281812
Basic UDI-DI
B-06970871281812
EMDN Code
W0102050105 Luteinising hormone
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
  • 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 c1452401-fe7d-4075-b65c-4c9f358970ea 61 fields · synced 24 Oct 2026