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One Step LH Ovulation Test

by AccuBioTech Co., Ltd. 3 variants

Ref ABT-FT-A3Model Strip

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-ABT-FT-A3ZW Basic UDI-DI D-ABT-FT-A3ZWUDI-DIDate28 Jul 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD Active

Specification

EUDAMED

Model / Reference
Strip, ABT-FT-A3
Primary DI / UDI-DI
D-ABT-FT-A3ZW
Basic UDI-DI
B-ABT-FT-A3ZW
EMDN Code
W0102160304 Lh - rt & poc
Device Class
Class IVD devices for self-testing
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000025172
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from AccuBioTech Co., Ltd.

See all devices from AccuBioTech Co., Ltd. →

Properties

  • 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