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Eveline Ovulation Test Kit

by iXensor Co., Ltd. Taiwan EUDAMED

Ref 1629Model WHM-A01 EMDN W0102160304

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-04719872951629 Basic UDI-DIDate8 Nov 2022RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Eveline Ovulation Test Kit (10pcs/pack)
Model / Reference
WHM-A01, 1629
Primary DI / UDI-DI
04719872951629
Basic UDI-DI
B-04719872951629
EMDN Code
W0102160304 Lh - rt & poc
Device Class
Class IVD devices for self-testing
Market of Registration
Hungary

Manufacturer details

EUDAMED SRN
TW-MF-000026279
Authorised representative
MDSS GmbH DE-AR-000005430

Other devices from iXensor Co., Ltd.

See all devices from iXensor Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Self Testing
  • Near-Patient Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 4d878dea-0e9c-4ab2-8ae6-fa29dc45dcd7 61 fields · synced 22 Oct 2026