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LH Ovulation Rapid Test

by Healgen Scientific Limited Liability Company United States EUDAMED

Ref GALH-101a-25T EMDN W0102160304

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-GALH-101a-25THGS2 Basic UDI-DIDate23 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
GALH-101a-25T
Primary DI / UDI-DI
D-GALH-101a-25THGS2
Basic UDI-DI
B-GALH-101a-25THGS2
EMDN Code
W0102160304 Lh - rt & poc
Device Class
Class IVD devices for self-testing
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000018839
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Healgen Scientific Limited Liability Company

See all devices from Healgen Scientific Limited Liability Company →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Self Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED 7d018208-8bca-48a7-8c38-a34e0b6720e2 61 fields · synced 23 Oct 2026