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LH Ovulation Rapid Test

by Zhejiang Orient Gene Biotech Co., Ltd China EUDAMED

Ref GALH-102b-1TModel GALH-102a-1T EMDN W0102160304

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-GALH-102a-1TF5 Basic UDI-DIDate21 Apr 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  • Withdrawn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 22 Oct 2026

Model / Reference
GALH-102a-1T, GALH-102b-1T
Primary DI / UDI-DI
D-GALH-102a-1TF5, D-GALH-102b-1TFC
Basic UDI-DI
B-GALH-102a-1TF5, B-GALH-102b-1TFC
EMDN Code
W0102160304 Lh - rt & poc
Device Class
Class IVD devices for self-testing
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000017965
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Zhejiang Orient Gene Biotech Co., Ltd.

See all devices from Zhejiang Orient Gene Biotech Co., Ltd. →

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 (2)

  • EUDAMED a46933c3-f546-4809-8a8e-fd1098683f2e 61 fields · synced 22 Oct 2026
  • EUDAMED D-GALH-102B-1TFC|B-GALH-102B-1TFC 61 fields · synced 19 May 2026