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One Step Ovulation Test Cassette (Urine)

by Healgen Scientific Limited Liability Company

Ref GALH-102b, GALH-102a

Active European Union. Also listed in GUDID (US).

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

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

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-GALH-102bHGHX Basic UDI-DI Date9 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-GALH-102bHGHX UDI-DI Date12 Aug 2019ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/IVDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
One Step Ovulation Test Cassette (Urine) EUDAMED
Healgen GUDID
Generic Name
Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Model / Ref / Catalog
GALH-102b, GALH-102a
Primary DI / UDI-DI
D-GALH-102bHGHX EUDAMED
D-GALH-102aHGHS EUDAMED
00816490023555 GUDID
Basic UDI-DI
B-GALH-102bHGHX, B-GALH-102aHGHS
EMDN Code
W0102160304 Lh - rt & poc
GMDN Term
Luteinizing hormone (LH) IVD, kit, rapid ICT, clinical
Device Class
Class IVD General
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-GALH-102bHGHX
D-GALH-102aHGHS
GUDID
00816490023555

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

  • Single Use
  • Animal Tissues
  • Professional Testing
  • Prescription Use
  • Over-the-Counter
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (15)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Human Tissues: No
  • Microbial Substances: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No