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One Step Pregnancy Test Strip (Urine)

by Healgen Scientific Limited Liability Company EUDAMEDGUDID

Active European Union

Ref GAHCG-101m, GAHCG-101a, GAHCG-101d

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD EUDAMED NumberB-GAHCG-101mHGMG Basic UDI-DIDate9 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD-GAHCG-101mHGMG UDI-DIDate31 Dec 2016ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

Certificates

0 certificates · EUDAMED

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

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
One Step Pregnancy Test Strip (Urine) EUDAMED
Healgen GUDID
Generic Name
Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing
Model / Ref / Catalog
GAHCG-101m, GAHCG-101a, GAHCG-101d
Primary DI / UDI-DI
D-GAHCG-101mHGMG EUDAMED
D-GAHCG-101aHGKL EUDAMED
D-GAHCG-101dHGL3 EUDAMED
00816490021124 GUDID
Basic UDI-DI
B-GAHCG-101mHGMG, B-GAHCG-101aHGKL, B-GAHCG-101dHGL3
FDA Product Code
LCX
EMDN Code
W0102160302 Hcg - rt & poc
GMDN Term
Total human chorionic gonadotropin IVD, kit, rapid ICT, self-testing
Device Class
Class IVD General EUDAMED
Class II GUDID
Regulation Number
862.1155
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D-GAHCG-101mHGMG
D-GAHCG-101aHGKL
D-GAHCG-101dHGL3
GUDID
00816490021124
Device ClassEUDAMED
Class IVD General
GUDID
Class II

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