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hCG Pregnancy Rapid Test Kit (Urine)

by Hangzhou Frenovo Biotech Co., Ltd. 7 variants

Ref CH190GH090GA5T

Active European Union

CE IVDR

Valid until

5 Feb 2030

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697404287222K3 Basic UDI-DI 06974042872243UDI-DIDate14 Jul 2026RegisteredStatusActive EUDAMED: not on the EU market

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IVDR 790654 Active

    Technical documentation EU IVDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    6 Feb 2025
    Expires
    5 Feb 2030

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
hCG Pregnancy Rapid Test Kit (Urine) One Step hCG Rapid Test Pen
Model / Reference
CH190GH090GA5T
Primary DI / UDI-DI
06974042872243
Basic UDI-DI
697404287222K3
EMDN Code
W0102050205 Total human chorionic gonadotropin
Device Class
Class B

Manufacturer details

EUDAMED SRN
CN-MF-000008729
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

From the manufacturer

Manufacturer's product page: Drug of Abuse (DOA) Rapid Urine Test

Properties

  • Reagent
  • Self Testing
  • New Device

Other properties (8)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No