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Human Chorionic Gonadotropin Rapid Test Kit (Colloidal Gold)

by Jiangsu Konsung Medical Technology Co., Ltd. 3 variants

Ref FCG-103G-1, FCG-101G-1, FCG-101G-10, FCG-102G-1

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

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/IVDD NumberB-06975132463341 Basic UDI-DI Date7 Jun 2022RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Human Chorionic Gonadotropin Rapid Test Kit (Colloidal Gold)
Model / Reference
FCG-103G-1, FCG-101G-1, FCG-101G-10, FCG-102G-1
Primary DI / UDI-DI
06975132463341, 06975132463310, 06975132463327, 06975132463358
Basic UDI-DI
B-06975132463341, B-06975132463310, B-06975132463327, B-06975132463358
EMDN Code
W0102160302 Hcg - rt & poc
Device Class
Class IVD General
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000004533
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Jiangsu Konsung Medical Technology Co., Ltd.

See all devices from Jiangsu Konsung Medical Technology Co., Ltd. →

Properties

  • Animal Tissues
  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No