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COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold)

by JOYSBIO(Tianjin) Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref joysbio 05

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-697419997G031MN Basic UDI-DIDate7 Feb 2023RegisteredStatusActive

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  • Withdrawn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

Device Name
COVID-19 IgG/IgM Rapid Test Kit (Colloidal Gold)
Model / Reference
joysbio 05
Primary DI / UDI-DI
D-697419997G031MN
Basic UDI-DI
B-697419997G031MN
EMDN Code
W0105040619
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000003953
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from JOYSBIO(Tianjin) Biotechnology Co., Ltd.

Properties

  • Reagent
  • Near-Patient Testing
  • Professional Testing

Other properties (7)

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