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SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)

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

Active European Union

Ref joysbio 01

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-697419997WR Basic UDI-DIDate14 Oct 2022RegisteredStatusActive

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  • Withdrawn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
SARS-CoV-2 Antigen Rapid Test Kit (Colloidal Gold)
Model / Reference
joysbio 01
Primary DI / UDI-DI
D-697419997WR
Basic UDI-DI
B-697419997WR
EMDN Code
W0105900299 Infectious immunology - other
Device Class
Class IVD devices for self-testing
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

Show properties
  • Animal Tissues
  • Reagent
  • Self Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No