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COVID-19 Antigen Rapid Testing Kit (Colloidal Gold)

by Zhongshan Bio-Tech Co., Ltd. EUDAMED

Active European Union

Ref XG0310-10Model 10 Tests/Kit

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06936791020047 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  • Withdrawn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
COVID-19 Antigen Rapid Testing Kit (Colloidal Gold)
Model / Reference
10 Tests/Kit, XG0310-10
Primary DI / UDI-DI
06936791020047
Basic UDI-DI
B-06936791020047
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class IVD devices for self-testing
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000028828
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Zhongshan Bio-Tech Co., Ltd.

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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