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SARS-CoV-2 Neutralizing antibody Rapid Test Kit (TRFIA)

by Triplex International Biosciences (China) Co., LTD. EUDAMED

Active European Union

Ref C011918Model 25 tests/ kit

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06950917930164 Basic UDI-DIDate20 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  • Withdrawn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 Neutralizing antibody Rapid Test Kit (TRFIA)
Model / Reference
25 tests/ kit, C011918
Primary DI / UDI-DI
06950917930164
Basic UDI-DI
B-06950917930164
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class IVD General
Market of Registration
France

Manufacturer details

EUDAMED SRN
CN-MF-000001097
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Triplex International Biosciences (China) Co., LTD.

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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