Skip to content

SARS-CoV-2 Neutralizing antibody Rapid Test Kit

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

Ref C011914Model 25 tests/ kit EMDN W0105099099

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06950917930201 Basic UDI-DIDate21 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  • Withdrawn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 · synced 22 Oct 2026

Device Name
SARS-CoV-2 Neutralizing antibody Rapid Test Kit
Model / Reference
25 tests/ kit, C011914
Primary DI / UDI-DI
06950917930201
Basic UDI-DI
B-06950917930201
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.

See all devices from Triplex International Biosciences (China) Co., LTD. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED a8ffc9ec-9f90-4b31-b89f-931ec343986f 61 fields · synced 22 Oct 2026