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Bnibt

by Beijing North Institute of Biotechnology Co., Ltd. China EUDAMED

Ref RICOV6-25

EMDN W0105040619

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975456580274 Basic UDI-DIDate2 Nov 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
COVID-19 Neutralizing Antibody Rapid Test
Model / Reference
RICOV6-25
Primary DI / UDI-DI
06975456580274
Basic UDI-DI
B-06975456580274
EMDN Code
W0105040619
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000008259
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Beijing North Institute of Biotechnology Co., Ltd.

See all devices from Beijing North Institute of Biotechnology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 8289705a-8e26-4c71-9815-88a08d0475e9 61 fields · synced 24 Oct 2026