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Bnibt

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

Ref 10005844Model RICOV4, RICOV4-20

EMDN W0105040619

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06975456580205 Basic UDI-DIDate25 Oct 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 22 Oct 2026

Device Name
COVID-19 Antigen Rapid Test
Model / Reference
RICOV4, 10005844, RICOV4-20
Primary DI / UDI-DI
06975456580205, 06975456580212
Basic UDI-DI
B-06975456580205, B-06975456580212
EMDN Code
W0105040619
Device Class
Class IVD devices for self-testing
Class IVD General
Market of Registration
Poland

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

Sources (2)

  • EUDAMED 4565c5d2-bb66-4896-9ff4-9483bea91451 61 fields · synced 22 Oct 2026
  • EUDAMED 06975456580212|B-06975456580212 61 fields · synced 19 May 2026