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Bnibt

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

Ref RI003C

EMDN W0105099004

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-06975456580311 Basic UDI-DIDate3 Nov 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Influenza type A and B (Flu A/B)Ag Rapid Test
Model / Reference
RI003C
Primary DI / UDI-DI
06975456580311
Basic UDI-DI
B-06975456580311
EMDN Code
W0105099004 Influenza a and /or b - rt & poc
Device Class
Class IVD General
Market of Registration
Netherlands

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 e33e8e80-53f4-4aad-93cd-f702d6362bfd 61 fields · synced 22 Oct 2026