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FLU A+B Antigen combo Rapid Test

by Hangzhou Higene Biotechnology Co., LTD. China EUDAMED

Ref nFLuAG

EMDN W0105099004

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-16974198353013 Basic UDI-DIDate26 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 23 Oct 2026

Device Name
FLU A+B Antigen combo Rapid Test
Model / Reference
nFLuAG
Primary DI / UDI-DI
16974198353013
Basic UDI-DI
B-16974198353013
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-000029811
Authorised representative
Lotus NL B.V. NL-AR-000000121

Other devices from Hangzhou Higene 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 cd41769b-58d9-4dc6-9b53-570a1351e91b 61 fields · synced 23 Oct 2026