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SARS-Cov-2 Antigen Rapid Test

by Hangzhou Higene Biotechnology Co., LTD. China EUDAMED

Ref nCoVAG EMDN W0105040619

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-16974198355017 Basic UDI-DIDate26 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  • Withdrawn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 25 Oct 2026

Device Name
SARS-Cov-2 Antigen Rapid Test
Model / Reference
nCoVAG
Primary DI / UDI-DI
16974198355017
Basic UDI-DI
B-16974198355017
EMDN Code
W0105040619
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 7003ade1-7c2f-447d-8879-4ae1206de8c0 61 fields · synced 25 Oct 2026