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SARS-CoV-2 Neutralizing Antibody Rapid Test

by Hangzhou Immuno Biotech Co., Ltd China EUDAMED

Ref HCOV018NModel 20T/K, SARS-CoV-2 Neutralizing Antibody Rapid Test EMDN W0105040619

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974238910001 Basic UDI-DIDate23 Aug 2024RegisteredStatusActive

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  • Withdrawn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 22 Oct 2026

Model / Reference
20T/K, HCOV018N, SARS-CoV-2 Neutralizing Antibody Rapid Test
Primary DI / UDI-DI
06974238910001, 06974238910018
Basic UDI-DI
B-06974238910001, B-06974238910018
EMDN Code
W0105040619
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000001118
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Hangzhou Immuno Biotech Co., Ltd

See all devices from Hangzhou Immuno Biotech Co., Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (2)

  • EUDAMED 6ef01d87-dd6d-46e5-bf38-c6504f476108 61 fields · synced 22 Oct 2026
  • EUDAMED 06974238910018|B-06974238910018 61 fields · synced 19 May 2026