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Respiratory Syncytial Virus Antigen Rapid Test

by Hangzhou Immuno Biotech Co., Ltd EUDAMED

Active European Union

Ref HRSV022GModel Respiratory Syncytial Virus Antigen Rapid Test

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06974238911077 Basic UDI-DIDate13 Mar 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
Respiratory Syncytial Virus Antigen Rapid Test, HRSV022G
Primary DI / UDI-DI
06974238911077
Basic UDI-DI
B-06974238911077
EMDN Code
W0105040605 Respiratory syncytial virus (rsv)
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

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Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No