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SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)

by Shenzhen Microprofit Biotech Co., Ltd EUDAMED

Active European Union

Ref MF-71-5, MF-71-1, ISIR-9334, CG127001

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06971348761325 Basic UDI-DIDate13 Jul 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

No EU certificate is linked to this device in EUDAMED.

Specification

EUDAMED

Trade Name
SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)
SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit
SARS-CoV-2 & Influenza A/B & RSV Antigen Kit (Colloidal Gold)
Model / Reference
MF-71-5, MF-71-1, ISIR-9334, CG127001
Primary DI / UDI-DI
06971348761325, 06971348761301, 06939663978415, 06971225938406
Basic UDI-DI
B-06971348761325, B-06971348761301, B-06939663978415, B-06971225938406
EMDN Code
W0105070399, W0105099099, W0105070304
Device Class
Class IVD devices for self-testing
Class IVD General
Market of Registration
Italy
Greece

Manufacturer details

EUDAMED SRN
CN-MF-000019518
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

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Properties

  • Animal Tissues YesEUDAMEDNoEUDAMED
  • Reagent YesEUDAMEDNoEUDAMED
  • Self Testing YesEUDAMEDNoEUDAMED
  • Near-Patient Testing NoEUDAMEDYesEUDAMED
  • Professional Testing NoEUDAMEDYesEUDAMED

Other properties (5)

  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Companion Diagnostics: No
  • Surgical Instrument: No