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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 3 variants

Ref MF-071-2

Active European Union

CE IVDR

Valid until

8 Oct 2030

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697134876071D29643B Basic UDI-DI 06971348763718UDI-DIDate15 Jun 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)
Model / Reference
MF-071-2
Primary DI / UDI-DI
06971348763718
Basic UDI-DI
697134876071D29643B
Direct Marketing DI
06971348763718
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class C
EU market of registration
Spain

Manufacturer details

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

Other devices from Shenzhen Microprofit Biotech Co., Ltd

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Properties

  • Reagent
  • Self Testing
  • New Device

Other properties (8)

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