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HVRe Influenza/RSV/SARS-CoV-2

by Fluxergy Inc. EUDAMED

Withdrawn No longer placed on the EU market

Ref 8032

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-00850027856612 Basic UDI-DIDate4 Mar 2024RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Fluxergy HVRe Influenza/RSV/ SARS-CoV-2
Model / Reference
8032
Primary DI / UDI-DI
00850027856612
Basic UDI-DI
B-00850027856612
EMDN Code
W0105070399 Multiple viruses - multiplex assays - other
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000010833
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Fluxergy Inc.

Properties

  • 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