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GenSure Flu A+B Ag Rapid Test

by GenSure Biotech Inc. EUDAMED

Active European Union

Ref P2018C01

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697683823P201800F4 Basic UDI-DIDate18 Jul 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Specification

EUDAMED

Device Name
Flu A+B Ag Rapid Test
Model / Reference
P2018C01
Primary DI / UDI-DI
16976838230302
Basic UDI-DI
697683823P201800F4
EMDN Code
W0105099004 Influenza a and /or b - rt & poc
Device Class
Class C
Market of Registration
Cyprus

Manufacturer details

EUDAMED SRN
CN-MF-000028354
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

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Properties

  • Animal Tissues
  • Reagent
  • Self Testing
  • Professional Testing
  • New Device

Other properties (6)

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