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Hyrespira 5-in-1 Rapid Test

by Heyer Medical AG Germany EUDAMED

Ref 140004Model Multiple Models EMDN W0105099099

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number4251743800016UW Basic UDI-DIDate29 Jul 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • EU-QMS-FI-88700-800168-2026 Issued

    Quality management system EU IVDR

    Notified body
    Notified body 3018
    Issued
    14 Jul 2026
    Expires
    14 Jul 2031
  • EU-TDA-FI-92091-800168-2026 Issued

    Technical documentation EU IVDR

    Notified body
    Notified body 3018
    Issued
    14 Jul 2026
    Expires
    14 Jul 2031

Specification

EUDAMED · synced 24 Oct 2026

Device Name
SARS-CoV-2/FluA/FluB+ADV/RSV Antigen Combo Rapid Test Kit (LFIA)
Model / Reference
Multiple Models, 140004
Primary DI / UDI-DI
04251743800556
Basic UDI-DI
4251743800016UW
EMDN Code
W0105099099 Virology - rt & poc - other
Device Class
Class C
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000014330

Other devices from Heyer Medical AG

See all devices from Heyer Medical AG →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent
  • Self Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Near-Patient Testing: No
  • Professional Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 04251743800556|4251743800016UW 61 fields · synced 24 Oct 2026