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CorDx Respiratory Antigen Combo Rapid Test (Flu A/B/COVID + PIV/HMPV)

by CorDx, Inc.

Ref ACT21065CCO-1Model Cassette

Active European Union

CE IVDR

Valid until

8 Sep 2031

CE IVDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier Kiwa Sertio Oy

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberEU-TDA-FI-31294-800155-2026 Date14 Oct 2026IssuedStatusActive expires 8 Sep 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • EU-TDA-FI-31294-800155-2026 Active

    Technical documentation EU IVDR

    Certifier
    Kiwa Sertio Oy 3018
    Issued
    14 Oct 2026
    Expires
    8 Sep 2031

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Specification

EUDAMED

Device Name
Respiratory Antigen Combo Rapid Test
Model / Reference
Cassette, ACT21065CCO-1
Primary DI / UDI-DI
00810230661151
Basic UDI-DI
085006791221065CC87
EMDN Code
W0105090699 Other multiple pathogens - rt & poc
Device Class
Class C
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000029255
Authorised representative
Medunion S.L. ES-AR-000019366

Other devices from CorDx, Inc.

See all devices from CorDx, Inc. →

Properties

  • Reagent
  • Self Testing
  • Near-Patient Testing
  • Professional Testing

Other properties (7)

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