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cobas lumira SARS-CoV-2 Ag Ultra QC

by Roche Diagnostics GmbH 2 variants

Ref 10549602001

Active European Union

CE IVDR

Valid until

13 Aug 2031

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 Number761333603257AZ Basic UDI-DI 07613336238097UDI-DIDate28 Sep 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  • Withdrawn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

Model / Reference
10549602001
Primary DI / UDI-DI
07613336238097
Basic UDI-DI
761333603257AZ
Unit of Use DI
07613336249635
EMDN Code
W0105094001 Controls infectious immunology - rt & poc
Device Class
Class B
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
DE-MF-000006260

Other devices from Roche Diagnostics GmbH

See all devices from Roche Diagnostics GmbH →

Properties

  • Human Tissues
  • Microbial Substances
  • Near-Patient Testing
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Animal Tissues: No
  • Reagent: No
  • Self Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No