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Vitassay qPCR Carbapenemase-generating Enterobacteriaceae

by Vitassay Healthcare S.L.U EUDAMED

Active European Union

Ref 7041057

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-ESMF0000309597041057HG Basic UDI-DIDate7 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Certificates

0 certificates · EUDAMED

No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.

Specification

EUDAMED

Device Name
Vitassay qPCR Carbapenemase-generating Enterobacteriaceae
Model / Reference
7041057
Primary DI / UDI-DI
D-ESMF0000309597041057HG
Basic UDI-DI
B-ESMF0000309597041057HG
EMDN Code
W0105011699 Bacteriology - na reagents - other
Device Class
Class IVD General
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
ES-MF-000030959

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See all devices from Vitassay Healthcare S.L.U →

Properties

  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (7)

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