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Vitassay qPCR Primary Atypical Pneumonia

by Vitassay Healthcare S.L.U 5 variants

Ref 7042049Model Vitassay qPCR Primary Atypical Pneumonia, high profile, 4x8-well strips

Active European Union

CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08436592683338 Basic UDI-DI 08436592683338UDI-DIDate5 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Vitassay qPCR Primary Atypical Pneumonia
Model / Reference
Vitassay qPCR Primary Atypical Pneumonia, high profile, 4x8-well strips, 7042049
Primary DI / UDI-DI
08436592683338
Basic UDI-DI
B-08436592683338
EMDN Code
W0105070503 Respiratory tract infections - multiplex na reagents
Device Class
Class IVD Annex II List B
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
ES-MF-000030959

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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