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Vitassay qPCR Cryptosporidium+Entamoeba histolytica+Giardia

by Vitassay Healthcare S.L.U 2 variants

Ref 7041012Model Vitassay qPCR Cryptosporidium+Entamoeba histolytica+Giardia , low 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, self-declared

Class I: no certifier involved

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08436592682096 Basic UDI-DI 08436592682096UDI-DIDate5 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Active

Specification

EUDAMED

Device Name
Vitassay qPCR Cryptosporidium+Entamoeba histolytica+Giardia
Model / Reference
Vitassay qPCR Cryptosporidium+Entamoeba histolytica+Giardia, low profile, 4x8-well strips, 7041012
Primary DI / UDI-DI
08436592682096
Basic UDI-DI
B-08436592682096
EMDN Code
W01050704 Multiple parasites panels
Device Class
Class IVD General
EU market of registration
Austria

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