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LyoSens Cryptosporidium, Giardia & E. Histolytica Detection qPCR Kit

by Vitrosens Biotechnology Inc.

Ref LYO32

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-08683548258861 Basic UDI-DI 08683548258861UDI-DIDate8 May 2024RegisteredStatusActive

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  • Withdrawn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
Cryptosporidium, Giardia & E. Histolytica Detection qPCR Kit
Model / Reference
LYO32
Primary DI / UDI-DI
08683548258861
Basic UDI-DI
B-08683548258861
EMDN Code
W0105050201, W0105050207, W0105050208
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
TR-MF-000026452

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Properties

  • Reagent
  • Near-Patient Testing
  • Professional Testing
  • Companion Diagnostics
  • Surgical Instrument

Other properties (5)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No