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ELISA-VIDITEST anti-Borelia recombinant IgM (CSF)

by VIDIA spol. s r.o. 4 variants

Ref OD-399/5STModel ELISA-VIDITEST anti-Borelia recombinant IgM (CSF)

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-48594036043990 Basic UDI-DI 48594036043990UDI-DIDate29 May 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  • Withdrawn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

Model / Reference
ELISA-VIDITEST anti-Borelia recombinant IgM (CSF), OD-399/5ST
Primary DI / UDI-DI
48594036043990
Basic UDI-DI
B-48594036043990
EMDN Code
W0105010604 Lyme antibody igm
Device Class
Class IVD General
EU market of registration
Czechia

Manufacturer details

EUDAMED SRN
CZ-MF-000036964

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Properties

  • Human Tissues
  • Microbial Substances
  • Professional Testing

Other properties (7)

  • Sterile: No
  • Animal Tissues: No
  • Reagent: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No