Skip to content

Leptospira IgG/IgM Test Device-Fingerstick WB, WB/S/P

by Rapid Labs Ltd 2 variants

Ref D-FILEPGMD10

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-D-FILEPGMD10ZV Basic UDI-DI D-D-FILEPGMD10ZVUDI-DIDate28 Sep 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  • Withdrawn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
D-FILEPGMD10
Primary DI / UDI-DI
D-D-FILEPGMD10ZV
Basic UDI-DI
B-D-FILEPGMD10ZV
EMDN Code
W0105090199 Bacteriology - rt & poc - other
Device Class
Class IVD General
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
GB-MF-000026335
Authorised representative
VidaQuick Biotech S.L. ES-AR-000048138

Other devices from Rapid Labs Ltd

See all devices from Rapid Labs Ltd →

Properties

  • Professional Testing

Other properties (10)

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