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Leishmania IgG/IgM Rapid Test Device

by Rapid Labs Ltd EUDAMED

Active European Union

Ref D-LEIGMD20

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-D-LEIGMD20T2 Basic UDI-DIDate31 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
D-LEIGMD20
Primary DI / UDI-DI
D-D-LEIGMD20T2
Basic UDI-DI
B-D-LEIGMD20T2
EMDN Code
W0105050205 Leishmania
Device Class
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
GB-MF-000026335
Authorised representative
Advena Limited MT-AR-000000234

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See all devices from Rapid Labs Ltd →

Properties

Show 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