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Leishmania IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

by Healgen Scientific Limited Liability Company United States EUDAMED

Ref GCKal-T402a

EMDN W0105050205

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-GCKal-T402aHGQK Basic UDI-DIDate31 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Expiring (legacy directive)
  • Not covered

European Union — CE/IVDD Expiring (legacy directive)

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
GCKal-T402a
Primary DI / UDI-DI
D-GCKal-T402aHGQK, D-GCKal-T402aYL
Basic UDI-DI
B-GCKal-T402aHGQK, B-GCKal-T402aYL
EMDN Code
W0105050205 Leishmania
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
US-MF-000018839
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Healgen Scientific Limited Liability Company

See all devices from Healgen Scientific Limited Liability Company →

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Reagent NoEUDAMEDYesEUDAMED
  • 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

Sources (2)

  • EUDAMED 48c835bf-04cf-4ae5-8ca8-852116eb2f6c 61 fields · synced 22 Oct 2026
  • EUDAMED D-GCKAL-T402AYL|B-GCKAL-T402AYL 61 fields · synced 5 Oct 2026