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Kalazar Detect™ Rapid Test

by InBios International, Inc. EUDAMED

Active European Union

Ref INS020

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-++B379INS0201E Basic UDI-DIDate8 Jan 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  • Withdrawn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

Device Name
Kalazar Detect™ Rapid Test
Model / Reference
INS020
Primary DI / UDI-DI
++B379INS0201E
Basic UDI-DI
B-++B379INS0201E
EMDN Code
W0105090499 Parasites - rt & poc - other
Device Class
Class IVD General
Market of Registration
Ireland

Manufacturer details

EUDAMED SRN
US-MF-000020625
Authorised representative
AR Experts B.V. NL-AR-000023989

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Properties

  • Reagent
  • Professional Testing

Other properties (8)

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