Skip to content

Leishmania Real Time PCR Kit

by Jiangsu Bioperfectus Technologies Co., Ltd. United States EUDAMED

Ref YJB30123NW-25T

EMDN W0105050205

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-YJB30123NW-25TXU Basic UDI-DIDate8 Aug 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Model / Reference
YJB30123NW-25T
Primary DI / UDI-DI
D-YJB30123NW-25TXU
Basic UDI-DI
B-YJB30123NW-25TXU
EMDN Code
W0105050205 Leishmania
Device Class
Class IVD General
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000014691
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (6)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No

Sources (1)

  • EUDAMED e2ccbeaa-d8f0-4cfe-a4a8-33b2ea1eec20 61 fields · synced 22 Oct 2026