Skip to content

Renin Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref IM4402456Model IM4402456 IM4403456 IM4406456 IM4407456

EMDN W0102060206

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-IM4402456JD Basic UDI-DIDate22 May 2022RegisteredStatusActive
European UnionCE/IVDD NumberB-IM4402456JD Basic UDI-DIDate22 May 2022RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR, CE/IVDD Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Renin Chemiluminescent Immunoassay Kit
Model / Reference
IM4402456, IM4402456 IM4403456 IM4406456 IM4407456
Primary DI / UDI-DI
D-IM4402456JD, 06950617401902
Basic UDI-DI
B-IM4402456JD, 69506174IM440456E3
Direct Marketing DI
06950617401902
EMDN Code
W0102060206, W0102060204
Device Class
Class IVD General
Class B
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000014618
Authorised representative
Humiss International B.V. NL-AR-000001490

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances YesEUDAMEDNoEUDAMED
  • Reagent
  • Professional Testing
Other properties (7)
  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (2)

  • EUDAMED cff2b03c-2677-465c-b79f-ec9c9fb81fce 61 fields · synced 22 Oct 2026
  • EUDAMED 01696442-7613-4cd3-92ed-879f3d99544b 61 fields · synced 15 Jul 2026