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Renin Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref IM4403456, IM4403456Model IM4402456 IM4403456 IM4406456 IM4407456

EMDN W0102060206

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-IM4403456JL Basic UDI-DIDate22 May 2022RegisteredStatusActive
European UnionCE/IVDD NumberB-IM4403456JL 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 23 Oct 2026

Device Name
Renin Chemiluminescent Immunoassay Kit
Model / Reference
IM4403456, IM4402456 IM4403456 IM4406456 IM4407456
Primary DI / UDI-DI
D-IM4403456JL, 06950617401919
Basic UDI-DI
B-IM4403456JL, 69506174IM440456E3
Direct Marketing DI
06950617401919
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

Other devices from Maccura Biotechnology Co., Ltd.

See all devices from Maccura Biotechnology Co., Ltd. →

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 80d6756c-cd40-489b-89ed-e104953f366e 61 fields · synced 23 Oct 2026
  • EUDAMED 06950617401919|69506174IM440456E3 61 fields · synced 11 Jun 2026