Skip to content

Anti-histone Antibody Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref IM4410264, IM4414264, IM4415264Model IM4410264 IM4411264 IM4414264 IM4415264

EMDN W0102100107

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR NumberB-IM4410264HX Basic UDI-DIDate22 May 2022RegisteredStatusActive
European UnionCE/IVDD NumberB-IM4410264HX 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
Anti-histone Antibody Chemiluminescent Immunoassay Kit
Model / Reference
IM4410264, IM4414264, IM4410264 IM4411264 IM4414264 IM4415264, IM4415264
Primary DI / UDI-DI
D-IM4410264HX, D-IM4414264JT, 06950617403081, 06950617403067, 06950617403098, D-IM4415264K2
Basic UDI-DI
B-IM4410264HX, B-IM4414264JT, 69506174IM441264DX, B-IM4415264K2
Direct Marketing DI
06950617403081
06950617403067
06950617403098
EMDN Code
W0102100107 Histones (h1, h2a, h3, h4,…hn)
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
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (6)

  • EUDAMED bedae6a5-cdd3-42df-a22f-ac7f9f5d8fe7 61 fields · synced 22 Oct 2026
  • EUDAMED D-IM4414264JT|B-IM4414264JT 61 fields · synced 17 May 2026
  • EUDAMED 06950617403081|69506174IM441264DX 61 fields · synced 17 May 2026
  • EUDAMED 06950617403067|69506174IM441264DX 61 fields · synced 17 May 2026
  • EUDAMED 06950617403098|69506174IM441264DX 61 fields · synced 19 May 2026
  • EUDAMED D-IM4415264K2|B-IM4415264K2 61 fields · synced 19 May 2026