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Anti-SLA/LP Antibody Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref IM4411458Model IM4410458 IM4411458 IM4414458 IM4415458

EMDN W0102100799

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69506174IM441458EE Basic UDI-DIDate28 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Anti-SLA/LP Antibody Chemiluminescent Immunoassay Kit
Model / Reference
IM4410458 IM4411458 IM4414458 IM4415458, IM4411458
Primary DI / UDI-DI
06950617403692, D-IM4411458JM
Basic UDI-DI
69506174IM441458EE, B-IM4411458JM
Direct Marketing DI
06950617403692
EMDN Code
W0102100799, W0102109099
Device Class
Class B
Class IVD General
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
CN-MF-000014618
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Properties & raw data

Show properties, registry sources and raw records
  • Animal Tissues
  • Microbial Substances NoEUDAMEDYesEUDAMED
  • 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 d4a2c345-82cb-46f8-add0-9123fc5fa7a8 61 fields · synced 22 Oct 2026
  • EUDAMED D-IM4411458JM|B-IM4411458JM 61 fields · synced 19 May 2026