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Immunological Multi-Parameter Control

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref IM4402369Model IM4400369 IM4403369 IM4406369 IM4401369 IM4404369 IM4407369 IM4402369 IM4405369 IM4408369

EMDN W0102152099

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69506174IM440369E7 Basic UDI-DIDate16 Jun 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
Immunological Multi-Parameter Control
Model / Reference
IM4400369 IM4403369 IM4406369 IM4401369 IM4404369 IM4407369 IM4402369 IM4405369 IM4408369, IM4402369
Primary DI / UDI-DI
06950617487913
Basic UDI-DI
69506174IM440369E7
Direct Marketing DI
06950617487913
EMDN Code
W0102152099 Controls- immunochemistry - other
Device Class
Class B
Market of Registration
Spain

Manufacturer details

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

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
  • Microbial Substances
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06950617487913|69506174IM440369E7 61 fields · synced 24 Oct 2026