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AMA-M2 Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref IM4414267Model IM4410267 IM4411267 IM4414267 IM4415267

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number69506174IM441267E5 Basic UDI-DIDate29 Apr 2026RegisteredStatusActive
European UnionCE/IVDR Number69506174IM441267E5 Basic UDI-DIDate29 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
AMA-M2 Chemiluminescent Immunoassay Kit
Model / Reference
IM4410267 IM4411267 IM4414267 IM4415267, IM4414267
Primary DI / UDI-DI
06950617402800, D-IM4414267JZ
Basic UDI-DI
69506174IM441267E5, B-IM4414267JZ
Direct Marketing DI
06950617402800
EMDN Code
W0102120199, 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

Other devices from Maccura Biotechnology Co., Ltd.

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

Properties

Show properties
  • Animal Tissues
  • Microbial Substances
  • 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