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AMA-M2 Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd. 3 variants

Ref IM4415267Model IM4410267 IM4411267 IM4414267 IM4415267

Active European Union

CE IVDR CE IVDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD Number69506174IM441267E5 Basic UDI-DI Date29 Apr 2026RegisteredStatusActive
European UnionCE/IVDR Number69506174IM441267E5 Basic UDI-DI Date29 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDD, CE/IVDR Active

Specification

EUDAMED

Device Name
AMA-M2 Chemiluminescent Immunoassay Kit
Model / Reference
IM4410267 IM4411267 IM4414267 IM4415267, IM4415267
Primary DI / UDI-DI
06950617402817, D-IM4415267K8
Basic UDI-DI
69506174IM441267E5, B-IM4415267K8
Direct Marketing DI
06950617402817
EMDN Code
W0102120199, W0102109099
Device Class
Class B
Class IVD General
EU 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

  • 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