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RF-IgM Chemiluminescent Immunoassay Kit

by Maccura Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref IM4406270Model IM4402270 IM4403270 IM4406270 IM4407270 IM4410270 IM4411270 IM4414270 IM4415270

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69506174IM440270DK Basic UDI-DIDate29 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

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.

Specification

EUDAMED

Device Name
RF-IgM Chemiluminescent Immunoassay Kit
Model / Reference
IM4402270 IM4403270 IM4406270 IM4407270 IM4410270 IM4411270 IM4414270 IM4415270, IM4406270
Primary DI / UDI-DI
06950617433712
Basic UDI-DI
69506174IM440270DK
Direct Marketing DI
06950617433712
EMDN Code
W01021199 Rheumatoid / inflammatory disease markers - 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

  • 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