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Immunoglobulin M Assay Kit (Immunoturbidimetric Method)

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref CH0800308Model CH0105308      CH0101308    CH0801308   CH0800308    CH0802308    CH0803308       CH0804308

EMDN W0102010107

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69506174CH08030874 Basic UDI-DIDate15 Oct 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

Model / Reference
CH0105308      CH0101308    CH0801308   CH0800308    CH0802308    CH0803308       CH0804308, CH0800308
Primary DI / UDI-DI
06950617463504
Basic UDI-DI
69506174CH08030874
Direct Marketing DI
06950617463504
EMDN Code
W0102010107 Immunoglobulin m
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
  • Animal Tissues
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06950617463504|69506174CH08030874 61 fields · synced 24 Oct 2026