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Immunoglobulin G Assay Kit (Immunoturbidimetric Method)

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref CH0803306Model CH0105306 CH0101306 CH0801306 CH0800306 CH0802306 CH0803306 CH0804306

EMDN W0102010105

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69506174CH0803066Y 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
CH0105306 CH0101306 CH0801306 CH0800306 CH0802306 CH0803306 CH0804306, CH0803306
Primary DI / UDI-DI
06950617461777
Basic UDI-DI
69506174CH0803066Y
Direct Marketing DI
06950617461777
EMDN Code
W0102010105 Immunoglobulin g
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

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 06950617461777|69506174CH0803066Y 61 fields · synced 24 Oct 2026