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γ-Glutamyltransferase Assay Kit (Glycylglycine Cyanide Anilide Method)

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref CH0803204 Model CH0101204 CH0105204 CH0100204 CH0800204 CH0801204 CH0802204 CH0803204 CH0804204

EMDN W01010116

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69506174CH0802046P Basic UDI-DIDate12 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
CH0101204 CH0105204 CH0100204 CH0800204 CH0801204 CH0802204 CH0803204 CH0804204, CH0803204
Primary DI / UDI-DI
06950617446910
Basic UDI-DI
69506174CH0802046P
Direct Marketing DI
06950617446910
EMDN Code
W01010116 Gamma glutamyltransferase
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
  • Reagent
  • Professional Testing
Other properties (9)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No

Sources (1)

  • EUDAMED 06950617446910|69506174CH0802046P 61 fields · synced 23 Oct 2026