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Aspartate Aminotransferase Assay Kit (Aspartate Substrate Method)

by Maccura Biotechnology Co., Ltd. China EUDAMED

Ref CH0800202Model CH0101202 CH0105202 CH0100202 CH0800202 CH0801202 CH0802202 CH0803202 CH0804202

EMDN W01010110

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69506174CH0802026K 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
CH0101202 CH0105202 CH0100202 CH0800202 CH0801202 CH0802202 CH0803202 CH0804202, CH0800202
Primary DI / UDI-DI
06950617449157
Basic UDI-DI
69506174CH0802026K
Direct Marketing DI
06950617449157
EMDN Code
W01010110 Aspartate amino-transferase
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
  • 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 06950617449157|69506174CH0802026K 61 fields · synced 24 Oct 2026