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Aspartate Aminotransferase Assay Kit (Aspartate Substrate Method)

by Maccura Biotechnology Co., Ltd. EUDAMED

Active European Union

Ref CH0802202Model CH0101202 CH0105202 CH0100202 CH0800202 CH0801202 CH0802202 CH0803202 CH0804202

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69506174CH0802026K Basic UDI-DIDate15 Oct 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Model / Reference
CH0101202 CH0105202 CH0100202 CH0800202 CH0801202 CH0802202 CH0803202 CH0804202, CH0802202
Primary DI / UDI-DI
06950617449171
Basic UDI-DI
69506174CH0802026K
Direct Marketing DI
06950617449171
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

Other devices from Maccura Biotechnology Co., Ltd.

See all devices from Maccura Biotechnology Co., Ltd. →

Properties

Show properties
  • 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