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GGT/ALP/ALT/AST/（ALT/AST）for Liver Function Tests

by Diasia Biomedical Technology Co., Ltd. EUDAMED

Active European Union

Ref R231140, R231141, R231143, R231142Model 10 Tests/kit, 25 Tests/kit, 100 Tests/kit, 50 Tests/kit

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06973316743319 Basic UDI-DIDate17 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/IVDD Expiring

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
GGT/ALP/ALT/AST/（ALT/AST）for Liver Function Tests
Model / Reference
10 Tests/kit, R231140, 25 Tests/kit, R231141, 100 Tests/kit, R231143, 50 Tests/kit, R231142
Primary DI / UDI-DI
06973316743319, 06973316743326, 06973316743340, 06973316743333
Basic UDI-DI
B-06973316743319, B-06973316743326, B-06973316743340, B-06973316743333
EMDN Code
W01010401 Multiple enzymes only - clin. chem lab reagents.
Device Class
Class IVD General
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
CN-MF-000010281
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Diasia Biomedical Technology Co., Ltd.

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Properties

Show properties
  • Reagent
  • Professional Testing
Other properties (8)
  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No