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Alanine Aminotransferase Kit( IFCC Method)
EUDAMEDClass IVD General (EU MDR)
Ref 4032Model R1：2x60ml R2:2x15ml
Identity
- Trade Name
- Alanine Aminotransferase Kit( IFCC Method) EUDAMED
- Device Name
- Alanine Aminotransferase Kit( IFCC Method) EUDAMED
- Model / Reference
- R1：2x60ml R2:2x15ml EUDAMED4032 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977565584037 EUDAMED
- Basic UDI-DI
- B-06977565584037 EUDAMED
- EMDN Code
- W01010103 ALANINE AMINO-TRANSFERASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Category: Alanine aminotransferase (ALT) IVD, reagent
Alanine Aminotransferase Kit( IFCC Method) by Coei Biotech Co.Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Alanine aminotransferase (ALT) IVD, reagent.
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- Alinity — Abbott · Class I
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06977565584037 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Coei Biotech Co.Ltd.
- EUDAMED SRN
- CN-MF-000049509
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 18ab80a5-5ab6-4fa5-8262-e343b83a6af0 61 fields · synced Jun 20, 2026