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Aspartate Aminotransferase (AST) Assay Kit (Enzymatic Kinetic Method)
EUDAMEDClass IVD General (EU MDR)
Ref 53H240T
Identity
- Trade Name
- Aspartate Aminotransferase (AST) Assay Kit (Enzymatic Kinetic Method) EUDAMED
- Device Name
- Aspartate Aminotransferase (AST) Assay Kit (Enzymatic Kinetic Method) EUDAMED
- Model / Reference
- 53H240T EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-53H240T8Q EUDAMED
- Basic UDI-DI
- B-53H240T8Q EUDAMED
- EMDN Code
- W01010110 ASPARTATE AMINO-TRANSFERASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Aspartate Aminotransferase (AST) Assay Kit (Enzymatic Kinetic Method) by Yhlo Biotech (nanjing) Co., Ltd. — Class IVD General — CE/MDR — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | B-53H240T8Q | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Yhlo Biotech (nanjing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000050474
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED 3a36943e-9c52-459c-adb4-bb7a9d817ef8 61 fields · synced Oct 7, 2026