← Back to catalogue
Alanine Aminotransferase (ALT) Assay Kit (Enzymatic Kinetic Method)
EUDAMEDClass IVD General (EU MDR)
Ref 52H50TSCRef 52H50T
Identity
- Trade Name
- Alanine Aminotransferase (ALT) Assay Kit (Enzymatic Kinetic Method) EUDAMED
- Device Name
- Alanine Aminotransferase (ALT) Assay Kit (Enzymatic Kinetic Method) EUDAMED
- Model / Reference
- 52H50TSC EUDAMED52H50T EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-52H50TSCSA EUDAMEDD-52H50TVE EUDAMED
- Basic UDI-DI
- B-52H50TSCSA EUDAMEDB-52H50TVE EUDAMED
- EMDN Code
- W01010103 ALANINE 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
Alanine Aminotransferase (ALT) Assay Kit (Enzymatic Kinetic Method) by Yhlo Biotech (nanjing) Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
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-52H50TSCSA | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Yhlo Biotech (nanjing) Co., Ltd.
- EUDAMED SRN
- CN-MF-000050474
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED 2c9a68e4-712c-4ced-a0cb-c8a6388d2f7f 61 fields · synced Oct 6, 2026
- EUDAMED 3091594d-ed34-4d83-8f2f-e192673d6c2b 61 fields · synced May 18, 2026