← Back to catalogue
Alanine Aminotransferase Kit (Kinetic Method)
EUDAMEDClass IVD General (EU MDR)
Ref MJ001YModel 300mL（R1:4×50mL+R2:2×50mL）
Identity
- Trade Name
- Alanine Aminotransferase Kit (Kinetic Method) EUDAMED
- Device Name
- Alanine Aminotransferase Kit (Kinetic Method) EUDAMED
- Model / Reference
- 300mL（R1:4×50mL+R2:2×50mL） EUDAMEDMJ001Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936595747461 EUDAMED
- Basic UDI-DI
- B-06936595747461 EUDAMED
- EMDN Code
- W01010103 ALANINE AMINO-TRANSFERASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Alanine Aminotransferase Kit (Kinetic Method) by Medicalsystem Biotechnology 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-06936595747461 | Class IVD General | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- MedicalSystem Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010246
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 0bf0641f-be48-4a28-ac8a-a4c3396690c2 61 fields · synced Jun 18, 2026