← Back to catalogue
Sodium Kit (Enzymatic Method)
EUDAMEDClass IVD General (EU MDR)
Ref MJ432YModel 240mL(R1:4×45mL+R2:4×15mL);Calibrator:2×1mL
Identity
- Trade Name
- Sodium Kit (Enzymatic Method) EUDAMED
- Device Name
- Sodium Kit (Enzymatic Method) EUDAMED
- Model / Reference
- 240mL(R1:4×45mL+R2:4×15mL);Calibrator:2×1mL EUDAMEDMJ432Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936595750539 EUDAMED
- Basic UDI-DI
- B-06936595750539 EUDAMED
- EMDN Code
- W01010309 SODIUM 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
Sodium Kit (Enzymatic Method) by Medicalsystem Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-06936595750539 | 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 5a7f67d2-0a27-4a78-aa07-2a372e76afb9 61 fields · synced Jun 18, 2026