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Total Bilirubin Kit (Nitrite Oxidation Method)
EUDAMEDClass IVD General (EU MDR)
Ref MJ115YModel 250mL（R1:4×50mL+R2:1×50mL）
Identity
- Trade Name
- Total Bilirubin Kit (Nitrite Oxidation Method) EUDAMED
- Device Name
- Total Bilirubin Kit (Nitrite Oxidation Method) EUDAMED
- Model / Reference
- 250mL（R1:4×50mL+R2:1×50mL） EUDAMEDMJ115Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936595747546 EUDAMED
- Basic UDI-DI
- B-06936595747546 EUDAMED
- EMDN Code
- W01010203 BILIRUBIN 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
Total Bilirubin Kit (Nitrite Oxidation 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-06936595747546 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- MedicalSystem Biotechnology Co., Ltd.
- EUDAMED SRN
- CN-MF-000010246
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (1)
- EUDAMED 48e5cd3f-1d26-4080-867b-3919622562cb 61 fields · synced Jul 12, 2026