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Total Iron Binding Capacity Kit (Ferrozine Method)
EUDAMEDClass IVD General (EU MDR)
Ref MJ465YModel 108mL（R1:1×40mL+R2:1×20mL+R3:1×40mL+R4:1×8mL）;Fe Calibrator and UIBC Calibrator:1×1mL
Identity
- Trade Name
- Total Iron Binding Capacity Kit (Ferrozine Method) EUDAMED
- Device Name
- Total Iron Binding Capacity Kit (Ferrozine Method) EUDAMED
- Model / Reference
- 108mL（R1:1×40mL+R2:1×20mL+R3:1×40mL+R4:1×8mL）;Fe Calibrator and UIBC Calibrator:1×1mL EUDAMEDMJ465Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936595750874 EUDAMED
- Basic UDI-DI
- B-06936595750874 EUDAMED
- EMDN Code
- W0102070107 IRON BINDING CAPACITY - TOTAL (IC) 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 Iron Binding Capacity Kit (Ferrozine 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-06936595750874 | 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 401c2ee8-4792-4e0e-8a19-616b1df9b1e2 61 fields · synced Jul 13, 2026