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Homocysteine Kit (Enzyme Cycling Method)
EUDAMEDClass IVD General (EU MDR)
Ref MJ422YModel 45mL（R1:1×35mL+R2:1×10mL）;Calibrator:6×0.3mL
Identity
- Trade Name
- Homocysteine Kit (Enzyme Cycling Method) EUDAMED
- Device Name
- Homocysteine Kit (Enzyme Cycling Method) EUDAMED
- Model / Reference
- 45mL（R1:1×35mL+R2:1×10mL）;Calibrator:6×0.3mL EUDAMEDMJ422Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936595750409 EUDAMED
- Basic UDI-DI
- B-06936595750409 EUDAMED
- EMDN Code
- W01021307 HOMOCYSTEINE 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
Homocysteine Kit (Enzyme Cycling 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-06936595750409 | 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 77c58d09-5a08-4467-bac6-d39bc7a9a4b8 61 fields · synced Jul 12, 2026