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C-Reactive Protein Kit (Latex-Enhanced Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref MJ408YModel 150mL（R1:2×60mL+R2:2×15mL）Ref MJ021YModel 100mL（R1:2×40mL+R2:2×10mL）
Identity
- Trade Name
- C-Reactive Protein Kit (Latex-Enhanced Immunoturbidimetric Method) EUDAMEDHigh Sensitivity C-Reactive Protein Kit (Latex-Enhanced Immunoturbidimetric Method) EUDAMED
- Device Name
- C-Reactive Protein Kit (Latex-Enhanced Immunoturbidimetric Method) EUDAMEDHigh Sensitivity C-Reactive Protein Kit (Latex-Enhanced Immunoturbidimetric Method) EUDAMED
- Model / Reference
- 150mL（R1:2×60mL+R2:2×15mL） EUDAMEDMJ408Y EUDAMED100mL（R1:2×40mL+R2:2×10mL） EUDAMEDMJ021Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936595750263 EUDAMED06936595751901 EUDAMED
- Basic UDI-DI
- B-06936595750263 EUDAMEDB-06936595751901 EUDAMED
- EMDN Code
- W01021109 C-REACTIVE PROTEIN EUDAMEDW01021308 HIGH-SENSITIVITY C-.REACTIVE PROTEIN 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
C-Reactive Protein Kit (Latex-Enhanced Immunoturbidimetric 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-06936595750263 | 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 (2)
- EUDAMED 9c719e0b-8150-41e5-bb08-0cc26a565228 61 fields · synced Jul 10, 2026
- EUDAMED bf67f9d5-20fd-4d55-9b0f-91082275d535 61 fields · synced May 18, 2026