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Apolipoprotein C2 Kit (Immunoturbidimetric Method)
EUDAMEDClass IVD General (EU MDR)
Ref MJ488YModel 240mL R1: 4 × 45 mL+ R2: 4 × 15 mL
Identity
- Trade Name
- Apolipoprotein C2 Kit (Immunoturbidimetric Method) EUDAMED
- Device Name
- Apolipoprotein C2 Kit (Immunoturbidimetric Method) EUDAMED
- Model / Reference
- 240mL R1: 4 × 45 mL+ R2: 4 × 15 mL EUDAMEDMJ488Y EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06936595752144 EUDAMED
- Basic UDI-DI
- B-06936595752144 EUDAMED
- EMDN Code
- W0102010402 APOLIPOPROTEIN A II 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
Apolipoprotein C2 Kit (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-06936595752144 | 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 e06d9f21-04fe-4a75-870c-4b6195b30a3a 61 fields · synced Jul 23, 2026