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Low Density Lipoprotein Cholesterol Kit(Direct Method)
EUDAMEDClass IVD General (EU MDR)
Ref 5432Model "R1：1x60ml R2:2x10ml "
Identity
- Trade Name
- Low Density Lipoprotein Cholesterol Kit(Direct Method) EUDAMED
- Device Name
- Low Density Lipoprotein Cholesterol Kit(Direct Method) EUDAMED
- Model / Reference
- "R1：1x60ml R2:2x10ml " EUDAMED5432 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06977565585430 EUDAMED
- Basic UDI-DI
- B-06977565585430 EUDAMED
- EMDN Code
- W01010221 LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
Low Density Lipoprotein Cholesterol Kit(Direct Method) by Coei Biotech 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-06977565585430 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Coei Biotech Co.Ltd.
- EUDAMED SRN
- CN-MF-000049509
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (1)
- EUDAMED c2809425-a4bc-418c-b9ca-e66a4d67e117 61 fields · synced Jun 19, 2026