Identity
- Trade Name
- CHOLESTEROL EUDAMEDCHOLESTEROL LDL 2G EUDAMED
- Device Name
- CHOLESTEROL EUDAMEDCHOLESTEROL LDL 2G EUDAMED
- Model / Reference
- CHSL-M690 EUDAMEDLDLL-0380 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701700802600 EUDAMED03701700824619 EUDAMED
- Basic UDI-DI
- 37017008CHSL0186 EUDAMEDB-03701700824619 EUDAMED
- EMDN Code
- W01010205 CHOLESTEROL EUDAMEDW01010221 LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL EUDAMED
Classification
- Device Class
- Class B EUDAMEDClass IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMEDEUDAMED
Microbial Substances
Yes
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
New Device
No
EUDAMED
Category: Total cholesterol lipid IVD, reagent
Cholesterol by Vitalscientific — Class B — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | 37017008CHSL0186 | Class B | Active |
| EUDAMED | European Union | CE/IVDR | 37017008CHSL0186 | Class B | Active |
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Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (2)
- EUDAMED 7e27a576-6111-4327-aab9-219646b212ca 61 fields · synced Jul 11, 2026
- EUDAMED aef43645-40f3-4c0d-bdba-af77d759baf8 61 fields · synced May 18, 2026