Identity
- Trade Name
- CHOLESTEROL HDL 2G EUDAMED
- Device Name
- CHOLESTEROL HDL 2G EUDAMED
- Model / Reference
- HDLL-0380 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701700821519 EUDAMED
- Basic UDI-DI
- B-03701700821519 EUDAMED
- EMDN Code
- W01010215 HIGH DENSITY LIPOPROTEIN CHOLESTEROL EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
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
Cholesterol Hdl 2g by Vitalscientific — 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-03701700821519 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (1)
- EUDAMED 42015800-e396-45ce-8153-c7184e4c0c10 61 fields · synced May 23, 2026