Identity
- Trade Name
- CHOLESTEROL LDL 2G EUDAMEDCHOLESTEROL LDL SL 2G FDA UDI
- Generic Name
- Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry FDA UDI
- Device Name
- CHOLESTEROL LDL 2G EUDAMED
- Model / Reference
- LDLL-0230 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701700824602 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03701700824602 EUDAMED
- EMDN Code
- W01010221 LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL EUDAMED
- GMDN Term
- Low density lipoprotein (LDL) cholesterol IVD, kit, spectrophotometry FDA UDI
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Cholesterol Ldl 2g by Vitalscientific — Class IVD General — IVDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-03701700824602 | Class IVD General | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IVD General | Pending data |
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Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (2)
- EUDAMED a7fe2b02-3d0c-46ba-9f04-d38509d94200 61 fields · synced Aug 1, 2026
- FDA UDI 1117ac7c-79fb-489c-9ea2-5776bb60cf2b 32 fields · synced May 30, 2026