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Cholesterol Ldl 2g Calibrator
EUDAMEDFDA UDIClass IVD General (EU MDR)
Ref LDLL-0011Ref LDLL-0041
Identity
- Trade Name
- CHOLESTEROL LDL 2G CALIBRATOR EUDAMEDFDA UDI
- Generic Name
- Low density lipoprotein (LDL) cholesterol IVD, calibrator FDA UDI
- Device Name
- CHOLESTEROL LDL 2G CALIBRATOR EUDAMED
- Model / Reference
- LDLL-0011 EUDAMEDLDLL-0041 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 03701700824510 EUDAMED03701700824503 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03701700824510 EUDAMEDB-03701700824503 EUDAMED
- EMDN Code
- W0101050302 CALIBRATORS SINGLE COMPONENT (CC) EUDAMED
- GMDN Term
- Low density lipoprotein (LDL) cholesterol IVD, calibrator 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
Yes
EUDAMED
Animal Tissues
No
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
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 Calibrator 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-03701700824510 | 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 (3)
- EUDAMED f8fc65f9-c57a-4883-baed-ad2d250dd732 61 fields · synced Jul 20, 2026
- EUDAMED 259bf238-1f38-4421-903e-fc907eb25185 61 fields · synced May 17, 2026
- FDA UDI 53c15b67-f66e-4b88-b5a3-3d863907e737 32 fields · synced May 29, 2026