Identity
- Trade Name
- ELITROL I EUDAMED
- Device Name
- ELITROL EUDAMED
- Model / Reference
- ELITROL I EUDAMEDCONT-0060 EUDAMEDCONT-1060 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701700819400 EUDAMED03701700819417 EUDAMED
- Basic UDI-DI
- 37017008CONT05AY EUDAMED
- EMDN Code
- W0101050101 ASSAYED MULTICOMPONENT CONTROLS (CC) EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
New Device
No
EUDAMED
Elitrol I by Vitalscientific — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 37017008CONT05AY | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (2)
- EUDAMED 5abd7d08-02ca-4d25-bd60-938519374622 61 fields · synced Jul 22, 2026
- EUDAMED df62604d-9884-483c-9899-6cbef2594ecb 61 fields · synced Jul 22, 2026