Identity
- Trade Name
- ELITROL II EUDAMED
- Device Name
- ELITROL EUDAMED
- Model / Reference
- ELITROL I EUDAMEDCONT-1160 EUDAMEDCONT-0160 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701700819516 EUDAMED03701700819509 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 Ii 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 |
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Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (2)
- EUDAMED ec6d1976-99b0-4d2e-8b3c-05b364a0b7fb 61 fields · synced Jul 18, 2026
- EUDAMED 2468f38e-1e31-459b-bc1f-6697813540de 61 fields · synced May 17, 2026