Identity
- Trade Name
- AMYLASE SL EUDAMED
- Device Name
- AMYLASE SL EUDAMED
- Model / Reference
- AMSL-0400 EUDAMEDAMSL-5405 EUDAMEDAMSL-0390 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701700815907 EUDAMED03701700815815 EUDAMED03701700815808 EUDAMED
- Basic UDI-DI
- 37017008AMSL008Z EUDAMED
- EMDN Code
- W01010107 AMYLASE - TOTAL EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
Amylase Sl 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 | 37017008AMSL008Z | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (3)
- EUDAMED 6211f2cd-bc44-4f8a-b640-c22007d18066 61 fields · synced Aug 3, 2026
- EUDAMED 01132ed2-6f3a-4935-9a21-014fd1bd6407 61 fields · synced Jul 31, 2026
- EUDAMED 69549b62-4018-4f88-91c7-d411437971ba 61 fields · synced Aug 3, 2026