Identity
- Trade Name
- ALP IFCC EUDAMED
- Device Name
- ALP IFCC EUDAMED
- Model / Reference
- ALPI-5100 EUDAMEDALPI-6050 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701700800613 EUDAMED03701700800620 EUDAMED
- Basic UDI-DI
- 37017008ALPI037Q EUDAMED
- EMDN Code
- W01010105 ALKALINE PHOSPHATASE - 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
Alp Ifcc 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 | 37017008ALPI037Q | Class B | Active |
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Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (2)
- EUDAMED 0788c81c-af28-4621-837e-8a117b3d278b 61 fields · synced Sep 17, 2026
- EUDAMED 394186e4-791c-49e8-a574-6cd489c10ff5 61 fields · synced May 18, 2026