Identity
- Trade Name
- ALT/GPT 4+1 SL EUDAMED
- Device Name
- ALT/GPT 4+1 SL EUDAMED
- Model / Reference
- ALSL-5415 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701700815419 EUDAMED
- Basic UDI-DI
- 37017008ALSL008N EUDAMED
- EMDN Code
- W01010103 ALANINE AMINO-TRANSFERASE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
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
Category: Alanine aminotransferase (ALT) IVD, reagent
Alt/Gpt 4+1 Sl by Vitalscientific — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Alanine aminotransferase (ALT) IVD, reagent.
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- Alinity — Abbott · Class I
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 | 37017008ALSL008N | Class B | Active |
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Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (1)
- EUDAMED 9943ea55-841b-4627-b074-ac1064e19aad 61 fields · synced May 29, 2026