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Alt/Gpt 4+1 Sl
EUDAMEDClass B (EU MDR)
Ref ALSL-0410Ref ALSL-5M90Ref ALSL-M490Ref ALSL-6255Ref ALSL-5220Ref ALSL-6M30Ref ALSL-6615
Identity
- Trade Name
- ALT/GPT 4+1 SL EUDAMEDALT/GPT EUDAMED
- Device Name
- ALT/GPT 4+1 SL EUDAMEDALT/GPT EUDAMED
- Model / Reference
- ALSL-0410 EUDAMEDALSL-5M90 EUDAMEDALSL-M490 EUDAMEDALSL-6255 EUDAMEDALSL-5220 EUDAMEDALSL-6M30 EUDAMEDALSL-6615 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701700815402 EUDAMED03701700800811 EUDAMED03701700800804 EUDAMED03701700815426 EUDAMED03701700815310 EUDAMED03701700800828 EUDAMED03701700815624 EUDAMED
- Basic UDI-DI
- 37017008ALSL008N EUDAMED37017008ALSL018Q 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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- ALANINE AMINOTRANSFERASE LIQUID KIT（IFCC METHOD） — DIRUI INDUSTRIAL CO., LTD · IVD General
- Alanine aminotransferase (ALT/GPT) - Liquizyme (4+1) — Egyptian Company For Biotechnology-Spectrum Diagnostics · IVD General
- 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 (7)
- EUDAMED 48263b81-8c65-465c-9a49-35c878199eb3 61 fields · synced Sep 18, 2026
- EUDAMED d0a5bb23-2102-4277-bdc3-ae394be1a519 61 fields · synced May 16, 2026
- EUDAMED e690e0f3-c216-46b1-9cc3-8ddcf035ed9d 61 fields · synced May 17, 2026
- EUDAMED 0c69e03f-0e7d-452d-bb94-6051bbf12810 61 fields · synced May 17, 2026
- EUDAMED 8f63524d-310f-4cf2-8210-b93df82c8fc3 61 fields · synced May 17, 2026
- EUDAMED 2fc9e59b-7c2e-4be2-b764-d6e46323f18f 61 fields · synced May 18, 2026
- EUDAMED a63b050f-9234-4d6e-813d-ecae9752bbf0 61 fields · synced May 18, 2026