Identity
- Trade Name
- AST/GOT EUDAMED
- Device Name
- AST/GOT EUDAMED
- Model / Reference
- ASSL-M490 EUDAMEDASSL-6M30 EUDAMEDASSL-5M90 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701700801429 EUDAMED03701700801405 EUDAMED03701700801412 EUDAMED
- Basic UDI-DI
- 37017008ASSL01B5 EUDAMED
- EMDN Code
- W01010110 ASPARTATE 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: Total aspartate aminotransferase (AST) IVD, reagent
Ast/Got by Vitalscientific — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Total aspartate aminotransferase (AST) IVD, reagent.
- GOT (AST) — Cypress Diagnostics · IVD General
- ASPARTATE AMINOTRANSFERASE REAGENT KIT（IFCC METHOD） — DIRUI INDUSTRIAL CO., LTD · IVD General
- AST (SGOT) Kit — KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ · IVD General
- GOT LIQUID R1:4x40, R2:2x20 ml (ΗΙΤ) — Biotechnological Applications Ltd · IVD General
- Aspartate Aminotransferase Kit( IFCC Method) — Coei Biotech Co.Ltd. · IVD General
- Aspartate Aminotransferase (AST) — KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class II
- aminotransferase — C.P.M. COMPAGNIA PER LA MEDICINA S.R.L. · IVD General
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 | 37017008ASSL01B5 | 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 e66ec40c-545c-4227-b27f-f1d50a8df663 61 fields · synced Jul 10, 2026
- EUDAMED aa7561d7-3763-4658-b2a9-b3ddaf3a2c4f 61 fields · synced May 17, 2026
- EUDAMED ba08b708-dfe1-4457-b33f-b39df6036660 61 fields · synced May 18, 2026