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Ast/Got 4+1 Sl
EUDAMEDClass B (EU MDR)
Ref ASSL-6255Model ASSL-0250Ref ASSL-6615Ref ASSL-6050Ref ASSL-5515Ref ASSL-5415Ref ASSL-5220
Identity
- Trade Name
- AST/GOT 4+1 SL EUDAMED
- Device Name
- AST/GOT 4+1 SL EUDAMED
- Model / Reference
- ASSL-0250 EUDAMEDASSL-6255 EUDAMEDASSL-6615 EUDAMEDASSL-6050 EUDAMEDASSL-5515 EUDAMEDASSL-5415 EUDAMEDASSL-5220 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03701700816126 EUDAMED03701700816324 EUDAMED03701700816027 EUDAMED03701700816317 EUDAMED03701700816119 EUDAMED03701700816010 EUDAMED
- Basic UDI-DI
- 37017008ASSL00B3 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 4+1 Sl 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 | 37017008ASSL00B3 | Class B | Active |
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Manufacturer
- Manufacturer
- VitalScientific
- EUDAMED SRN
- FR-MF-000004722
Sources (6)
- EUDAMED efa0f159-f1c7-465f-b0e8-688e8c4080b4 61 fields · synced Sep 18, 2026
- EUDAMED 7f45df6e-8b1f-40df-b453-cc91816174b3 61 fields · synced May 16, 2026
- EUDAMED 5136f3f3-a67c-4796-b1ec-533e4075bdc1 61 fields · synced May 17, 2026
- EUDAMED e5ff7836-8db6-4aed-acd4-1cdb49ec2a84 61 fields · synced May 17, 2026
- EUDAMED 7cb08305-6692-4924-9b7a-4dae05462b5d 61 fields · synced May 17, 2026
- EUDAMED 17673d32-07b7-4a01-ad78-444031da68c7 61 fields · synced Jul 19, 2026