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Aspartate Aminotransferase Kit (IFCC Method)
EUDAMEDClass B (EU MDR)
Ref 105-000854-00Model 105-000815-00、105-000854-00、105-004592-00Ref 105-000815-00
Identity
- Trade Name
- Aspartate Aminotransferase Kit (IFCC Method) EUDAMED
- Device Name
- Aspartate Aminotransferase Kit (IFCC Method) EUDAMED
- Model / Reference
- 105-000815-00、105-000854-00、105-004592-00 EUDAMED105-000854-00 EUDAMED105-000815-00 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06944904025100 EUDAMED06944904024714 EUDAMED
- Basic UDI-DI
- 694490400041AST********PT EUDAMED
- EMDN Code
- W01010110 ASPARTATE AMINO-TRANSFERASE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Aspartate Aminotransferase Kit (IFCC Method) by Shenzhen Mindray Bio-Medical Electronics Co., LTD — Class B — IVDR — listed in EUDAMED
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 | 694490400041AST********PT | Class B | Active |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
- EUDAMED SRN
- CN-MF-000014156
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (2)
- EUDAMED 92ebd36c-8f8c-4417-bca9-36927994a78b 61 fields · synced Jul 20, 2026
- EUDAMED 36af91a1-4ba0-4571-932c-cf36f903798b 61 fields · synced May 18, 2026