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Aspartate Aminotransferase Assay Kit (Malate Dehydrogenase Method)
EUDAMEDClass IVD General (EU MDR)
Ref DTSH020305Model R1: 20 mL×1; R2: 5 mL×1Ref DTSH020302Model R1: 60 mL×4; R2: 60 mL×1Ref DTSH020306Model R1: 40 mL×1; R2: 10 mL×1Ref DTSH020308Model R1: 40 mL×4; R2: 10 mL×4Ref DTSH020309Model R1: 60 mL×2; R2: 15 mL×2Ref DTSH020301Model R1: 60 mL×4; R2: 15 mL×4
Identity
- Device Name
- Aspartate Aminotransferase Assay Kit (Malate Dehydrogenase Method) EUDAMED
- Model / Reference
- R1: 20 mL×1; R2: 5 mL×1 EUDAMEDDTSH020305 EUDAMEDR1: 60 mL×4; R2: 60 mL×1 EUDAMEDDTSH020302 EUDAMEDR1: 40 mL×1; R2: 10 mL×1 EUDAMEDDTSH020306 EUDAMEDR1: 40 mL×4; R2: 10 mL×4 EUDAMEDDTSH020308 EUDAMEDR1: 60 mL×2; R2: 15 mL×2 EUDAMEDDTSH020309 EUDAMEDR1: 60 mL×4; R2: 15 mL×4 EUDAMEDDTSH020301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975225460738 EUDAMED06975225460790 EUDAMED06975225460745 EUDAMED06975225460769 EUDAMED06975225460776 EUDAMED06975225460783 EUDAMED
- Basic UDI-DI
- B-06975225460738 EUDAMEDB-06975225460790 EUDAMEDB-06975225460745 EUDAMEDB-06975225460769 EUDAMEDB-06975225460776 EUDAMEDB-06975225460783 EUDAMED
- EMDN Code
- W01010110 ASPARTATE AMINO-TRANSFERASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Netherlands 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
Category: Total aspartate aminotransferase (AST) IVD, reagent
Aspartate Aminotransferase Assay Kit (Malate Dehydrogenase Method) by Da Te Bioengineering Technology Co., LTD. — Class IVD General — IVDD — 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/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-06975225460738 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Da Te Bioengineering Technology Co., LTD.
- EUDAMED SRN
- CN-MF-000028832
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (6)
- EUDAMED 4e38b874-68ae-439e-bb0b-6d08db5c1114 61 fields · synced Sep 18, 2026
- EUDAMED 8530f50e-e011-4353-b9fa-765488202d86 61 fields · synced May 17, 2026
- EUDAMED b45acb4b-99b4-4640-9cc9-94e72d3c8dcd 61 fields · synced May 17, 2026
- EUDAMED fced1b30-3440-4d37-b0a4-4932300f36c0 61 fields · synced May 18, 2026
- EUDAMED 48da2f9a-dbfc-497b-b2c6-e57eff2fb7ad 61 fields · synced May 19, 2026
- EUDAMED cd9171b9-b546-4314-8a69-89464c471590 61 fields · synced May 19, 2026