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Aspartate aminotransferase (AST/GOT) – Liquizyme (4+1)
EUDAMEDClass IVD General (EU MDR)
Ref 291 001Model 291 001 , ( 4 x 20 ml) 80 test
Identity
- Trade Name
- Aspartate aminotransferase (AST/GOT) – Liquizyme (4+1) EUDAMED
- Device Name
- Aspartate aminotransferase (AST/GOT) – Liquizyme (4+1) EUDAMED
- Model / Reference
- 291 001 , ( 4 x 20 ml) 80 test EUDAMED291 001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230041008714 EUDAMED
- Basic UDI-DI
- B-62230041008714 EUDAMED
- EMDN Code
- W01010110 ASPARTATE AMINO-TRANSFERASE EUDAMED
Classification
- Device Class
- Class IVD General 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
Category: Total aspartate aminotransferase (AST) IVD, reagent
Aspartate aminotransferase (AST/GOT) – Liquizyme (4+1) by Egyptian Company For Biotechnology-Spectrum Diagnostics — Class IVD General — CE/MDR — listed in…
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Also classified as Total aspartate aminotransferase (AST) IVD, reagent.
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- 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 | B-62230041008714 | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000032599
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED ee716ec1-5136-4da8-a4e0-ab3c281cebf5 61 fields · synced Oct 7, 2026