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Alanine Aminotransferase Reagent Kit
EUDAMEDClass IVD General (EU MDR)
Ref ALT6011Y, ALT6012Y, ALT6013Y, ALT6014Y, ALT6015Y, ALT6011N, ALT6012N, ALT6013N, ALT6014N, ALT6015N
Identity
- Trade Name
- Alanine Aminotransferase Reagent Kit EUDAMED
- Device Name
- Alanine Aminotransferase Reagent Kit EUDAMED
- Model / Reference
- ALT6011Y, ALT6012Y, ALT6013Y, ALT6014Y, ALT6015Y, ALT6011N, ALT6012N, ALT6013N, ALT6014N, ALT6015N EUDAMED
Identifiers
- Primary DI / UDI-DI
- D-ALT601B8 EUDAMED
- Basic UDI-DI
- B-ALT601B8 EUDAMED
- EMDN Code
- W01010103 ALANINE AMINO-TRANSFERASE EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
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: Alanine aminotransferase (ALT) IVD, reagent
Alanine Aminotransferase Reagent Kit by Hangzhou Aichek Medical Technology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED
Similar devices
Also classified as Alanine aminotransferase (ALT) IVD, reagent.
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- ALANINE AMINOTRANSFERASE LIQUID KIT（IFCC METHOD） — DIRUI INDUSTRIAL CO., LTD · IVD General
- Alanine aminotransferase (ALT/GPT) - Liquizyme (4+1) — Egyptian Company For Biotechnology-Spectrum Diagnostics · IVD General
- Alinity — Abbott · Class I
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-ALT601B8 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Hangzhou Aichek Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000028093
- Authorised Representative
- Medunion S.L. ES-AR-000019366
Sources (2)
- EUDAMED af4413b6-dee5-4d4a-9e46-f682c215adca 61 fields · synced Jul 9, 2026
- EUDAMED af4413b6-dee5-4d4a-9e46-f682c215adca-1 61 fields · synced Jun 9, 2026