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Alanine aminotransferase (ALT/GPT) - Colorimetric
EUDAMEDClass IVD General (EU MDR)
Ref 182 02 125
Identity
- Trade Name
- Alanine aminotransferase (ALT/GPT) - Colorimetric EUDAMED
- Device Name
- Alanine aminotransferase (ALT/GPT) - Colorimetric EUDAMED
- Model / Reference
- 182 02 125 EUDAMED
Identifiers
- Primary DI / UDI-DI
- G45818202125GN EUDAMED
- Basic UDI-DI
- B-G45818202125GN EUDAMED
- EMDN Code
- W01010103 ALANINE 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
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 (ALT/GPT) - Colorimetric by Spectrum for Diagnostic Industries (Joint Stock Company) — 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 LIQUID KIT（IFCC METHOD） — DIRUI INDUSTRIAL CO., LTD · 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-G45818202125GN | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000033954
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 61d9ab67-39e6-4498-93db-1a1d20339f82 61 fields · synced Oct 6, 2026