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Alanine aminotransferase (ALT/GPT) - single reagent
EUDAMEDClass IVD General (EU MDR)
Ref 265003
Identity
- Trade Name
- Alanine aminotransferase (ALT/GPT) - single reagent EUDAMED
- Device Name
- Alanine aminotransferase (ALT/GPT) - single reagent EUDAMED
- Model / Reference
- 265003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230041000794 EUDAMED
- Basic UDI-DI
- B-62230041000794 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) - single reagent by Egyptian Company For Biotechnology-Spectrum Diagnostics — Class IVD General — IVDD — listed in EUDAMED
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Also classified as Alanine aminotransferase (ALT) IVD, reagent.
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- Alinity — Abbott · Class I
- Pointe Scientfic Inc. — POINTE SCIENTIFIC, INC. · 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-62230041000794 | Class IVD General | Active |
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Manufacturer
- EUDAMED SRN
- EG-MF-000032599
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED 1d166b2c-9022-475b-8795-8a6b90e34ce6 61 fields · synced Jun 17, 2026