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Alanine aminotransferase (ALT/GPT) - single reagent
EUDAMEDClass IVD General (EU MDR)
Ref D-605 002Ref D-605 003
Identity
- Trade Name
- Alanine aminotransferase (ALT/GPT) - single reagent EUDAMED
- Device Name
- Alanine aminotransferase (ALT/GPT) - single reagent EUDAMED
- Model / Reference
- D-605 002 EUDAMEDD-605 003 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 62230182710170 EUDAMED62230182710248 EUDAMED
- Basic UDI-DI
- B-62230182710170 EUDAMEDB-62230182710248 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
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: Alanine aminotransferase (ALT) IVD, reagent
Alanine aminotransferase (ALT/GPT) - single reagent by Kalians Corporation — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Alanine aminotransferase (ALT) IVD, reagent.
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- 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-62230182710170 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Kalians Corporation
- EUDAMED SRN
- EG-MF-000050142
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (2)
- EUDAMED 2b6e68c9-c3fe-4269-a61d-98ad8cd3735f 61 fields · synced Jul 23, 2026
- EUDAMED 09a6ee65-4d6e-4fed-8099-06e964415150 61 fields · synced May 18, 2026