← Back to catalogue
Alt/Gpt
EUDAMEDClass B (EU MDR)
Ref 1418-0087Ref 1415-0080Ref 1419-0082Ref 1419-0080Ref 1417-0087
Identity
- Trade Name
- ALT/GPT EUDAMED
- Device Name
- ALT/GPT EUDAMED
- Model / Reference
- 1418-0087 EUDAMED1415-0080 EUDAMED1419-0082 EUDAMED1419-0080 EUDAMED1417-0087 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05204309039845 EUDAMED05204309167197 EUDAMED05204309087440 EUDAMED05204309122899 EUDAMED05204309136742 EUDAMED
- Basic UDI-DI
- 5204309000007NQ EUDAMED
- EMDN Code
- W01010103 ALANINE AMINO-TRANSFERASE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Greece 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
New Device
No
EUDAMED
Category: Alanine aminotransferase (ALT) IVD, reagent
Alt/Gpt by Medicon Hellas SA — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Alanine aminotransferase (ALT) IVD, reagent.
- ALT (SGPT) LIQUID REAGENT (KINETIC METHOD) — TECO DIAGNOSTICS · Class I
- GPT LIQUID R1:4x36, R2:2x18 ml (GSAU) — Biotechnological Applications Ltd · IVD General
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
- Synermed® — INFRARED LABORATORY SYSTEMS LLC · Class I
- 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/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 5204309000007NQ | Class B | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Medicon Hellas SA
- EUDAMED SRN
- GR-MF-000013625
Sources (5)
- EUDAMED f144d35b-e6af-4f01-95a2-4ad51079e29d 61 fields · synced Aug 2, 2026
- EUDAMED c5de7958-6e1b-4380-ba97-15fc6948e386 61 fields · synced May 17, 2026
- EUDAMED 86b2e7dc-2b42-4a4c-bade-b5f8929bb56c 61 fields · synced May 17, 2026
- EUDAMED 1a477d79-420d-492d-9434-e8d22474e7ba 61 fields · synced May 18, 2026
- EUDAMED fde6ad8a-cbf2-4355-a0be-67de84d49559 61 fields · synced May 19, 2026