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Alt/Gpt

EUDAMED

Class IVD General (EU MDR)

Ref BT4193Ref 4193Ref 4194/50

by Giesse Diagnostics Srl

Identity

Trade Name: ALT/GPT EUDAMED
Device Name: ALT/GPT - Biotecnica Systems EUDAMED
ALT/GPT EUDAMED
Model / Reference: BT4193 EUDAMED
4193 EUDAMED
4194/50 EUDAMED

Identifiers

Primary DI / UDI-DI: 08053172972905 EUDAMED
08053172970116 EUDAMED
08053172970109 EUDAMED
Basic UDI-DI: B-08053172972905 EUDAMED
B-08053172970116 EUDAMED
B-08053172970109 EUDAMED
EMDN Code: W01010103 ALANINE AMINO-TRANSFERASE EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Italy 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

Alt/Gpt by Giesse Diagnostics Srl — Class IVD General — IVDD — 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/IVDD

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Manufacturer

Manufacturer: Giesse Diagnostics Srl
EUDAMED SRN: IT-MF-000039031

Sources (3)

EUDAMED 8018197f-89b8-454c-ba9d-712858274fbf 61 fields · synced Jul 20, 2026
EUDAMED 5b2c7836-3d18-4f25-90c9-92feef28f624 61 fields · synced May 18, 2026
EUDAMED 9666044b-af75-4f98-8913-bc11bd68a8ce 61 fields · synced May 19, 2026