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ALT (GPT), 10 x 10 mL

EUDAMED

Class IVD General (EU MDR)

Ref 101-0255

by Chronolab Systems, S.L.

Identity

Trade Name: ALT (GPT), 10 x 10 mL EUDAMED
Device Name: ALT (GPT), 10 x 10 mL EUDAMED
Model / Reference: 101-0255 EUDAMED

Identifiers

Primary DI / UDI-DI: D-084360385835831HF EUDAMED
Basic UDI-DI: B-084360385835831HF EUDAMED
EMDN Code: W01010103 ALANINE AMINO-TRANSFERASE EUDAMED

Classification

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

No

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Category: Alanine aminotransferase (ALT) IVD, reagent

ALT (GPT), 10 x 10 mL by Chronolab Systems, S.L. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Alanine aminotransferase (ALT) IVD, reagent.

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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: Chronolab Systems, S.L.
EUDAMED SRN: ES-MF-000017043

Sources (1)

EUDAMED be293da7-1aa7-4b1c-99c6-88d386ce4e3a 61 fields · synced Jul 14, 2026