Alanine aminotransferase (ALT/GPT) - Liquizyme (4+1)

EUDAMED

Class IVD General (EU MDR)

Ref 292 002

by Egyptian Company For Biotechnology-Spectrum Diagnostics

Identity

Trade Name: Alanine aminotransferase (ALT/GPT) - Liquizyme (4+1) EUDAMED
Device Name: Alanine aminotransferase (ALT/GPT) - Liquizyme (4+1) EUDAMED
Model / Reference: 292 002 EUDAMED

Identifiers

Primary DI / UDI-DI: 62230041001616 EUDAMED
Basic UDI-DI: B-62230041001616 EUDAMED
EMDN Code: W01010103 ALANINE AMINO-TRANSFERASE EUDAMED

Classification

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

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Category: Alanine aminotransferase (ALT) IVD, reagent

Alanine aminotransferase (ALT/GPT) - Liquizyme (4+1) 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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BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
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ALANINE AMINOTRANSFERASE LIQUID KIT（IFCC METHOD） — DIRUI INDUSTRIAL CO., LTD · IVD General
ALANINE AMINOTRANSFERASE LIQUID KIT（IFCC METHOD） — DIRUI INDUSTRIAL CO., LTD · 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-62230041001616	Class IVD General	Active

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Manufacturer

Manufacturer: Egyptian Company For Biotechnology-Spectrum Diagnostics
EUDAMED SRN: EG-MF-000032599
Authorised Representative: MDSS GmbH DE-AR-000005430

Sources (1)

EUDAMED 347dddf7-ace8-4d35-96aa-e4329c88e44b 61 fields · synced Oct 5, 2026