Alanine aminotransferase (ALT/GPT) - single reagent

EUDAMED

Class IVD General (EU MDR)

Ref 265 002Ref 265 001

by Egyptian Company For Biotechnology-Spectrum Diagnostics

Identity

Trade Name: Alanine aminotransferase (ALT/GPT) - single reagent EUDAMED
Device Name: Alanine aminotransferase (ALT/GPT) - single reagent EUDAMED
Model / Reference: 265 002 EUDAMED
265 001 EUDAMED

Identifiers

Primary DI / UDI-DI: 62230041000626 EUDAMED
62230041000558 EUDAMED
Basic UDI-DI: B-62230041000626 EUDAMED
B-62230041000558 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

EUDAMEDEUDAMED

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) - single reagent 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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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-62230041000626	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 (2)

EUDAMED 693b31cf-9b9f-47d4-8a7a-21767b5e2adf 61 fields · synced Oct 6, 2026
EUDAMED f3f0029d-3dbb-46b6-8536-10b29bc4fe1e 61 fields · synced May 18, 2026