Alanine Aminotransferase Liquid Kit（ifcc Method）

EUDAMED

Class IVD General (EU MDR)

Ref 3023197Model R1: 4x50mL, R2: 1x50mL

by Dirui Industrial Co., Ltd

Identity

Trade Name: ALANINE AMINOTRANSFERASE LIQUID KIT（IFCC METHOD） EUDAMED
Device Name: ALANINE AMINOTRANSFERASE LIQUID KIT（IFCC METHOD） EUDAMED
Model / Reference: R1: 4x50mL, R2: 1x50mL EUDAMED
3023197 EUDAMED

Identifiers

Primary DI / UDI-DI: 06942202212826 EUDAMED
Basic UDI-DI: B-06942202212826 EUDAMED
EMDN Code: W01010103 ALANINE AMINO-TRANSFERASE EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Austria 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 Liquid Kit（ifcc Method） by Dirui Industrial Co., Ltd — Class IVD General — CE/MDR — 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 (ALT/GPT) - Liquizyme (4+1) — Egyptian Company For Biotechnology-Spectrum Diagnostics · IVD General
Alinity — Abbott · Class I
Pointe Scientfic Inc. — POINTE SCIENTIFIC, INC. · 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	B-06942202212826	Class IVD General	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Dirui Industrial Co., Ltd
EUDAMED SRN: CN-MF-000001891
Authorised Representative: Emergo Europe B.V. NL-AR-000000116

Sources (1)

EUDAMED a982381d-838b-4c29-9d58-326d9d65d914 61 fields · synced Oct 6, 2026