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Accent-200 Alat

EUDAMED

Class IVD General (EU MDR)

Ref 7-216Model ACCENT-200 ALAT

by PZ CORMAY Spółka Akcyjna

Identity

Trade Name: ACCENT-200 ALAT EUDAMED
Device Name: ALAT EUDAMED
Model / Reference: ACCENT-200 ALAT EUDAMED
7-216 EUDAMED

Identifiers

Primary DI / UDI-DI: 05907514672165 EUDAMED
Basic UDI-DI: B-05907514672165 EUDAMED
EMDN Code: W01010103 ALANINE AMINO-TRANSFERASE EUDAMED

Classification

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

Accent-200 Alat by PZ CORMAY Spółka Akcyjna — 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: PZ CORMAY Spółka Akcyjna
EUDAMED SRN: PL-MF-000023053

Sources (1)

EUDAMED e4b3c648-e821-4af1-a00b-c0bb2b489636 61 fields · synced Oct 6, 2026