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Hc-Alat

EUDAMED

Class IVD General (EU MDR)

Ref 4-516Model HC-ALAT

by PZ CORMAY Spółka Akcyjna

Identity

Trade Name: HC-ALAT EUDAMED
Device Name: ALAT EUDAMED
Model / Reference: HC-ALAT EUDAMED
4-516 EUDAMED

Identifiers

Primary DI / UDI-DI: 05907514645169 EUDAMED
Basic UDI-DI: B-05907514645169 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

Hc-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.

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 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 75da72ce-afa7-4b06-a1b2-33b75b16291a 61 fields · synced Jul 31, 2026