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Uric Acid（UA）Assay Kit (Uricase Method)

EUDAMED

Class IVD General (EU MDR)

Ref R: 2×60 mL

by Shenzhen AmTech Bioengineering Ltd., Inc.

Identity

Device Name: Uric Acid（UA）Assay Kit (Uricase Method) EUDAMED
Model / Reference: R: 2×60 mL EUDAMED

Identifiers

Primary DI / UDI-DI: 06937287300063 EUDAMED
Basic UDI-DI: B-06937287300063 EUDAMED
EMDN Code: W01010232 URIC ACID EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Austria 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: Uric acid IVD, reagent

Uric Acid（UA）Assay Kit (Uricase Method) by Shenzhen AmTech Bioengineering Ltd., Inc. — Class IVD General — IVDD — listed in EUDAMED

Similar devices

Also classified as Uric acid IVD, reagent.

URIC ACID REAGENT KIT（URICASE METHOD） — DIRUI INDUSTRIAL CO., LTD · IVD General
BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
Uric Acid (UA) — Maccura Biotechnology Co., Ltd. · IVD General
Liquick Cor-UA 120 — PZ CORMAY Spółka Akcyjna · IVD General
URIC ACID Kit — KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ · IVD General
BIOBASE — Biobase Biodustry(Shandong)Co., Ltd. · Class I
JAS Diagnostics — Drew Scientific , Ltd. · Class I
Uric acid — Kalians Corporation · IVD General

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer: Shenzhen AmTech Bioengineering Ltd., Inc.
EUDAMED SRN: CN-MF-000043067
Authorised Representative: SUNGO Europe B.V. NL-AR-000000247

Sources (1)

EUDAMED fced6767-0cca-4095-aca6-c37baf026a9e 61 fields · synced Jun 19, 2026