SimplexTAS 101 UA Reagent Cartridge

EUDAMED

Class IVD General (EU MDR)

Ref T0101023

by tascom co., ltd.

Identity

Device Name: SimplexTAS 101 UA Reagent Cartridge EUDAMED
Model / Reference: T0101023 EUDAMED

Identifiers

Primary DI / UDI-DI: 08800037901217 EUDAMED
Basic UDI-DI: B-08800037901217 EUDAMED
EMDN Code: W01010232 URIC ACID 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

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Category: Uric acid IVD, reagent

SimplexTAS 101 UA Reagent Cartridge by tascom co., ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

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
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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

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	B-08800037901217	Class IVD General	Active

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Manufacturer

Manufacturer: tascom co., ltd.
EUDAMED SRN: KR-MF-000019000
Authorised Representative: Medical Technology Promedt Consulting GmbH DE-AR-000000085

Sources (1)

EUDAMED 60066755-8548-4984-9e8c-4232285d25de 61 fields · synced Aug 2, 2026