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Easyplus Mini R2N Self Monitoring Glucose Test System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K081796

by Eps Bio Technology Corp.

Identifiers

510(k) Number
K081796 FDA 510(k)
FDA Product Code
NBW FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 862.1345 FDA 510(k)
Regulation Number
862.1345 FDA 510(k)
Advisory Committee
Clinical Chemistry FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The device is a self-monitoring blood glucose system designed for measuring blood glucose levels. It is a glucose test system intended for self-monitoring by individuals with diabetes.

The system is supplied as a portable, compact, and lightweight device for regular use in home or clinical settings. It is authorized under FDA 510(k) clearance (K081796) and is intended for self-monitoring of blood glucose (SMBG).

Frequently asked questions

What is the EASYPLUS MINI R2N Glucose Test System used for?

The EASYPLUS MINI R2N is a self-monitoring blood glucose system designed for measuring blood glucose levels in individuals with diabetes, intended for regular use in home or clinical settings to support diabetes management.

How is the EASYPLUS MINI R2N system supplied and what makes it suitable for regular use?

The system is supplied as a portable, compact, and lightweight device, making it easy to carry and use regularly in home or clinical environments for self-monitoring of blood glucose by individuals with diabetes.

What regulatory authorization does the EASYPLUS MINI R2N have and what does it indicate?

The EASYPLUS MINI R2N is authorized under FDA 510(k) clearance (K081796), indicating it was found substantially equivalent to a legally marketed predicate device, allowing it to be legally marketed in the United States for its intended use.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: EPS Bio Technology EasyPlus mini R2N User Manual, Eps bio technology EasyPlus mini R2N Manuals | ManualsLib, EPS Bio Technology EasyPlus mini R2N : User`s manual, EPS Bio Technology EasyPlus mini R2N : User`s manual

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Eps Bio Technology Corp.

Sources (1)

  • FDA 510(k) K081796 24 fields · synced Sep 27, 2026