EUDAMED last updated this device on Jul 27, 2026

AccuSure Life Plus Blood Glucose Monitoring System

B-06937339210906

On the marketIVDD — Annex II List B

Applicable legislation: —
Organization name: VivaChek Biotech (Hangzhou) Co., Ltd.
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 06937339210906
Reference / catalog number: VGM02-0Y1

Regulatory classification unavailableThis product's Basic UDI record hasn't been published in EUDAMED yet. Classification and compliance details will appear automatically once EUDAMED publishes it.

AccuSure Life Plus Blood Glucose Monitoring System is an IVDD-legacy in vitro diagnostic registered in EUDAMED. It is classified as IVDD — Annex II List B. Manufactured by VivaChek Biotech (Hangzhou) Co., Ltd.. Placed on the EU market in Türkiye. Explore certificates, regulatory status and the EUDAMED record on MD Atlas.

Device identification

Trade name: AccuSure Life Plus Blood Glucose Monitoring System
Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →: 06937339210906
Basic UDI-DI The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key. View in glossary →: B-06937339210906
Reference / catalog number: VGM02-0Y1
UDI issuing entities Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system. View in glossary →: GS1

Classification

Risk category: IVDD — Annex II List B
Applicable legislation: —
Status: On the market

Device details

Quantity: 1
Additional product description: The AccuSure Life Plus Blood Glucose Monitoring System is designed to quantitatively measure the glucose concentration in fresh whole blood. The AccuSure Life Plus blood glucose test is based on measurement of electrical current caused by the reaction of the glucose with the reagents on the electrode of the test strip. The blood sample is pulled into the tip of the test strip through capillary action. Glucose in the sample reacts with glucose enzyme and the mediator. Electrons are generated, producing a current that is positive correlation to the glucose concentration in the sample. After the reaction time, the glucose concentration in the sample is displayed. The meter is calibrated to display plasma-like concentration results. The AccuSure Life Plus system is intended for use outside the body (in vitro diagnostic use) by people with diabetes at home and health care professionals in clinical setting, as an aid to monitor the effectiveness of diabetes control. The system should not be used for diagnosis of diabetes.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

UDI-PI traceability

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UDI-DI DataMatrix

Encoded

(01)06937339210906

EMDN nomenclature code(s)

European Medical Device Nomenclature — the EU product classification assigned to this device.

W0201060102BLOOD GLUCOSE METERS

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

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Regulatory

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Lifecycle

New device

Market distribution

Primary placement in Türkiye; available across 1 country total.

Country	On market since	Until
TürkiyePrimary placement	Jan 1, 2025	Dec 31, 2027

AccuSure Life Plus Blood Glucose Monitoring System

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