2in1 Max Blood Glucose Test Strips

Trade name

2in1 Max Blood Glucose Test Strips

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

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06937339206923

Basic UDI-DI

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.

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B-06937339206923

Reference / catalog number

VGS02-036

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

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GS1

Risk category

IVDD — Annex II List B

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The 2in1. MaX Blood Glucose Test Strips are thin strips with a chemical reagent system. They work with the 2in1. Max and MaX BT Blood Glucose Meters as a system to quantitatively measure the glucose concentration in fresh capillary whole blood. The 2in1. MaX / MaX BT blood glucose test is based on measurement of electricaI 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 2ir1. Max and MaX BT Blood Glucose Monitoring Systems are fully complying with the new EN ISO 15197:2015 International Standard. The 2in1. MaX Blood Glucose Test Strips and 2in1. Max and MaX BT Blood Glucose Meters are intended for use outside the body (in vitro diagnostic use) for self-testing and health care professional use, as an aid to monitor the effectiveness of diabetes control. The system should not be used for diagnosis of diabetes. Professionals may also test neonatal, venous and arterial blood samples.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• W0101060101GLUCOSE TEST STRIPS

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

• CW010

  EUDAMED did not publish a description for this code.

No certificate specifically references this device's Basic UDI-DI.