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FAQ Listing

Roche Diabetes Care, as a manufacturer of medical devices, certified to European standards, complies with all applicable European directives. The lancing device is CE (Conformité Européene) labeled, which means that the product meets the safety and normative requirements of those European directives. The European regulations are valid and recognized under mutual recognition agreements with many countries, including Canada, LATAM, APAC and Japan. The lancing device also complies with laws such as the US Needlestick Safety and Prevention Act, the TRBA 250 (Germany) or the NR 32 (Brazil) and others.
In Poland.
200 units
No. (For a list of materials please contact Roche Diabetes Care, Mannheim, Germany.)
If stored properly, the lancing device remains functional for 4 years after sterilization.
If stored properly, the lancets remain sterile for 4 years after sterilization.
The lancets (needles surrounded by the sterility cap) of the device are sterilized in a process called gamma irradiation which meets the international standards.
The lancing device should be disposed of in accordance with your facility’s disposable procedures.
Yes. It is suitable for use with children under 1 year of age and neonates.
No. The lancing device is not designed and intended to be used for AST.
No. The lancing device has a uniquely designed and engineered safety mechanism. The release button is depressed and locked in the housing after use.