Intended Use, Documents for Registration Purposes
What requirements do the Accu-Chek lancing systems and SULDs meet?
Roche Diabetes Care GmbH, as a manufacturer of medical devices, certified to European standards, complies with all applicable European directives.
The lancing devices, lancets/lancet drums and SULDs are CE labeled (Conformité Européene), 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.
For more information, please contact the Roche Diabetes Care Registration Desk:
[email protected]
Other categories
Check other FAQ categories by clicking on the below category names.
- General questions
- Accuracy
- Test strips
- Getting started
- Launch Dates
- Specifications
- Meter Settings
- General Use
- Data
- Connectivity
- Chemistry
- Blood Sample
- Strip Container
- Control - Linearity Solutions
- Interferences - Limitations
- Digital Solution Compatibility
- Product Materials, Bill of Materials
- Hygiene, Sterility, Lancet Reuse, Disposal of Used Consumables
- Needle, Lancet
- Lancing Depth, Depth Settings
- Alternative Site Testing (AST)
- Clixmotion Technology
- 1-Click Lancing
- Lancing - Steps, Helpful Information
- Patents, Generics, Counterfeits