Intended Use, Documents for Registration Purposes
The Accu-Chek Softclix, Accu-Chek Multiclix, Accu-Chek FastClix, and Autoclix products are intended to be used by one person only and shall not be used on multiple users. If someone else uses your lancing device there is an increased risk of cross infections.
Only the Single-Use Lancing Devices (SULDs) Accu-Chek Safe-T-Pro, Accu-Chek Safe-T-Pro Plus and Accu-Chek Safe-T-Pro Uno are intended for professional use, i.e. in care homes, doctor’s offices, hospitals, etc.
Only our SULDs, Accu-Chek Safe-T-Pro Plus and Accu-Chek Safe-T-Pro Uno, can be used on neonates (children younger than 1 year of age). For Safe-T-Pro Plus, only the two lowest depth settings, both of which have a penetration depth of below 2.0 mm, are suitable for neonatal use.
With children younger than 1 year of age (neonates), the capillary blood must be collected from the heel. Blood collection must occur from the lateral areas of the sole.
To collect capillary blood from the heel of children under 1 year, use only the low or medium penetration depth of the Accu-Chek Safe-T-Pro Plus device. If the high penetration depth is used, the calcaneus (heel bone) is at risk of being injured.
No, currently Roche does not offer any lancing devices especially for use on pets.
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]
For all registration inquiries, please contact the Roche Diabetes Care Registration Desk:
[email protected]
All Roche lancing systems are produced by external suppliers according to strict Roche quality standards. If you require more information on the production location of a specific lancing product, please contact the International Product Managers for Lancing:
[email protected]
[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