Lancet & Lancing Device - India CDSCO Medical Device Registration

Product Information

The Accu-Chek® Softclix is a lancing system for capillary blood sampling for diagnostic purposes (Accu-Chek Softclix kit) in home-use areas (Accu-Chek Softclix kit). Lancing Device: The Accu‑Chek Softclix lancing device is a device for simple, virtually pain-free collection of capillary blood from the fingertips. The Accu‑Chek Softclix lancing Device is intended for single patient use only! It is only allowed to be used to obtain blood from one person. There is a risk of infections being transmitted if the lancing device is used by other people, even by family members, or if healthcare professionals use this lancing device to obtain blood from different people. This lancing device is therefore not suitable for professional use in healthcare facilities and institutions. It is not a sterile product. People in the area of diabetes self-monitoring are considered as target group. Lancets: The Accu‑Chek Softclix lancet and the Accu‑Chek Softclix XL lancet are sterile single-lancets and are intended to be used with the Accu‑Chek Softclix lancing device for simple, virtually pain-free collection of capillary blood. The lancet is a disposable article intended to be used only once each. Each lancet has a protective cap that guarantees sterile condition until its first use. The lancets are sterilized using irradiation.