MEDIpoint and MEDIpoint International have been manufacturing and distributing medical products since 1957. Our products are used in 65 countries worldwide.MEDIpoint is a certified ISO 9001:2008 manufacturing facility with it's sterile medical devices also certified ISO 13485:2003. Our MEDIpoint Stainless Steel Blood Lancets and MEDIpoint's Splinter Out are certified for "CE" marking by the European Common Market. They comply completely with the European Medical Devices Directive 93/42/EEC and EN46002:1996 as well as the United States FDA Good Manufacturing Practice Regulations. They also comply with Health Canada's CMDCAS requirements.