SBI Pharmaceuticals Co., Ltd. (Head office: Minato-ku, Tokyo; Representative Director & President:Yoshitaka Kitao; hereinafter “SBIP”), a subsidiary company of SBI Holdings, Inc. which conductsresearch and development pharmaceuticals, etc., utilizing 5-aminolevulinic acid (*) announces todaythat the medical light source device "Aladuck405/II" (hereafter “Aladuck”) marketed in Japan has beenregistered as a class II medical device with the U.S. FDA (Food and Drug Administration).
Prior to this, Aladuck has obtained “UL certification”, one of the most recognized safety standards inthe US electronics industry. In addition, Aladuck has obtained a conformity certificate “CB Report” byconducting safety tests on the device based on IEC (International Electrotechnical Commission)standards. These certifications have made it possible to obtain overseas certification easily andquickly.
Aladuck is a medical light source device that can be used in various surgical sites, as it canilluminate areas that are difficult to illuminate with conventional microscope light sources, and can beused together with a medical endoscope.SBIP will strive to fulfill Aladuck's worldwide needs and deliver them to wherever medical sites areneeded, both domestically and internationally.
