Entering the medical device market and developing a variety of products! Capable of meeting a wide range of needs.
Fukasawa Co., Ltd. manufactures medical devices and beauty equipment. We have been engaged in research and development of medical device products by collaborating and sharing information with major manufacturers, utilizing our expertise in compact and high-performance electronic circuit board technology. Leveraging this experience, we are here to meet our customers' needs and assist them. Please feel free to contact us with your requests. 【Strengths】 ■ ISO 13485 certified quality assurance system ■ Integrated manufacturing at our own factory ■ Registered as a medical device manufacturer with second-class manufacturing and sales license ■ Proven track record in assembly and repair of professional hair removal devices *For more details, please refer to the PDF document or feel free to contact us.
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basic information
【For concerns like these】 ■ It's the first time outsourcing the manufacturing of medical devices and beauty equipment ■ The current supplier is not meeting our requests ■ We do not have a manufacturing or repair facility for medical devices or beauty equipment *For more details, please refer to the PDF document or feel free to contact us.
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【Manufacturing Achievements】 ■ In-house developed "Periodontal Pocket Measuring Device" *For more details, please refer to the PDF document or feel free to contact us.
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Company information
Our company conducts integrated production in Shizuoka Prefecture, specializing in the assembly and manufacturing of electronic devices (from printed circuit board design to manufacturing, parts procurement, assembly, and control unit products), and we also accept orders for harness assemblies and universal boards. We excel in the assembly and repair of analytical devices and have received orders from major manufacturers. Since last year, we have entered the medical device industry and are focusing on contract manufacturing and research and development of medical devices. We are the manufacturer of our own medical device, the periodontal pocket measuring device, The P ken, with medical device certification number 231AMBZX00001000. We have obtained ISO 9001 and 14001 certification (2015 version), registered as a medical device manufacturer (22BZ200098), and have a second-class medical device manufacturing and sales license (22B2X10018). We have also obtained ISO 13485 certification (2016 version).
![[Example] Introduction of the process from 3D data *Medical device manufacturing license obtained](https://image.mono.ipros.com/public/product/image/a33/2000271640/IPROS605286323115971043.png?w=280&h=280)
