About Brightstone
About Brightstone
About Us
About Us
Shanghai Brightstone Medical Technology Limited. is a professional manufacturer specializing in various types of medical puncture instruments, medical electrodes, therapeutic instruments and their accessories. The company's management team is composed of professionals with decades of experience in design, manufacturing, and management in the industry. At the beginning of its establishment, the company aimed at international high-end markets such as the United States and Europe, established a sound quality management system internally, and passed the 1S0 13485 international medical device quality management system certification. At the same time, medical needles and electrodes, such as disposable radiofrequency needles, radiofrequency electrodes, disposable spinal needles, and epidural needles, developed and manufactured with high starting points, high requirements, and high quality, have successively obtained market access approvals and certificates from the United States and the European Community. They have been continuously sold to the US and European markets for many years and can be comparable to similar products in the US and European markets.
On this basis, the company is willing to use our decades of accumulated professional technology and experience to wholeheartedly provide customized services for various medical puncture cannulas and cores, including bone marrow biopsy, soft tissue biopsy, cell biopsy, interventional therapy, minimally invasive treatment, nerve block, infusion drainage, medical cosmetology, etc., for domestic medical device peers. We also welcome customized high-precision or special purpose stainless steel metal capillaries required by various industries such as aerospace, instrumentation, and electronics according to drawings and samples.
Development History
Development History
2015 ——
Brightstone Medical Technology was officially established, embarking on a journey of innovation and expansion in medical technology.
Brightstone Medical Technology was officially established, embarking on a journey of innovation and expansion in medical technology.
0216 ——
Completed the independent research and development of disposable and reusable radiofrequency electrodes, obtained the U.S. FDA 510K approval, and secured the international ISO 13485 system certification.
Completed the independent research and development of disposable and reusable radiofrequency electrodes, obtained the U.S. FDA 510K approval, and secured the international ISO 13485 system certification.
2017 ——
Obtained the CE certificates for disposable and reusable radiofrequency electrodes as well as disposable radiofrequency needles.
Obtained the CE certificates for disposable and reusable radiofrequency electrodes as well as disposable radiofrequency needles.
2018 ——
The production bases for medical needles such as disposable lumbar puncture needles and epidural needles, as well as disposable and reusable radiofrequency electrodes, were completed and put into operation. Products fully entered the U.S. and European markets.
The production bases for medical needles such as disposable lumbar puncture needles and epidural needles, as well as disposable and reusable radiofrequency electrodes, were completed and put into operation. Products fully entered the U.S. and European markets.
2019 ——
Received innovation fund grants from the Science and Technology Commissions of Shanghai Municipality and the district.
Received innovation fund grants from the Science and Technology Commissions of Shanghai Municipality and the district.
2021 ——
The production base was expanded, significantly increasing export production capacity and enhancing domestic medical needle OEM service capabilities.
The production base was expanded, significantly increasing export production capacity and enhancing domestic medical needle OEM service capabilities.
2023 ——
Obtained the High-Tech Enterprise certificate.
Obtained the High-Tech Enterprise certificate.
2025 ——
Obtained the national invention patent certificate for a combined multifunctional radiofrequency ablation and thermocoagulation electrode.
Obtained the national invention patent certificate for a combined multifunctional radiofrequency ablation and thermocoagulation electrode.
2026 ——
Obtained the domestic medical device product registration certificate and production license for disposable radiofrequency electrodes.
Obtained the domestic medical device product registration certificate and production license for disposable radiofrequency electrodes.
Qualification Certificate
Qualification Certificate