Shanghai Sigma High-Tech Co., Ltd. is one of 1554 FDA 510(k) medical device manufacturers from China in the dataset, ranked by real submission volume.
Shanghai Sigma High-Tech Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD)
1
Total
1
Cleared
0
Denied
Shanghai Sigma High-Tech Co., Ltd. has 1 FDA 510(k) cleared medical devices. Based in Shanghai, CN.
Latest FDA clearance: Dec 2024. Active since 2024. Primary specialty: General & Plastic Surgery.
Browse the FDA 510(k) cleared devices submitted by Shanghai Sigma High-Tech Co., Ltd. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Microkn Medical Technology Service (Shanghai) Co., Ltd. as regulatory consultant.
FDA 510(k) Regulatory Record - Shanghai Sigma High-Tech Co., Ltd.
1 devices