Shanghai Sigma High-Tech Co., Ltd.
ChinaFDA applicant, unverified FDA FEI 3023306694
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Shanghai Sigma High-Tech Co., Ltd. makes
Shanghai Sigma High-Tech Co., Ltd. manufactures UV phototherapy devices, including models for neonatal and pediatric use, designed to treat conditions such as neonatal jaundice and other phototherapy-responsive disorders. The devices are categorized into two groups based on specific configurations and applications, covering both full-body and localized treatment options.
The company’s UV phototherapy devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway in the United States. These devices are intended for medical use and comply with relevant regulatory requirements for phototherapy equipment.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3023306694
- Address
- The West Wing 1st FL, Building No.7&The East Wing 11th FL, Building No.8, No.388 Shuanglian Road, Xujing Town, Shanghai
Frequently asked questions
How many devices does Shanghai Sigma High-Tech Co., Ltd. have in the registry?
The registry currently lists 1 device for Shanghai Sigma High-Tech Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shanghai Sigma High-Tech Co., Ltd.'s devices?
Among its 1 most recently registered device, Shanghai Sigma High-Tech Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Shanghai Sigma High-Tech Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Shanghai Sigma High-Tech Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Shanghai Sigma High-Tech Co., Ltd. in the registry?
The most recently registered devices listed for Shanghai Sigma High-Tech Co., Ltd. include UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG).