Data / Medical devices / China / Shanghai Sigma High-Tech Co., Ltd.
Shanghai Sigma High-Tech Co., Ltd.: FDA-registered device maker in Shanghai, China, 1 510(k) clearance
Shanghai Sigma High-Tech Co., Ltd. is registered with the FDA (registration 3023306694) in Shanghai, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated December 19, 2024. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration 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, China, 201702
- Owner or operator
- Shanghai SIGMA High-tech Co., Ltd. (10094696)
- Roles
- Manufacturer
- First device listed
- December 17, 2025
- Registered through
- 2027
- Brand names listed
- UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD);, UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Light, Ultraviolet, Dermatological | FTC | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 19, 2024 | K242908 | UV Phototherapy Device (Group A: SQ308PCHFD, SQ308PCQFD, SQ308PCPFD, SQ308PCNFD, SQ308PCMFD); UV Phototherapy Device (Group B: SQ308PHTFF, SQ308PHSFF, SQ308PHRFF, SQ308PHZFG, SQ308PPUFF, SQ308PPVFF, SQ308PPWFG) | FTC | Substantially Equivalent | Shanghai Sigma High-Tech Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated December 19, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.