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Shanghai Seegen Photoelectric Technology Co., Ltd: FDA-registered device maker in Shanghai, China, 6 510(k) clearances

Shanghai Seegen Photoelectric Technology Co., Ltd is registered with the FDA (registration 3028058843) in Shanghai, China. It lists 7 device types. The FDA files 6 510(k) clearances under its listings, the newest dated January 30, 2026. Registered through 2027. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

FDA registration number
3028058843
Address
Building No.5, 4277 YinDu Road, Minhang District, 201108 Shanghai, PEOPLE'S REPUBLIC OF CHINA, Shanghai, China, 201108
Owner or operator
Shanghai SeeGen Photoelectric Technology Co., Ltd (10084506)
Roles
Manufacturer
First device listed
March 1, 2022
Registered through
2027
Brand names listed
Disposable Distal End Tape Hood, Disposable Endoscope Valves Kit, Flexible Video-Choledo-Cysto-Ureteroscope System, Flexible Video-Choledochoscope, Flexible Video-Choledochoscope System, Imaging Processor System (Including Light Source)

Devices it lists

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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
January 30, 2026K252457Disposable Distal End Tape HoodFDFSubstantially EquivalentShanghai SeeGen Photoelectric Technology Co., Ltd.accessdata.fda.gov
March 7, 2025K243535Flexible Video-Choledochoscope (CHV-110J-U); Flexible Video-Choledochoscope (CHV-US120J-U)FBNSubstantially EquivalentShanghai SeeGen Photoelectric Technology Co., Ltd.accessdata.fda.gov
October 22, 2024K241532Flexible Video-Choledo-Cysto-Ureteroscope System (PL-2100)FETSubstantially EquivalentShanghai SeeGen Photoelectric Technology Co., Ltd.accessdata.fda.gov
November 22, 2023K222499Disposable Endoscope Valves KitODCSubstantially EquivalentShanghai SeeGen Photoelectric Technology Co., Ltd.accessdata.fda.gov
April 20, 2023K222261Flexible Video-Choledochoscope SystemFBNSubstantially EquivalentShanghai SeeGen Photoelectric Technology Co., Ltd.accessdata.fda.gov
February 22, 2022K211686Flexible Video-Choledo-Cysto-Ureteroscope SystemFGBSubstantially EquivalentShanghai SeeGen Photoelectric Technology Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated January 30, 2026. 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.