Data / Medical devices / China / Shenzhen Besdata Technology Co.,ltd
Shenzhen Besdata Technology Co.,ltd: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
Shenzhen Besdata Technology Co.,ltd is registered with the FDA (registration 3014498758) in Shenzhen Guangdong, China. It lists 6 device types. The FDA files 1 510(k) clearance under its listings, the newest dated October 4, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014498758
- Address
- 401 and 503, Building #2, Xinnantian Industrial Park, No. 3179, Danzi Avenue Laokeng Community, Longtian Street, Pingshan District, Shenzhen Guangdong, China, 518129
- Owner or operator
- SHENZHEN BESDATA TECHNOLOGY CO.,LTD (10062317)
- Roles
- Manufacturer
- First device listed
- January 17, 2023
- Registered through
- 2026
- Brand names listed
- Image processor, ScopeRemote Medical scope, Single use flexible ureteroscope and accessories(image processor), Video laryngoscope,Disposable laryngoscope blade, Video otoscope,E-Pocket,VisionMate TriView ENT Exploration System with and without accessories
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Photographic, For Endoscope (Exclude Light Sources) | FEM | 1 | Manufacturer | accessdata.fda.gov |
| Choledochoscope And Accessories, Flexible/Rigid | FBN | 2 | Manufacturer | accessdata.fda.gov |
| Intraoral Camera | QJK | 2 | Manufacturer | accessdata.fda.gov |
| Laryngoscope, Rigid | CCW | 1 | Manufacturer | accessdata.fda.gov |
| Otoscope | ERA | 1 | Manufacturer | accessdata.fda.gov |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | 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 |
|---|---|---|---|---|---|---|
| October 4, 2024 | K240074 | Single use flexible ureteroscope (UR-D1); Single use flexible ureteroscope (UR-D2); Single use flexible ureteroscope (UR-F1); Single use flexible ureteroscope (UR-F2) | FGB | Substantially Equivalent | Shenzhen Besdata Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessories, Photographic, For Endoscope (Exclude Light Sources)
- All makers of Intraoral Camera
- All makers of Choledochoscope And Accessories, Flexible/Rigid
- All makers of Ureteroscope And Accessories, Flexible/Rigid
- All makers of Laryngoscope, Rigid
- All makers of Otoscope
Updated October 4, 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.