Shenzhen Besdata Technology Co., Ltd.
Registered establishment in Shenzhen, Guangdong, China. 6 device types, 1 clearance.
Shenzhen Besdata Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Otoscope, Intraoral Camera and 4 other device types. Its earliest product listing with the FDA dates from 2023.
6device types registered with the FDA
1510(k) clearance
Registration
| Registered name | SHENZHEN BESDATA TECHNOLOGY CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3014498758 |
| FEI number | 3014498758 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳柏德医疗科技有限公司 |
|---|---|
| Unified social credit code | 91440300MA5DNNND9H |
| Source | provincial manufacturer licence lists |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 503, Building #2, Xinnantian Industrial Park, No. 3179, Danzi Avenue |
| Postal code | 518129 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessories, Photographic, For Endoscope (Exclude Light Sources) | Class 1 | Image processor | 2023 | 8 |
| Choledochoscope And Accessories, Flexible/Rigid | Class 2 | Single use flexible ureteroscope and accessories(image processor) | 2024 | 8 |
| Intraoral Camera | Class 2 | Medical scope | 2026 | 6 |
| Laryngoscope, Rigid | Class 1 | Video laryngoscope,Disposable laryngoscope blade | 2024 | 44 |
| Otoscope | Class 1 | Video otoscope,E-Pocket,VisionMate TriView ENT Exploration System with and without accessories, Medical scope | 2023 | 43 |
| Ureteroscope And Accessories, Flexible/Rigid | Class 2 | Single use flexible ureteroscope and accessories(image processor) | 2024 | 21 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K240074 | 2024-10-04 | FGB | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2016 |
|---|---|
| Factory area | 3,000 square meters |
| Main products | Video laryngoscope, Medical endoscopes, EEG electrodes, Bronchoscope, Video otoscope |
| Certifications | FDA, CE-MDR, CFDA, ANVISA, ISO 13485 |
| Export markets | USA, EU, Mexico, Brazil, Thailand, Egypt, Iran, Turkey, Argentina, Vietnam, Russia, Iraq |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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