FDA Registration
Active
🇨🇳 China
SHENZHEN BESDATA TECHNOLOGY CO.,LTD
Reg #: 3014498758
·
FEI: 3014498758
·
Expires 2026
Products
8
Proprietary Names
7
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- SHENZHEN BESDATA TECHNOLOGY CO.,LTD
- Registration Number
- 3014498758
- FEI Number
- 3014498758
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 503, Building #2, Xinnantian Industrial Park, No. 3179, Danzi Avenue, Laokeng Community, Longtian Street, Pingshan District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K240074
Owner / Operator
- Firm Name
- SHENZHEN BESDATA TECHNOLOGY CO.,LTD
- Operator Number
- 10062317
- Address
- 503, Building #2, Xinnantian Industrial Park, No. 3179, Danzi Avenue, Laokeng Community, Longtian Street, Pingshan District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518129
- Country
- CN
- Correspondent
- Xiaohong Lu
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bottle, Collection, Vacuum | KDQ | Class 2 | General Hospital | No | 2026-06-15 |
| Instrument, Ent Manual Surgical | LRC | Class 1 | Ear, Nose, Throat | No | 2020-01-12 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2023-01-17 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2024-04-03 |
| Laryngostroboscope | EQL | Class 1 | Ear, Nose, Throat | No | 2020-01-12 |
| Choledochoscope And Accessories, Flexible/Rigid | FBN | Class 2 | Gastroenterology, Urology | No | 2024-11-18 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2024-11-18 |
| Accessories, Photographic, For Endoscope (Exclude Light Sources) | FEM | Class 1 | Gastroenterology, Urology | No | 2023-01-17 |
Proprietary Names
Stone Collector
Reusable blade,Disposable blade
Video otoscope,E-pocket
Disposable laryngoscope blade
Video rigid laryngoscope, Video laryngoscope, Video flexible laryngoscope, Video stylet scope
Single use flexible ureteroscope and accessories(image processor)
Image processor
Establishment Types
Manufacture Medical Device