FDA Registration
Active
🇨🇳 China
Zhuhai Pusen Medical Technology Co., Ltd.
Reg #: 3036978610
·
FEI: 3036978610
·
Expires 2026
Products
7
Proprietary Names
19
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- Zhuhai Pusen Medical Technology Co., Ltd.
- Registration Number
- 3036978610
- FEI Number
- 3036978610
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 1118, Jinrui Yi Road, High-tech Zone
- City
- Zhuhai Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K233778
Owner / Operator
- Firm Name
- Zhuhai Pusen Medical Technology Co., Ltd.
- Operator Number
- 10055280
- Address
- No. 1118, Jinrui Yi Road, High-tech Zone
- City
- Zhuhai
- State
- Guangdong
- Postal Code
- 519085
- Country
- CN
- Correspondent
- Changshen Wang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoscopic Access Overtube, Gastroenterology-Urology | FED | Class 2 | Gastroenterology, Urology | No | 2024-07-28 |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | Class 2 | Gastroenterology, Urology | No | 2024-07-28 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | PTS | Class 2 | Gastroenterology, Urology | No | 2025-01-22 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2020-06-15 |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | Class 2 | Gastroenterology, Urology | No | 2023-12-14 |
| Choledochoscope And Accessories, Flexible/Rigid | FBN | Class 2 | Gastroenterology, Urology | No | 2023-12-14 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | Class 2 | Gastroenterology, Urology | No | 2019-04-01 |
Proprietary Names
PU630A-S, PU630A-R, PU632A-S, PU632A-R Single Use Video Ureteroscope Direct In-Scope Suction
PU631A-S, PU631A-R, PU633A-S, PU633A-R Single Use Flexible Video Ureteroscope
PU400A-S, PU400A-R, PU411A-S, PU411A-R Single Use Video Ureteroscope Direct In-Scope Suction
PU3033AH-S, PU3033AH-R, PU3033H-S, PU3033H-R Single Use Video Ureteroscope Direct In-Scope Suction
Single use grasping forceps; Single use biopsy forceps; PGA; PGB
single use video laryngoscope
BL100
medical video endoscope image processor, Eview, PV300
Single use flexible video cystoscope, PC200-S, PC200-R, PC200-AS, PC200-AR
Single use flexible video choledochoscope, PCH100-S, PCH111-S
medical video endoscope image processor
Eview
PV210, PV220
HD Medical Video Endoscope Image Processor, PV300
Single use flexible video cystoscope, PC200-AR, PC200-AS, PC200-R, PC200-S
Single use flexible video ureteroscope, PU3033A-S, PU3033A-R, PU3022A, PU3022
medical video endoscope image processor, Eview, UTV100
ClearEVAC Ureteral Aspirating Access Sheath
US-100-1040,US-100-1050,US-100-1240,US-100-1250
Establishment Types
Manufacture Medical Device