Zhuhai Pusen Medical Technology Co., Ltd.
Manufacturer and brand owner in Zhuhai, Guangdong, China. 7 device types, 12 products catalogued, 7 clearances.
Zhuhai Pusen Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Laryngoscope, Rigid, Cystoscope And Accessories, Flexible/Rigid and 5 other device types. 12 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2017.
7device types registered with the FDA
12products catalogued under its own name
7510(k) clearances
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3036978610 |
| FEI number | 3036978610 |
| DUNS | 544427443 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 珠海普生医疗科技股份有限公司 |
|---|---|
| Unified social credit code | 91440400304040490D |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Zhuhai |
|---|---|
| Province | Guangdong |
| Address | No. 1118, Jinrui Yi Road, High-tech Zone |
| Postal code | 519085 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Choledochoscope And Accessories, Flexible/Rigid | Class 2 | Single use flexible video choledochoscope, PCH100-S, PCH111-S, Single use flexible video cystoscope, PC200-S, PC200-R, PC200-AS, PC200-AR, medical video endoscope image processor, Eview, PV300 | 2023 | 8 |
| Cystoscope And Accessories, Flexible/Rigid | Class 2 | Single Use Flexible Video Cystoscope (models: PC200-AR, PC200-AS, PC200-R, PC200-S), HD Medical Video Endoscope Image Processor (models: PV300, PVX800), Single use flexible video choledochoscope, PCH100-S, PCH111-S, Single use flexible video cystoscope, PC200-S, PC200-R, PC200-AS, PC200-AR, medical video endoscope image processor, Eview, PV300 | 2022 | 16 |
| Endoscopic Access Overtube, Gastroenterology-Urology | Class 2 | ClearEVAC Ureteral Aspirating Access Sheath, US-100-1040,US-100-1050,US-100-1240,US-100-1250, 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, 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 | 2024 | 19 |
| Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt | Class 2 | Single use grasping forceps; Single use biopsy forceps; PGA; PGB | 2025 | 21 |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | Class 2 | Eview, PV210, PV220, medical video endoscope image processor | 2019 | 8 |
| Laryngoscope, Rigid | Class 1 | single use video laryngoscope, BL100 | 2020 | 44 |
| Ureteroscope And Accessories, Flexible/Rigid | Class 2 | medical video endoscope image processor, Eview, UTV100, Single use flexible video ureteroscope, PU3033A-S, PU3033A-R, PU3022A, PU3022, 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, 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 | 2017 | 21 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Uscope | FGB | 23 |
| Single Use Video Ureteroscope Direct In-Scope Suction | FGB | 12 |
| Single Use Flexible Video Cystoscope | FAJ | 4 |
| Single Use Flexible Video Ureteroscope | FGB | 4 |
| Eview | FET | 3 |
| Eview | FAJ | 3 |
| Pocket Monitor | FET | 1 |
| Single use grasping forceps PGA | PTS | 1 |
| Single-use Video Laryngoscope | CCW | 1 |
| Eview | FGB | 1 |
| Single use biopsy forceps PGB | PTS | 1 |
| Foot Switch (HRF-M5 PS) | FAJ | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K260521 | 2026-04-06 | FED | Traditional | This company |
| K233778 | 2024-07-16 | FGB | Traditional | This company |
| K223741 | 2023-06-22 | FBN | Traditional | This company |
| K222602 | 2022-09-26 | FAJ | Traditional | This company |
| K190648 | 2019-03-29 | FET | Traditional | This company |
| K172098 | 2017-08-31 | FGB | Traditional | This company |
| K171076 | 2017-05-05 | FGB | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2014 |
|---|---|
| Employees | 200+ |
| Factory area | 8,500 sq meters |
| Main products | single-use flexible ureteroscope, image processor, urology equipment, airway management |
| Certifications | ICP |
| Export markets | Global |
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.
The manufacturer named here can complete this record.