Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3036978610

FEI Number

3036978610

Entity Name

Zhuhai Pusen Medical Technology Co., Ltd.

City/State/Country

Zhuhai Guangdong, CN

Establishment Address

No. 1118, Jinrui Yi Road, High-tech Zone, Zhuhai Guangdong 519085, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Zhuhai Pusen Medical Technology Co., Ltd. (Owner Number: 10055280)

Owner / Operator Contact Address

No. 1118, Jinrui Yi Road, High-tech Zone, Zhuhai, CN-GD 519085, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K222602

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2024-07-28
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2024-07-28
PTS	Endoscopic Grasping/Cutting Instrument, Non-Powered, Exempt	Gastroenterology, Urology	Class 2	876.1500	2025-01-22
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2020-06-15
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-12-14
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-12-14
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2019-04-01
FAJ	Cystoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-09-27

Official Correspondent

Changshen Wang

US Agent Details

Keduo Yu Email: stephen.yu@pusenusa.com Phone: (678) 2005085

Related Public Records

Same Entity

Zhuhai Pusen Medical Technology Co., Ltd.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013687468	ZHUHAI PUSEN MEDICAL TECHNOLOGY CO, LTD	Zhuhai Guangdong, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K230752	FUJIFILM Healthcare Americas Corporation	Over-tube (TR-1208A); Over-tube (TR-1504A); Over-tube (TR-1507A)	2023-09-15
K915458	Psi Medical Products, Inc.	URETEROSCOPE	1992-01-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only

Similar Registrations

Registration Number	Establishment Name	Location
3044858680	JIENO YOUCHENG MEDICAL TECHNOLOGY (SHANGHAI) CO., LTD.	Shanghai, CN
3030511423	ZHEJIANG YIGAO MEDICAL TECHNOLOGY CO., LTD.	Hangzhou Zhejiang, CN
3011050570	Gyrus ACMI, Inc.	Brooklyn Park, MN, US
3035480112	SEPLOU (ZHUHAI) CO.,LTD.	Zhuhai Guangdong, CN
3012345110	Novadaq Technologies ULC	Burnaby British Columbia, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3036978610. Last updated year: 2026. Please use registration number 3036978610 when referencing this establishment in official correspondence.