Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3028058843

FEI Number

3028058843

Entity Name

SHANGHAI SEEGEN PHOTOELECTRIC TECHNOLOGY CO., LTD

City/State/Country

Shanghai, CN

Establishment Address

Building No.5, 4277 YinDu Road, Minhang District, 201108 Shanghai, PEOPLE'S REPUBLIC OF CHINA, Shanghai 201108, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shanghai SeeGen Photoelectric Technology Co., Ltd (Owner Number: 10084506)

Owner / Operator Contact Address

Building No.5, 4277 YinDu Road, Minhang District, 201108 Shanghai, PEOPLE'S REPUBLIC OF CHINA, Minhang District, Shanghai, CN-SH 201108, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211686

PMA Number

N/A

All Registered Proprietary Names

Flexible Video-Choledochoscope Imaging Processor System (Including Light Source) Flexible Video-Choledochoscope System Flexible Video-Choledo-Cysto-Ureteroscope System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-03-16
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2023-03-07
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2023-04-25
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2023-04-25
FET	Endoscopic Video Imaging System/Component, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2023-04-25
NTN	Led Light Source	Gastroenterology, Urology	Class 2	876.1500	2023-04-25
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2022-03-01
FBN	Choledochoscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-03-01
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2022-03-01

Official Correspondent

Li Wang

US Agent Details

Leeyeo Kee Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Shanghai SeeGen Photoelectric 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
3022106566	SHANGHAI SEEGEN PHOTOELECTRIC TECHNOLOGY CO., LTD	Shanghai, CN

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K915458	Psi Medical Products, Inc.	URETEROSCOPE	1992-01-30

Similar Registrations

Registration Number	Establishment Name	Location
3013992977	OTU Medical Inc	Union City, CA, US
3022106566	SHANGHAI SEEGEN PHOTOELECTRIC TECHNOLOGY CO., LTD	Shanghai, CN
2020550	KARL STORZ ENDOSCOPY-AMERICA, INC.	Auburn, MA, US
9610617	KARL STORZ SE & CO. KG	TUTTLINGEN Baden-Wurttemberg, DE
1221826	KARL STORZ ENDOVISION, INC.	CHARLTON, MA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3028058843. Last updated year: 2026. Please use registration number 3028058843 when referencing this establishment in official correspondence.