Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016690337

FEI Number

3016690337

Entity Name

DONGGUAN ZSR BIOMEDICAL TECHNOLOGY COMPANY LIMITED

City/State/Country

Dongguan Guangdong, CN

Establishment Address

Unit 448,Qingfeng Road,Taihu Village,Sanzhong Village Committee,Qingxi Town,Dongguan City,Guangdong Province., PEOPLE'S REPUBLIC OF CHINA, Dongguan Guangdong 523651, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Dongguan ZSR Biomedical Technology Company Limited (Owner Number: 10092849)

Owner / Operator Contact Address

Unit 448,Qingfeng Road,Taihu Village,Sanzhong Village Committee,Qingxi Town,Dongguan City,Guangdong Province., PEOPLE'S REPUBLIC OF CHINA, Dongguan, CN-GD 523651, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K241181

PMA Number

N/A

All Registered Proprietary Names

Electronic Endoscope Imaging Processor (ZSR-EOS10) Single-Use Digital Flexible Ureteroscope (F-URS: ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04) Disposable Ureteral Guide Sheath

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FGB	Ureteroscope And Accessories, Flexible/Rigid	Gastroenterology, Urology	Class 2	876.1500	2025-02-26
FED	Endoscopic Access Overtube, Gastroenterology-Urology	Gastroenterology, Urology	Class 2	876.1500	2025-02-26

Official Correspondent

Sharon Wen

US Agent Details

Qihui Zhang Business: ZYPPEL LLC Email: Qzhang@Zyppel.Com Phone: (617) 2991655

Related Public Records

Same Entity

Dongguan ZSR Biomedical Technology Company Limited

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

View Entity Profile →

Related 510(k) Records

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016690337. Last updated year: 2026. Please use registration number 3016690337 when referencing this establishment in official correspondence.