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Dongguan ZSR Biomedical Technology Company Limited: FDA-registered device maker in Dongguan Guangdong, China, 2 510(k) clearances

Name: Dongguan ZSR Biomedical Technology Company Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Dongguan ZSR Biomedical Technology Company Limited is registered with the FDA (registration 3016690337) in Dongguan Guangdong, China. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 11, 2025. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3016690337
Address: Unit 448,Qingfeng Road,Taihu Village,Sanzhong Village Committee,Qingxi Town,Dongguan City,Guangdong Province. PEOPLE'S REPUBLIC OF CHINA, Dongguan Guangdong, China, 523651
Owner or operator: Dongguan ZSR Biomedical Technology Company Limited (10092849)
Roles: Manufacturer
First device listed: February 26, 2025
Registered through: 2027
Brand names listed: Disposable Endoscope Stone Extractor (ZSR-SE01-1.7, ZSR-SE01-1.9, ZSR-SE02-1.3, ZSR-SE02-1.9, ZSR-SE02-2.2), Disposable Ureteral Guide Sheath (ZSR-UA-1035,ZSR-UA-1045,ZSR-UA-1135,ZSR-UA-1145,ZSR-UA-1235,ZSR-UA-1245,ZSR-UA-1335), Disposable Ureteral Guide Sheath (ZSR-UAC-1035A,ZSR-UAC-1040A,ZSR-UAC-1045A,ZSR-UAC-1050A,ZSR-UAC-1055A), Disposable Ureteral Guide Sheath (ZSR-UAC-1135A,ZSR-UAC-1140A,ZSR-UAC-1145A,ZSR-UAC-1150A,ZSR-UAC-1155A), Disposable Ureteral Guide Sheath (ZSR-UAC-1235A,ZSR-UAC-1240A,ZSR-UAC-1245A,ZSR-UAC-1250A,ZSR-UAC-1255A), Disposable Ureteral Guide Sheath (ZSR-UAC-1335A,ZSR-UAC-1340A,ZSR-UAC-1345A,ZSR-UAC-1350A,ZSR-UAC-1355A), Disposable Ureteral Guide Sheath (ZSR-UAC-1340,ZSR-UAC-1345,ZSR-UAC-1440,ZSR-UAC-1445), Disposable Ureteral Guide Sheath (ZSR-UAC-1435A,ZSR-UAC-1440A,ZSR-UAC-1445A,ZSR-UAC-1450A,ZSR-UAC-1455A) and more

Devices it lists

Device	Product code	Class	Role	Source
Dislodger, Stone, Basket, Ureteral, Metal	FFL	2	Manufacturer	accessdata.fda.gov
Endoscopic Access Overtube, Gastroenterology-Urology	FED	2	Manufacturer	accessdata.fda.gov
Endoscopic Guidewire, Gastroenterology-Urology	OCY	2	Manufacturer	accessdata.fda.gov
Ureteroscope And Accessories, Flexible/Rigid	FGB	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 11, 2025	K243155	Single-Use Digital Flexible Ureteroscope(F-URS) (ZSR-URS-01, ZSR-URS-02, ZSR-URS-03, ZSR-URS-04)	FGB	Substantially Equivalent	Dongguan Zsr Biomedical Technology Company Limited	accessdata.fda.gov
August 2, 2024	K241181	Disposable Ureteral Guide Sheath	FED	Substantially Equivalent	Dongguan Zsr Biomedical Technology Company Limited	accessdata.fda.gov

Compare with other makers

Updated February 11, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.