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Data / Medical devices / China / Hangzhou Jimushi Meditech Co., Ltd.

Hangzhou Jimushi Meditech Co., Ltd.: FDA-registered device maker in Hangzhou Zhejiang, China, 3 510(k) clearances

Hangzhou Jimushi Meditech Co., Ltd. is registered with the FDA (registration 3016863553) in Hangzhou Zhejiang, China. It lists 6 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 24, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number
3016863553
Address
Floors 1-3, Building 1, NO. 3 Wangtai Road Zhongtai Street, Yuhang District, Hangzhou Zhejiang, China, 311121
Owner or operator
Hangzhou Jimushi Meditech Co.,Ltd (10075894)
Roles
Contract manufacturer, Manufacturer
First device listed
June 30, 2020
Registered through
2027

Devices it lists

DeviceProduct codeClassRoleSource
Catheter Care TrayOHR2Contract manufactureraccessdata.fda.gov
Catheter, StraightEZD2Contract manufacturer, Manufactureraccessdata.fda.gov
Catheter, UrethralGBM2Manufactureraccessdata.fda.gov
Catheter, UrologicalKOD2Contract manufactureraccessdata.fda.gov
Device, Intravascular Catheter SecurementKMK1Manufactureraccessdata.fda.gov
Holder, Ureteral CatheterEYJ1Contract manufactureraccessdata.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.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
June 24, 2026K260394Hydrophilic coated intermittent nalaton catheter for single use-ready to use (NCR)EZDSubstantially EquivalentHangzhou Jimushi Meditech Co., Ltd.accessdata.fda.gov
April 5, 2023K222677Intermittent nelaton catheter for single useEZDSubstantially EquivalentHangzhou Jimushi Meditech Co., Ltd.accessdata.fda.gov
June 1, 2020K200134Jimushi Sterile Urethral Catheter for single useGBMSubstantially EquivalentHangzhou Jimushi Meditech Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated June 24, 2026. 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.