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Data / Medical devices / China / Hangzhou Jincheng Medical Supplies Manufacture Co., Ltd.

Hangzhou Jincheng Medical Supplies Manufacture Co., Ltd.: FDA-registered device maker in Hangzhou Zhejiang, China, 3 510(k) clearances

Hangzhou Jincheng Medical Supplies Manufacture Co., Ltd. is registered with the FDA (registration 3003561450) in Hangzhou Zhejiang, China. It lists 15 device types. The FDA files 3 510(k) clearances under its listings, the newest dated October 21, 2022. Registered through 2026. FDA data exported November 3, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this oneWatch Hangzhou Jincheng Medical Supplies Manufacture Co., Ltd.
FDA registration number
3003561450
Address
No. 202, Zhangshan Road, Renhe Town, Yuhang District, Hangzhou Zhejiang, China, 311107
Owner or operator
MEDTECS (CAMBODIA) CORP. LIMITED (10074525)
Roles
Contract manufacturer, Exporter to the US, Manufacturer, Specification developer
First device listed
May 26, 2020
Registered through
2026
Brand names listed
AMD-Ritmed AssureWear Versagown, ASTM PB70 Level 4 Isolation Gown, Bandage, Bouffant Cap, Chemo Gown, Conductive Shoe and Shoe Cover, Coverall with tape, Cuff Barrier Sleeve and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Exporter to the US, Manufactureraccessdata.fda.gov
Bag, Urine Collection, Leg, For External Use, SterileFAQ1Contract manufactureraccessdata.fda.gov
Bandage, ElasticFQM1Exporter to the USaccessdata.fda.gov
Cap, SurgicalFYF1Contract manufactureraccessdata.fda.gov
Dress, SurgicalFYE1Exporter to the USaccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Manufactureraccessdata.fda.gov
Garment, Protective, For IncontinenceEYQ1Contract manufacturer, Exporter to the US, Manufactureraccessdata.fda.gov
Gown, ExaminationFME1Exporter to the USaccessdata.fda.gov
Gown, Isolation, SurgicalFYC2Exporter to the US, Manufactureraccessdata.fda.gov
Gown, SurgicalFYA2Exporter to the US, Manufactureraccessdata.fda.gov
Injector And Syringe, AngiographicDXT2Contract manufactureraccessdata.fda.gov
Medical Gowns With Chemotherapy Labeling Claims - Tested For Use With Chemotherapy DrugsQSO2Exporter to the US, Manufactureraccessdata.fda.gov
Non-Surgical GownOEA1Exporter to the US, Manufactureraccessdata.fda.gov
Shoe And Shoe Cover, ConductiveBWP1Specification developeraccessdata.fda.gov
System, Urine Drainage, Closed, For Non-Indwelling Catheter, Non-SterileNNZ1Contract 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
October 21, 2022K210414CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo GownFYCSubstantially EquivalentMedtecs (Taiwan) Corp.accessdata.fda.gov
January 17, 2020K190306AMD Ritmed AssureWear VersaGownFYCSubstantially EquivalentAmd Medicom, Inc.accessdata.fda.gov
March 11, 2011K102692SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR, REGULAR WITH GUIDER), SPUNLACE GOWNS (REINFOFYASubstantially EquivalentHangzhou Jincheng Medical Supplier Manufacture Co.accessdata.fda.gov

Compare with other makers

Updated October 21, 2022. 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.