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Data / Medical devices / China / Changzhou Holymed Products Co., Ltd

Changzhou Holymed Products Co., Ltd: FDA-registered device maker in CHANGZHOU Jiangsu, China, 3 510(k) clearances

Changzhou Holymed Products Co., Ltd is registered with the FDA (registration 3006891803) in CHANGZHOU Jiangsu, China. It lists 16 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 7, 2021. Registered through 2026. FDA data exported November 2, 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 Changzhou Holymed Products Co., Ltd
FDA registration number
3006891803
Address
525 Changwu Road South Wujin District, CHANGZHOU Jiangsu, China, 213167
Owner or operator
CHANGZHOU HOLYMED PRODUCTS CO., LTD (10024103)
Roles
Contract manufacturer, Manufacturer, Specification developer
First device listed
January 3, 2008
Registered through
2026
Brand names listed
Baby blanket, Barrier Sleeve, Coveralls, Drape, surgical, Gauze / sponge, Infant shirt white, Isolation Mask, Lab Coats, Coveralls and more

Devices it lists

DeviceProduct codeClassRoleSource
Accessory, Surgical ApparelLYU1Contract manufacturer, Manufactureraccessdata.fda.gov
Bag, IceKYR1Contract manufacturer, Manufactureraccessdata.fda.gov
Bedding, Disposable, MedicalKME1Contract manufacturer, Manufactureraccessdata.fda.gov
Brush, Scrub, Operating-RoomGEC1Contract manufacturer, Manufactureraccessdata.fda.gov
Cap, SurgicalFYF1Contract manufacturer, Manufactureraccessdata.fda.gov
Cover, Shoe, Operating-RoomFXP1Contract manufacturer, Manufactureraccessdata.fda.gov
Drape, Surgical, AntimicrobialKKX2Contract manufacturer, Manufactureraccessdata.fda.gov
Drape, Surgical, ExemptPUI2Contract manufacturer, Manufactureraccessdata.fda.gov
Gauze / Sponge,Nonresorbable For External UseNAB1Contract manufacturer, Manufactureraccessdata.fda.gov
General Surgery TrayLRO2Contract manufactureraccessdata.fda.gov
Gown, ExaminationFME1Contract manufacturer, Manufactureraccessdata.fda.gov
Gown, SurgicalFYA2Contract manufacturer, Manufacturer, Specification developeraccessdata.fda.gov
Mask, Gas, AnestheticBSJ1Contract manufacturer, Manufactureraccessdata.fda.gov
Mask, SurgicalFXX2Manufactureraccessdata.fda.gov
Non-Surgical GownOEA1Contract manufacturer, Manufactureraccessdata.fda.gov
Shoe And Shoe Cover, ConductiveBWP1Contract manufacturer, 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
July 7, 2021K210524Surgical MaskFXXSubstantially EquivalentChangzhou Holymed Products Co., Ltd.accessdata.fda.gov
December 20, 2012K121998HM SURGICAL GOWN, NON REINFORCED HM SURGICAL GOWN, FABRIC REINFORCED HM SURGICAL GOWN, POLYERINFORCEDFYASubstantially EquivalentChangzhou Holymed Products Co., Ltd.accessdata.fda.gov
December 12, 2012K122000HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVERKKXSubstantially EquivalentChangzhou Holymed Products Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated July 7, 2021. 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.