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Data / Medical devices / China / Cofoe Medical Technology Co.,ltd

Cofoe Medical Technology Co.,ltd: FDA-registered device maker in Changsha Hunan, China, 1 510(k) clearance

Cofoe Medical Technology Co.,ltd is registered with the FDA (registration 3016426850) in Changsha Hunan, China. It lists 22 device types. The FDA files 1 510(k) clearance under its listings, the newest dated January 4, 2024. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Cofoe Medical Technology Co.,ltd
FDA registration number
3016426850
Address
No. 87, Section 1 of Huanbao East Road, Yuhua District, 410000 Changsha, Hunan, CHINA, Changsha Hunan, China, 410000
Owner or operator
COFOE MEDICAL TECHNOLOGY CO.,LTD (10061943)
Roles
Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
First device listed
May 10, 2021
Registered through
2026
Brand names listed
Adhesive Remover, Adhesive stripper rub, Adult Diapers (Garment, Protective, For Incontinence), Air Mattress, Air Mattress with Compressor, Alternating Pressure Pump & Bubble Mattress, Ankle Brace, Anti-decubitus Mattress and more

Devices it lists

DeviceProduct codeClassRoleSource
Adaptor, HygieneILS1Repackager or relabeleraccessdata.fda.gov
Apparatus, Suction, Operating-Room, Wall Vacuum PoweredGCX2Contract manufacturer, Manufactureraccessdata.fda.gov
Cement, Stomal Appliance, OstomyEZR1Manufactureraccessdata.fda.gov
Clinical Electronic ThermometerSDV2Manufactureraccessdata.fda.gov
CrutchIPR1Manufactureraccessdata.fda.gov
Dressing, Wound, HydrophilicNAC1Contract manufacturer, Manufactureraccessdata.fda.gov
Garment, Protective, For IncontinenceEYQ1Manufactureraccessdata.fda.gov
Hearing Aid, Air-Conduction, Over The CounterQUF1Manufactureraccessdata.fda.gov
Irrigator, OstomyEXD2Manufactureraccessdata.fda.gov
Lamp, Infrared, Therapeutic HeatingILY2Exporter to the US, Manufactureraccessdata.fda.gov
Mattress, Air Flotation, Alternating PressureFNM2Contract manufactureraccessdata.fda.gov
Orthosis, CervicalIQK1Repackager or relabeleraccessdata.fda.gov
Orthosis, LumbarIQE1Repackager or relabeleraccessdata.fda.gov
Orthosis, ThoracicIPT1Repackager or relabeleraccessdata.fda.gov
OximeterDQA2Manufactureraccessdata.fda.gov
Pouch, ColostomyEZQ1Manufactureraccessdata.fda.gov
Protector, OstomyEXE1Manufactureraccessdata.fda.gov
Regulator, Pressure, Gas CylinderCAN1Contract manufacturer, Manufactureraccessdata.fda.gov
Solvent, Adhesive TapeKOX1Manufactureraccessdata.fda.gov
Splint, Hand, And ComponentsILH1Repackager or relabeleraccessdata.fda.gov
Stocking, Medical Support (To Prevent Pooling Of Blood In Legs)DWL2Contract manufacturer, Manufactureraccessdata.fda.gov
Walker, MechanicalITJ1Repackager or relabeleraccessdata.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
January 4, 2024K230277Pulse Oximeter(Model OHT60,OXH78)DQASubstantially EquivalentCofoe Medical Technology Co., Ltd.accessdata.fda.gov

Compare with other makers

Updated January 4, 2024. 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.