Data / Medical devices / China / Shenzhen Kaiyan Medical Equipment Co., Ltd

Shenzhen Kaiyan Medical Equipment Co., Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 27 510(k) clearances

Shenzhen Kaiyan Medical Equipment Co., Ltd is registered with the FDA (registration 3011644607) in Shenzhen Guangdong, China. It lists 17 device types. The FDA files 27 510(k) clearances under its listings, the newest dated July 23, 2026. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number

3011644607

Address

Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town BaoAn District, Shenzhen Guangdong, China, 518103

Owner or operator

Shenzhen Kaiyan Medical Equipment Co., Ltd (10049428)

Roles

Contract manufacturer, Exporter to the US, Manufacturer

First device listed

June 1, 2015

Registered through

2027

Brand names listed

AMIRO LED LIGHT EYE MASK (Model: ABYM02), AXRAH Full-Body Red Light Therapy Mat (Model: FLUX, PULSE, ARC), Aduro Blue Facial Mask, Aduro Eye Mask (EY-20AC), Aduro Facial Mask, Aduro LED Neck Mask, Aduro Neck Mask, Aduro Plam and more

Devices it lists

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.

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Updated July 23, 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.