Skip to the page

Data / Medical devices / China / Vcomin Technology Limited

Vcomin Technology Limited: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance

Vcomin Technology Limited is registered with the FDA (registration 3017195985) in Shenzhen Guangdong, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated May 29, 2019. 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.

FDA registration number
3017195985
Address
2&3 FI., No.1, Kangzheng Rd., Buji Town, Shenzhen Guangdong, China, 518110
Owner or operator
Vcomin Technology Limited (10074485)
Roles
Manufacturer
First device listed
May 25, 2020
Registered through
2026
Brand names listed
Fetal Doppler, model FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, FD-591D, Fetal Doppler, model FD-260B, FD-260G, FD-290B, FD-290G, FD-570B, FD-570G, Fetal Doppler, model FD-500B, FD-500G, FD-510B, FD-510G, FD-590B, FD-590G, FD-610B, FD-610G, Fetal Doppler, model FD-530B, FD-530G, FD-640G, Fetal Doppler, model FD-540B, FD-540G, FD-540C, FD-540D

Devices it lists

DeviceProduct codeClassRoleSource
Monitor, Ultrasonic, FetalKNG2Manufactureraccessdata.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
May 29, 2019K182526Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D)KNGSubstantially EquivalentVcomin Technology Limitedaccessdata.fda.gov

Compare with other makers

Updated May 29, 2019. 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.