Data / Medical devices / China / Rayco Electronic Ltd.
Rayco Electronic Ltd.: FDA-registered device maker in Dong Guan City Guangdong, China, 1 510(k) clearance
Rayco Electronic Ltd. is registered with the FDA (registration 3009312584) in Dong Guan City Guangdong, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated September 14, 2007. 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
- 3009312584
- Address
- Ya Yuan Industial Area, Nan Cheng District, Dong Guan City Guangdong, China, 523083
- Owner or operator
- Rayco Electronic Ltd. (10037853)
- Roles
- Manufacturer
- First device listed
- August 24, 2011
- Registered through
- 2026
- Brand names listed
- EA-100, FC-1000, FC-1200, FC-1500, FC-800, FC-810, FC-900, HC-310 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Devices, Breath Trapping, Alcohol | DJZ | 1 | Manufacturer | accessdata.fda.gov |
| System, Breath Measurement | NRH | 1 | Manufacturer | accessdata.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.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 14, 2007 | K071067 | BACTRACK LCD ALCOHOL DETECTOR | DJZ | Substantially Equivalent | Khn Solutions, LLC | accessdata.fda.gov |
Compare with other makers
Updated September 14, 2007. 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.