Data / Medical devices / China / Guangzhou Ekai Electronic Technology Co.,ltd.
Guangzhou Ekai Electronic Technology Co.,ltd.: FDA-registered device maker in guangzhou Guangdong, China, 1 510(k) clearance
Guangzhou Ekai Electronic Technology Co.,ltd. is registered with the FDA (registration 3013360665) in guangzhou Guangdong, China. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated August 11, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013360665
- Address
- 3/F Building E, No. 81 Zijing Road, Liwan District, guangzhou Guangdong, China, 510385
- Owner or operator
- Guangzhou Ekai Electronic Technology Co.,Ltd. (10057206)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- August 17, 2023
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Microneedle Device | QAI | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| August 11, 2023 | K230420 | Dr. pen Microneedling System | QAI | Substantially Equivalent | Guangzhou Ekai Electronic Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated August 11, 2023. 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.