Guangzhou Ekai Electronic Technology Co., Ltd.
Manufacturer and brand owner in Guangzhou, Guangdong, China. 1 device type, 1 product catalogued, 1 clearance.
Guangzhou Ekai Electronic Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Powered Microneedle Device. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2023.
1device type
1product
1510(k) clearance
Registration
| Registered name | GUANGZHOU EKAI ELECTRONIC TECHNOLOGY CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013360665 |
| FEI number | 3013360665 |
| DUNS | 551479834 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 廣州意凱電子科技有限公司 |
|---|---|
| Source | Hong Kong company register lookup |
Location
| City | Guangzhou |
|---|---|
| Province | Guangdong |
| Address | 3/F Building E, No. 81 Zijing Road, Liwan District |
| Postal code | 510385 |
| Country | China |
What It Makes
| Device type | Class | Listed since | Chinese makers |
|---|---|---|---|
| Powered Microneedle Device | Class 2 | 2023 | 10 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Dr.Pen | QAI | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K230420 | 2023-08-11 | QAI | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2008 |
|---|---|
| Factory area | 14000 |
| Main products | Dr Pen M9 microneedle pen, Dr Pen H6 microneedling pen, Bio Pen 6 microneedling pen, Derma rollers, Permanent makeup devices |
| Certifications | ISO 13485, ISO 13458/MDSAP, FDA 510(k) clearance, China medical device production license |
| Export markets | United States, Europe |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.