Guangzhou Ekai Electronic Technology Co., Ltd. FDA Record
- No warning letters matched by name
Guangzhou Ekai Electronic Technology Co., Ltd. has 0 FDA recalls, 0 inspections, 1 510(k) clearance and 0 compliance actions on record. No FDA warning letter addressed to "Guangzhou Ekai Electronic Technology Co., Ltd." is on file.
- Latest 510(k)
- Aug 11, 2023
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 1 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 0 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K230420 | Dr. pen Microneedling System | Aug 11, 2023 |
Guangzhou Ekai Electronic Technology Co., Ltd. and the FDA: common questions
Has Guangzhou Ekai Electronic Technology Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Guangzhou Ekai Electronic Technology Co., Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Guangzhou Ekai Electronic Technology Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Guangzhou Ekai Electronic Technology Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
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