Jiangsu Enjosim Medical Technology Co., Ltd. FDA Record
Jiangsu Enjosim Medical 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 "Jiangsu Enjosim Medical Technology Co., Ltd." is on file.
- Latest 510(k)
- Aug 14, 2026
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 1 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 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 |
|---|---|---|
| K253747 | Disposable Pen Injector (KXYC-03C02, KXYC-03A03) | Aug 14, 2026 |
Jiangsu Enjosim Medical Technology Co., Ltd. and the FDA: common questions
Has Jiangsu Enjosim Medical Technology Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Jiangsu Enjosim Medical 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 Jiangsu Enjosim Medical Technology Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Jiangsu Enjosim Medical Technology Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
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