Cimilre Dual Max
Device Facts
| Record ID | K260643 |
|---|---|
| Device Name | Cimilre Dual Max |
| Applicant | Cimilre Co., Ltd. |
| Product Code | HGX · Obstetrics/Gynecology |
| Decision Date | Aug 21, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.5160 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A powered breast pump in an electrically powered suction device used to express milk from the breast.