Cimilre Dual Max
510(k) K260643
Cimilre Dual Max is a Class II device made by Cimilre Co ., Ltd, cleared under FDA 510(k) K260643 on 21 Aug 2026, active as of 8 Nov 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK260643 | Date21 Aug 2026 | StatusActive |
Official records
- FDA 510(k) database K260643
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- HGX
- FDA applicant
- Cimilre Co., Ltd.
- Device class
- Class II
- Regulation
- 21 CFR Part 884.5160
- Advisory committee
- Obstetrics/Gynecology
- FDA decision
- SESE Substantially Equivalent
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