Data / Medical devices / South Korea / Cimilre Co., Ltd.
Cimilre Co., Ltd.: FDA-registered device maker in Cheonan-si Chungnam, South Korea, 3 510(k) clearances
Cimilre Co., Ltd. is registered with the FDA (registration 3013561139) in Cheonan-si Chungnam, South Korea. It lists 3 device types. The FDA files 3 510(k) clearances under its listings, the newest dated August 21, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013561139
- Address
- 97-14, Seongnam-ro, Mokcheon-eup, Dongnam-gu, Cheonan-si Chungnam, South Korea, 31234
- Owner or operator
- CIMILRE CO.,LTD (10054474)
- Roles
- Manufacturer
- First device listed
- March 22, 2017
- Registered through
- 2026
- Brand names listed
- 24mm Double Pumping Kit, 28mm Double Pumping Kit, AMEDA MYA, AMEDA MYA PRO, CIMILRE Dual Max, CIMILRE F1, CIMILRE P1, CIMILRE S3 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Breast Pump Kit | OHH | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Breast, Non-Powered | HGY | 1 | Manufacturer | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 21, 2026 | K260643 | Cimilre Dual Max | HGX | Substantially Equivalent | Cimilre Co., Ltd. | accessdata.fda.gov |
| December 23, 2022 | K221708 | CIMILRE Free-T2 Plus | HGX | Substantially Equivalent | Cimilre Co., Ltd. | accessdata.fda.gov |
| March 7, 2017 | K162870 | CIMLRE F1 and CIMILRE S3 | HGX | Substantially Equivalent | Cimilre Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Breast Pump Kit
- All makers of Pump, Breast, Powered
- All makers of Pump, Breast, Non-Powered
Updated August 21, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.