Data / Medical devices / South Korea / Miracell Co.,Ltd.
Miracell Co.,Ltd.: FDA-registered device maker in Seongnam-si Gyeonggi, South Korea, 2 510(k) clearances
Miracell Co.,Ltd. is registered with the FDA (registration 3023346439) in Seongnam-si Gyeonggi, South Korea. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 2, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023346439
- Address
- B-502~504 & 601~608, 215, Galmachi-ro, Jungwon-gu, Seongnam-si Gyeonggi, South Korea, 13217
- Owner or operator
- Miracell Co.,Ltd. (10085629)
- Roles
- Manufacturer
- First device listed
- July 12, 2022
- Registered through
- 2026
- Brand names listed
- CHROMA M-CELL, SMART M-CELL Bone Marrow Concentration System, SMART M-CELL PRP Concentration System_BSC+3 240, SMART M-CELL PRP Concentration System_BSC+3 30, BSC+3 60, BSC+3 120, Smart M-Cell 2, Smart M-Cell 4
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Arthroscopic | NBH | 1 | Manufacturer | accessdata.fda.gov |
| Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate | QBV | 1 | Manufacturer | accessdata.fda.gov |
| Centrifuge, Blood-Bank For In Vitro Diagnostic Use | KSO | 1 | Manufacturer | accessdata.fda.gov |
| Stand, Infusion | FOX | 1 | 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 |
|---|---|---|---|---|---|---|
| April 2, 2026 | K250518 | SMART M-CELL Bone Marrow Concentration System | QBV | Substantially Equivalent | Miracell Co., Ltd. | accessdata.fda.gov |
| April 2, 2026 | K250516 | SMART M-CELL PRP Concentration System | QBV | Substantially Equivalent | Miracell Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Centrifuge For Preparation Of Cell Concentrate And/Or Plasma Concentrate
- All makers of Centrifuge, Blood-Bank For In Vitro Diagnostic Use
- All makers of Stand, Infusion
- All makers of Accessories, Arthroscopic
Updated April 2, 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.