Miracell Co., Ltd.
South KoreaFDA applicant, unverified FDA
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Miracell Co., Ltd. makes
Miracell Co., Ltd. manufactures the SMART M-CELL Bone Marrow Concentration System and the SMART M-CELL PRP Concentration System, which are designed to concentrate bone marrow aspirate and platelet-rich plasma for regenerative applications.
These devices are classified as Class I under FDA regulations and are listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
SMART M-CELL Bone Marrow Concentration System Ref K250518
Regimes: 510(k) Registry: 510(k)SMART M-CELL PRP Concentration System Ref K250516
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Miracell Co., Ltd. Seongnam-si Gyeonggi · KR FEI 3023346439
Frequently asked questions
How many devices does Miracell Co., Ltd. have in the registry?
The registry currently lists 2 devices for Miracell Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Miracell Co., Ltd.'s devices?
Among its 2 most recently registered devices, Miracell Co., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Miracell Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Miracell Co., Ltd.'s devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Miracell Co., Ltd. in the registry?
The most recently registered devices listed for Miracell Co., Ltd. include SMART M-CELL Bone Marrow Concentration System and SMART M-CELL PRP Concentration System.
Which FDA establishments are linked to Miracell Co., Ltd.?
1 FDA establishment is linked to Miracell Co., Ltd. in the registry; they are listed on the company page.