Medmix Co., Ltd.
Country not established FDA
- Devices
- 3
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Medmix Co., Ltd. makes
Medmix Co., Ltd. manufactures the Smartlux Mini and SMARTLUX, which appear to be Class II medical devices designed for diagnostic or monitoring purposes, likely involving advanced imaging or optical technology for clinical use.
These devices are regulated under the FDA’s 510(k) pathway as Class II products and are listed in the U.S. Food and Drug Administration’s 510(k) database. The company is based in the United States.
Catalogue
- Regimes: CE MDD Registry: EUDAMEDGUDID
Smartlux Mini Ref K221083
Regimes: 510(k) Registry: 510(k)Smartlux Ref K120460
Regimes: 510(k) Registry: 510(k)
Company details
- DUNS number
- 557812813
FDA establishments
- Medmix Co., Ltd Yeonsu-gu Incheon · KR FEI 3023344923
Frequently asked questions
How many devices does Medmix Co., Ltd. have in the registry?
The registry currently lists 3 devices for Medmix Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medmix Co., Ltd.'s devices?
Among its 3 most recently registered devices, Medmix Co., Ltd. has devices listed in EUDAMED (1 device), FDA 510(k) (2 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Medmix Co., Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Medmix Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Medmix Co., Ltd. in the registry?
The most recently registered devices listed for Medmix Co., Ltd. include SMARTLUX MINI D478000, Smartlux Mini and SMARTLUX.
Which FDA establishments are linked to Medmix Co., Ltd.?
1 FDA establishment is linked to Medmix Co., Ltd. in the registry; they are listed on the company page.