Daeshin Enterprise Co., Ltd.
South KoreaFDA 510(k) applicant, unverified
- Devices
- 1
What Daeshin Enterprise Co., Ltd. makes
Daeshin Enterprise Co., Ltd. manufactures the Azure device, a Class II medical product intended for specific clinical applications.
The Azure device is regulated under the FDA’s 510(k) pathway and is listed in the U.S. regulatory database. The company is based in the United States.
Catalogue
Azure Ref K231514
510(k) 510(k)
Frequently asked questions
How many devices does Daeshin Enterprise Co., Ltd. have in the registry?
The registry currently lists 1 device for Daeshin Enterprise Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Daeshin Enterprise Co., Ltd.'s devices?
Among its 1 most recently registered device, Daeshin Enterprise Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Daeshin Enterprise Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Daeshin Enterprise Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Daeshin Enterprise Co., Ltd. in the registry?
The most recently registered devices listed for Daeshin Enterprise Co., Ltd. include Azure.