Hwajin Medical Co., Ltd.
South KoreaFDA applicant, unverified
- Devices
- 1
What Hwajin Medical Co., Ltd. makes
Hwajin Medical Co., Ltd. manufactures the Sofjec, a medical device designed for [specific clinical purpose not detailed in data]. The product is intended for [application context, e.g., diagnostic, therapeutic, or monitoring use] within [relevant anatomical or procedural area, e.g., cardiovascular, orthopedic, or imaging].
The Sofjec is classified as a Class II device under FDA regulations and is listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Sofjec Ref K212635
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Hwajin Medical Co., Ltd. have in the registry?
The registry currently lists 1 device for Hwajin Medical Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hwajin Medical Co., Ltd.'s devices?
Among its 1 most recently registered device, Hwajin Medical Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Hwajin Medical Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Hwajin Medical Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hwajin Medical Co., Ltd. in the registry?
The most recently registered devices listed for Hwajin Medical Co., Ltd. include Sofjec.