Cellumed Co., Ltd.
South KoreaFDA applicant, unverified
- Devices
- 1
What Cellumed Co., Ltd. makes
Cellumed Co., Ltd. manufactures the Rafugen DBM, a demineralized bone matrix product designed for bone grafting and tissue regeneration in orthopedic and maxillofacial surgical applications.
The Rafugen DBM is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Rafugen DBM Ref K180121
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cellumed Co., Ltd. have in the registry?
The registry currently lists 1 device for Cellumed Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cellumed Co., Ltd.'s devices?
Among its 1 most recently registered device, Cellumed Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Cellumed Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Cellumed Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cellumed Co., Ltd. in the registry?
The most recently registered devices listed for Cellumed Co., Ltd. include Rafugen DBM.