Braxx Biotech Co., Ltd.
TaiwanFDA 510(k) applicant, unverified
- Devices
- 2
What Braxx Biotech Co., Ltd. makes
Braxx Biotech Co., Ltd. manufactures esophageal brachytherapy applicators, including the BRAXX applicator and its variants (Model: BKMI2001, BKMI2002). These devices are designed for internal radiation therapy in esophageal treatments, delivering precise radiation doses to targeted tissue.
The company’s products are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The devices are registered in the FDA’s 510(k) database, reflecting their compliance with U.S. medical device authorisation requirements. The company is based in the United States.
Catalogue
“BRAXX” Esophageal Brachytherapy Applicator Ref K183332
510(k) 510(k)- 510(k) 510(k)
Frequently asked questions
How many devices does Braxx Biotech Co., Ltd. have in the registry?
The registry currently lists 2 devices for Braxx Biotech Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Braxx Biotech Co., Ltd.'s devices?
Among its 2 most recently registered devices, Braxx Biotech Co., Ltd. has devices listed in FDA 510(k) (2 devices).
What risk classes do Braxx Biotech Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Braxx Biotech Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Braxx Biotech Co., Ltd. in the registry?
The most recently registered devices listed for Braxx Biotech Co., Ltd. include “BRAXX” Esophageal Brachytherapy Applicator and “BRAXX” Esophageal Brachytherapy Applicator (Model: BKMI2001, BKMI2002).