Broadmaster Biotech Corporation
TaiwanFDA 510(k) applicant, unverified
- Devices
- 4
What Broadmaster Biotech Corporation makes
Broadmaster Biotech Corporation manufactures the Broadmaster Healthcare System, a medical device designed for clinical or home healthcare applications, and the Glucose Shepherd Blood Glucose Monitoring System, which measures and tracks blood glucose levels for diabetes management.
The company’s portfolio is regulated under FDA’s Class II device classification, with devices authorised via the 510(k) pathway. The manufacturer is based in the United States.
Catalogue
Advocate Non-Contact Infrared Thermometer Ref K180355
510(k) 510(k)Advocate Non-Contact Infrared Thermometer Ref K191004
510(k) 510(k)Broadmaster Healthcare System Ref K130621
510(k) 510(k)Glucose Shepherd Blood Glucose Monitoring System Ref K102316
510(k) 510(k)
Frequently asked questions
How many devices does Broadmaster Biotech Corporation have in the registry?
The registry currently lists 4 devices for Broadmaster Biotech Corporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Broadmaster Biotech Corporation's devices?
Among its 4 most recently registered devices, Broadmaster Biotech Corporation has devices listed in FDA 510(k) (4 devices).
What risk classes do Broadmaster Biotech Corporation's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Broadmaster Biotech Corporation's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Broadmaster Biotech Corporation in the registry?
The most recently registered devices listed for Broadmaster Biotech Corporation include Advocate Non-Contact Infrared Thermometer, BROADMASTER HEALTHCARE SYSTEM and GLUCOSE SHEPHERD BLOOD GLUCOSE MONITORING SYSTEM.