Bestgen Biotech Corp.
TaiwanFDA applicant, unverified
- Devices
- 6
What Bestgen Biotech Corp. makes
Bestgen Biotech Corp. manufactures blood glucose monitoring systems, including standalone meters and integrated solutions for glucose control. Their portfolio includes models such as the AP-1000, AP-1010, AP-1020, AP-2000 series, AP-3000, and the Major III, designed for continuous or periodic glucose level tracking.
These devices are classified as Class II under FDA regulations and are recorded in the FDA’s 510(k) premarket notification database. The company is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Major Iii Blood Glucose Monitoring System Ref K072274
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
- Regimes: 510(k) Registry: 510(k)
Ap-1000 Blood Glucose Monitoring System Ref K090389
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Bestgen Biotech Corp. have in the registry?
The registry currently lists 6 devices for Bestgen Biotech Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bestgen Biotech Corp.'s devices?
Among its 6 most recently registered devices, Bestgen Biotech Corp. has devices listed in FDA 510(k) (6 devices).
What risk classes do Bestgen Biotech Corp.'s devices fall under?
Among its 6 most recently registered devices, the classes recorded for Bestgen Biotech Corp.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bestgen Biotech Corp. in the registry?
The most recently registered devices listed for Bestgen Biotech Corp. include AP-1010 AND AP-1020 BLOOD GLUCOSE MONITORING SYSTEM, MAJOR GLUCOSE CONTROL SOLUTION, MAJOR III BLOOD GLUCOSE MONITORING SYSTEM, AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM and AP-1000 BLOOD GLUCOSE MONITORING SYSTEM, MODEL AP-1000, MAJOR GLUCOSE CONTROL SOLUTION.