Bioptik Technology, Inc.
Country not established FDA
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Bioptik Technology, Inc. makes
Bioptik Technology, Inc. manufactures the EASYMATE Blood Glucose Monitoring System, a device designed for measuring blood glucose levels in diabetic patients. This system includes components for sample collection, testing, and result display, intended for home or clinical use.
The company’s portfolio is regulated under Class II devices in the United States, with relevant products authorised via the FDA’s 510(k) pathway. The manufacturer is based in the US.
Catalogue
Easymate Blood Glucose Monitoring System Ref K053312
Regimes: 510(k) Registry: 510(k)
FDA establishments
- Bioptik Technology, Inc. Jhunan Township Miaoli · TW FEI 3005706626
Frequently asked questions
How many devices does Bioptik Technology, Inc. have in the registry?
The registry currently lists 1 device for Bioptik Technology, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Bioptik Technology, Inc.'s devices?
Among its 1 most recently registered device, Bioptik Technology, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Bioptik Technology, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Bioptik Technology, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Bioptik Technology, Inc. in the registry?
The most recently registered devices listed for Bioptik Technology, Inc. include EASYMATE BLOOD GLUCOSE MONITORING SYSTEM.
Which FDA establishments are linked to Bioptik Technology, Inc.?
1 FDA establishment is linked to Bioptik Technology, Inc. in the registry; they are listed on the company page.