Philosys, Inc.
United StatesFDA applicant, unverified
Philosys, Inc. is a medical device manufacturer, with 42 devices listed in FDA GUDID and FDA 510(k) (FDA Class II and I) as of 13 Nov 2026.
- Devices
- 42
Registry facts
- Registries
- FDA GUDID 37
- FDA 510(k) 5
- Device classes
- FDA Class II 33
- FDA Class I 9
What Philosys, Inc. makes
Philosys, Inc. manufactures in vitro diagnostic (IVD) blood glucose monitoring systems designed for home use. These include strip-based meters, control solutions for calibration, and systems with voice feedback or smart connectivity features, such as the Gmate® and GlucoTrack series.
The company’s devices are regulated under FDA pathways, including 510(k) clearances and de novo submissions, with products classified as Class I or Class II.
Catalogue
Search and filter all 42 devicesFrequently asked questions
How many devices does Philosys, Inc. have in the registry?
The registry currently lists 42 devices for Philosys, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Philosys, Inc.'s devices?
Among its 42 most recently registered devices, Philosys, Inc. has devices listed in FDA 510(k) (5 devices) and FDA GUDID (37 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Philosys, Inc.'s devices fall under?
Among its 42 most recently registered devices, the classes recorded for Philosys, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Philosys, Inc. in the registry?
The most recently registered devices listed for Philosys, Inc. include Gmate® Control Solution Level 3 PC-003, Gmate® Origin Blood Glucose Monitoring System PG-310, Gmate® SMART Blood Glucose Monitoring System PG-101 and Gmate® VOICE Blood Glucose Monitoring System PG-301.