Biolinq Incorporated
Country not established FDA establishment FEI 3025798257
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
What Biolinq Incorporated makes
Biolinq Incorporated manufactures the Biolinq Shine, an autonomous microsensor designed to measure time-in-range for continuous glucose monitoring, providing real-time glucose data for diabetes management.
The Biolinq Shine is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
- 510(k) 510(k)
Biolinq Shine Autonomous Time-in-Range Microsensor Ref DEN240080
De Novo 510(k)
Company details
- FDA FEI number
- 3025798257
- Address
- 10260 Sorrento Valley Rd, San Diego, CA, 92121
Frequently asked questions
How many devices does BIOLINQ INCORPORATED have in the registry?
The registry currently lists 2 devices for BIOLINQ INCORPORATED. Devices recorded under merged duplicate company entries are counted once.
Which registries list BIOLINQ INCORPORATED's devices?
Among its 2 most recently registered devices, BIOLINQ INCORPORATED has devices listed in FDA 510(k) (2 devices).
What risk classes do BIOLINQ INCORPORATED's devices fall under?
Among its 2 most recently registered devices, the classes recorded for BIOLINQ INCORPORATED's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from BIOLINQ INCORPORATED in the registry?
The most recently registered devices listed for BIOLINQ INCORPORATED include Biolinq Shine Autonomous Time-in-Range Microsensor.