MC10, Inc.
Country not established
- Devices
- 29
What MC10, Inc. makes
MC10, Inc. develops wearable, wireless biosensors designed for continuous physiological monitoring, including the BioStamp nPoint system. This device captures multi-modal data such as ECG, respiration, temperature, and activity metrics, enabling real-time health tracking and research applications. It is engineered for long-term adherence and integrates with mobile and cloud platforms for data analysis.
The company’s products fall under FDA Class II regulatory classification and are authorised via the 510(k) pathway. The BioStamp nPoint is listed in the FDA’s 510(k) database, adhering to US medical device regulations. The manufacturer operates from the United States.
Catalogue
Search and filter all 29 devicesCompany details
- DUNS number
- 829221139
- [email protected]
- Phone
- 8572145630
Frequently asked questions
How many devices does MC10, INC. have in the registry?
The registry currently lists 29 devices for MC10, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list MC10, INC.'s devices?
Among its 29 most recently registered devices, MC10, INC. has devices listed in FDA 510(k) (1 device) and FDA GUDID (28 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do MC10, INC.'s devices fall under?
Among its 29 most recently registered devices, the classes recorded for MC10, INC.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from MC10, INC. in the registry?
The most recently registered devices listed for MC10, INC. include BioStamp nPoint™ SW-0025, BioStamp® BRCA02, Kintinuum™ MC-0016 and BioStamp nPoint™ MC-0004.