Bts SpA
Country not established
Bts SpA is a medical device manufacturer, with 13 devices listed in FDA GUDID and EUDAMED (FDA Class II and I) as of 13 Nov 2026.
- Devices
- 13
Registry facts
- Registries
- FDA GUDID 13
- EUDAMED 3
- Device classes
- FDA Class II 12
- FDA Class I 1
- Identifiers
- DUNS 428484518
What Bts SpA makes
BTS SPA develops biomechanical analysis systems focused on motion-tracking and gait assessment, including devices like TMJOINT and P6000. Their portfolio also includes electromyography solutions such as FREEEMG, OMNisEMG, and TEETHAN, which measure muscle activity and jaw movement. The company produces wearable and modular systems like SMART and baiobit for clinical and research applications.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. BTS SPA operates from the United States, adhering to regulatory requirements for medical devices in that jurisdiction.
Catalogue
Search and filter all 13 devicesCompany details
- DUNS number
- 428484518
Frequently asked questions
How many devices does BTS SPA have in the registry?
The registry currently lists 13 devices for BTS SPA. Devices recorded under merged duplicate company entries are counted once.
Which registries list BTS SPA's devices?
Among its 13 most recently registered devices, BTS SPA has devices listed in EUDAMED (3 devices) and FDA GUDID (13 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do BTS SPA's devices fall under?
Among its 13 most recently registered devices, the classes recorded for BTS SPA's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from BTS SPA in the registry?
The most recently registered devices listed for BTS SPA include SMART DX EVO HYBRID, TMJOINT 1.0, SMART DX EVO2 and P6000.