Neurotronics, LLC
Active in EUDAMEDUnited Statesfrom SRN EUDAMED FDA SRN US-MF-000030839 FEI 3002459124
Neurotronics, LLC is a medical device manufacturer based in the United States, with 72 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (EU Class I and IIa; FDA Class II and I) as of 13 Nov 2026.
- Devices
- 72
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA GUDID 61
- EUDAMED 38
- FDA 510(k) 11
- Device classes
- EU Class I 34
- FDA Class II 33
- EU Class IIa 4
- FDA Class I 1
- Top EMDN categories
- Sites and related companies
- NIHON KOHDEN EUROPE GmbH authorised representative
- Identifiers
- EUDAMED SRN US-MF-000030839
- FDA FEI 3002459124
- DUNS 036405363
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
- Authorised rep.
- NIHON KOHDEN EUROPE GmbHDE
What Neurotronics, LLC makes
Neurotronics, LLC manufactures home-use sleep apnoea recording systems, sleep disorder interpretive software for professional use, bioelectrical signal analysis software, and polysomnographs. Example devices include the NomadAir PMU810 Portable Recorder, RIP belts in various sizes, USB DC Box, and software such as Polysmith and Live View Panel versions.
The company's devices are classified as Class I, Class II, and Class IIa and are listed in the Eudamed, FDA 510(k), and FDA UDI databases. Neurotronics, LLC is based in the United States.
Catalogue
Search and filter all 72 devicesShowing 1-50 of 72
Company details
- EUDAMED SRN
- US-MF-000030839
- FDA FEI number
- 3002459124
- DUNS number
- 036405363
- EUDAMED status
- Active
- EUDAMED registered name
- Neurotronics, LLC
- EUDAMED abbreviated name
- Neurotronics
- Registered address
- 13800, Tech City Circle, Suite 400, 32615, Alachua, United States
- Website
- www.neurotronics.com
- Phone
- +1 (352) 372-9955
- PRRC contact
- James Smith
Frequently asked questions
How many devices does Neurotronics, LLC have in the registry?
The registry currently lists 72 devices for Neurotronics, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Neurotronics, LLC's devices?
Among its 50 most recently registered devices, Neurotronics, LLC has devices listed in EUDAMED (16 devices), FDA 510(k) (11 devices) and FDA GUDID (39 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Neurotronics, LLC's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Neurotronics, LLC's devices are Class I, Class IIa and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Neurotronics, LLC in the registry?
The most recently registered devices listed for Neurotronics, LLC include NiteLynx PVDF Effort Sensor Disposable Belt, Pre-Cut, NiteLynx PVDF Effort Sensor 1.5mm DIN, 0.6m, NiteLynx PVDF Effort Sensor 1.5mm DIN, 2.0m and NiteLynx PVDF Effort Sensor 249 Keyhole, 2.0m.