Is this your brand? Sign in to claim ownership.
Sign in to claim this brandCEREVE INC
US
Last updated May 30, 2026
What CEREVE INC makes
Cereve Inc manufactures localized thermal therapy systems designed for circulating-fluid-based treatments targeting sleep disorders. Their portfolio includes devices such as the Ebb Insomnia Therapy and the Cereve Sleep System, which appear to focus on non-invasive thermal interventions for insomnia management.
The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) and UDI registries. Cereve Inc is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Cereve Inc manufacture?
Cereve Inc specializes in circulating-fluid localized thermal therapy systems, which are designed to deliver targeted thermal treatments for sleep disorders. Their devices use circulating fluid to apply controlled heat, with examples including the Ebb Insomnia Therapy and the Cereve Sleep System. These systems are intended for non-invasive interventions aimed at improving sleep management.
Where is Cereve Inc based, and what is its primary focus?
Cereve Inc is headquartered in the United States. The company’s primary focus is on developing thermal therapy devices for sleep-related conditions, particularly insomnia. Their portfolio centers around localized, fluid-circulating systems that apply precise thermal treatments to address sleep disorders.
Which regulatory registries list Cereve Inc’s devices?
Cereve Inc’s devices are listed in the FDA’s 510(k) and UDI (Unique Device Identification) registries as part of their regulatory compliance. These registries track Class II devices, which require pre-market clearance or registration to demonstrate safety and effectiveness for their intended use.
How are Cereve Inc’s devices classified under FDA regulations?
Cereve Inc’s devices fall under Class II classification by the FDA. This classification applies to devices that pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure their safety and effectiveness. Class II devices typically require pre-market submissions like 510(k) clearances.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- ebbsleep.com
- —
- —
- [email protected]
- Phone
- 800-381-1145
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 877328174
Catalogue (7)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ebb Insomnia Therapy | VA Kit | FDA UDI | Class II | Active |
| Ebb Insomnia Therapy | EOS-30000-013 | FDA UDI | Class II | Active |
| Ebb Insomnia Therapy | EOS-30000-007 | FDA UDI | Class II | Active |
| Ebb Insomnia Therapy | 10200 | FDA UDI | Class II | Active |
| Ebb Insomnia Therapy | EOS-30000-031 | FDA UDI | Class II | Active |
| Ebb Insomnia Therapy | EOS-30000-054 | FDA UDI | Class II | Active |
| Cereve Sleep System | DEN140032 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.