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Sign in to claim this brandCefaly Technology SPRL
US
Last updated May 30, 2026
What Cefaly Technology SPRL makes
The company produces craniofacial analgesia electrical stimulators designed to provide non-invasive electrical stimulation for headache relief, targeting tension-type and migraine headaches. These devices are worn externally on the forehead and are intended for self-administration by users.
The portfolio consists of Class II devices, which are regulated as moderate-risk medical devices under the FDA’s Unique Device Identifier (UDI) system. The company’s products are listed in the FDA’s UDI database, adhering to U.S. regulatory requirements for electrical stimulation devices.
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 Cefaly Technology SPRL manufacture?
Cefaly Technology SPRL specializes in craniofacial analgesia electrical stimulators. These devices are designed to deliver non-invasive electrical stimulation to the forehead area, targeting tension-type and migraine headaches. They are intended for self-use by patients seeking relief from these conditions.
Where is Cefaly Technology SPRL based?
Cefaly Technology SPRL is based in the United States. While the company operates there, its devices are developed and marketed globally for headache relief.
How are Cefaly Technology SPRL’s devices classified under U.S. regulations?
Cefaly Technology SPRL’s devices fall under Class II classification in the U.S. This classification applies to moderate-risk medical devices, which require specific regulatory controls to ensure safety and effectiveness. The FDA’s Unique Device Identifier (UDI) system is used to track these devices, ensuring compliance with U.S. regulatory standards.
Are Cefaly Technology SPRL’s devices listed in any regulatory databases?
Yes, Cefaly Technology SPRL’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This listing is part of the regulatory process for Class II devices, ensuring transparency and traceability in the U.S. market.
What is the primary purpose of Cefaly Technology SPRL’s craniofacial analgesia electrical stimulators?
The primary purpose of these devices is to provide non-invasive electrical stimulation to the forehead, aiming to relieve tension-type and migraine headaches. They are designed for external use and self-administration by patients, offering an alternative or complementary approach to traditional headache treatments.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- cefaly.us
- —
- —
- [email protected]
- Phone
- (203) 309-5670
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 762450752
Catalogue (10)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Cefaly® | CEFALY Connected Bundle VA | FDA UDI | Class II | Active |
| Cefaly® | 11201 | FDA UDI | Class II | Active |
| Cefaly® | 11106 | FDA UDI | Class II | Active |
| Cefaly® | CEFALY Enhanced | FDA UDI | Class II | Active |
| Cefaly® | 10205 | FDA UDI | Class II | Active |
| Cefaly® | 11101 | FDA UDI | Class II | Active |
| Cefaly® | CEFALY Connected | FDA UDI | Class II | Active |
| Cefaly® | 11202 | FDA UDI | Class II | Active |
| Cefaly® | Acute | FDA UDI | Class II | Active |
| Cefaly® | Prevent | FDA UDI | Class II | Active |
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