FDA Registration
Active
🇧🇪 Belgium
CEFALY TECHNOLOGY
Reg #: 3010188009
·
FEI: 3010188009
·
Expires 2026
Products
1
Proprietary Names
9
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- CEFALY TECHNOLOGY
- Registration Number
- 3010188009
- FEI Number
- 3010188009
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Boulevard Patience et Beaujonc 3, bte 28
- City
- Liege
- Country
- BE
Regulatory Submissions
- 510(k) Number
- K201895
Owner / Operator
- Firm Name
- CEFALY Technology
- Operator Number
- 10046449
- Address
- Boulevard Patience et Beaujonc 3, bte 28
- City
- Liege
- State
- BE-WLG
- Postal Code
- 4000
- Country
- BE
US Agent
- Business Name
- CEFALY US
- Contact Name
- Andy Page
- Address
- 19 Old Kings Hwy S Ste 200
- City
- Darien
- State
- CT
- ZIP
- 06820
- Country
- US
- [email protected]
- Phone
- 650 9062334
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | PCC | Class 2 | Neurology | No | 2020-10-12 |
Proprietary Names
Cefaly Dual
CEFALY DUAL Enhanced
CEFALY Acute
Cefaly
CEFALY Connected & CeCe Migraine Management App
CEFALY Connected
CEFALY Enhanced
CEFALY
CEFALY Prevent
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Export Device to the United States But Perform No Other Operation on Device