Identity
- Trade Name
- Cefaly® FDA UDI
- Generic Name
- Craniofacial analgesia electrical stimulator FDA UDI
- Device Name
- CEFALY Connected is indicated to be used for: Acute treatment of migraine with or without aura in patients 18 years of age or older. Preventative treatment of migraine in patients 18 years of age or older. FDA UDI
- Model / Reference
- CEFALY Connected FDA UDI
- Description
- CEFALY Connected is indicated to be used for: Acute treatment of migraine with or without aura in patients 18 years of age or older. Preventative treatment of migraine in patients 18 years of age or older. FDA UDI
Identifiers
- Catalog Number
- 10801 FDA UDI
- Primary DI / UDI-DI
- 05425018850297 FDA UDI
- 510(k) Number
- K212071 FDA UDI
- FDA Product Code
- PCC FDA UDI
- GMDN Term
- Craniofacial analgesia electrical stimulator FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 882.5891 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Craniofacial analgesia electrical stimulator
Cefaly® by Cefaly Technology SPRL — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K212071 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Cefaly Technology SPRL
Sources (1)
- FDA UDI 298cc7fc-6361-4b94-a3d6-1b50586cb39c 37 fields · synced May 30, 2026