Cefaly®

FDA UDI

Class II (US FDA UDI)

by Cefaly Technology SPRL

Identity

Trade Name: Cefaly® FDA UDI
Generic Name: Craniofacial analgesia electrical stimulator FDA UDI
Device Name: Kit 3 Electrodes Blue Gel for Cefaly II FDA UDI
Model / Reference: 11202 FDA UDI
Description: Kit 3 Electrodes Blue Gel for Cefaly II FDA UDI

Identifiers

Primary DI / UDI-DI: 05425018850150 FDA UDI
510(k) Number: K160237 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

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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ELEXIR — Nu Eyne Co., Ltd. · Class II

Cleared under the same submission

K160237 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 b9e9b5b4-d366-4a39-80ac-ca648d5b6721 36 fields · synced May 30, 2026