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CEFALY TECHNOLOGY

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30101880093010188009CEFALY TECHNOLOGY1N2026-01-01Boulevard Patience et Beaujonc 3 bte 28 Liege Liege BE 4000

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
05425018850174Cefaly® - CEFALY Enhanced Electrode Kit .3 electrodes(203) 309-5670info@cefaly.us
05425018850181Cefaly® - Hypoallergenic Electrode CEFALY Enhanced Kit (3 electrodes)(203) 309-5670info@cefaly.us
05425018850273Cefaly® - Cefaly DUAL Enhanced is a newer version of Cefaly DUAL which is an FDA - cleared device Indications for Use:CEFALY DUAL Enhanced is for patients diagnosed by a physician with migraines per the FDA cleared indications for use.CEFALY DUAL Enhanced is indicated to be used for:The acute treatment of migraine with or without aura in patients 18 years of age or older.The preventative treatment of episodic migraine in patients 18 years of age or older.1-844-475-7100info@cefaly.us

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1690631956981493K234029CEFALY Connected - OTC, CEFALY Connected - RxPCC2024-07-18
1690631787783569K212071Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - RxPCC2022-12-13
1690631692657577K201895Cefaly DualPCC2020-09-29
1690631466358408K173006Cefaly DualPCC2017-11-28
1690631547360913K171446Cefaly AcutePCC2017-09-15
1690631593823873K160237CefalyPCC2016-03-04
1690632061638052DEN120019CEFALYPCC2014-03-11

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
PCC72024-07-18

PMN#

GUDID#