Cefaly Technology SPRL

Address:Rue Louis Plescia 34,Seraing Liege,BE

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Stimulator, Nerve, Electrical, Transcutaneous, For Migraine (PCC) (10)

Premarket Exempt

Clear

Cefaly® - 05425018850044 Catalog Number :

Device Description : Kit 3 electrodes for Cefaly I

Device Class :

Duns Number: 762450752

Premarket Exempt : No

Product Code : PCC

Prescription Use : No

Device Count : 3

Cefaly® - 05425018850105 Catalog Number :

Device Description : Kit 3 electrodes Blue Gel for Cefaly I

Device Class :

Duns Number: 762450752

Premarket Exempt : No

Product Code : PCC

Prescription Use : No

Device Count : 3

Cefaly® - 05425018850129 Catalog Number :

Device Description : Set Cefaly® :- Instruction manual- Cefaly® device- Cefaly® electrode- Storage bo Set Cefaly® :- Instruction manual- Cefaly® device- Cefaly® electrode- Storage box- Power adapter + cable

Device Class : 2

Duns Number: 762450752

Premarket Exempt : No

Product Code : PCC

Prescription Use : Yes

Device Count : 1

Cefaly® - 05425018850143 Catalog Number :

Device Description : Kit 3 electrodes for Cefaly II

Device Class :

Duns Number: 762450752

Premarket Exempt : No

Product Code : PCC

Prescription Use : No

Device Count : 3

Cefaly® - 05425018850150 Catalog Number :

Device Description : Kit 3 Electrodes Blue Gel for Cefaly II

Device Class :

Duns Number: 762450752

Premarket Exempt : No

Product Code : PCC

Prescription Use : No

Device Count : 3

Cefaly® - 05425018850242 Catalog Number : 10405

Device Description : The Cefaly® Acute device is indicated for the acute treatment of migraine with o The Cefaly® Acute device is indicated for the acute treatment of migraine with or without aura in patients 18 years of age or older.

Device Class : 2

Duns Number: 762450752

Premarket Exempt : No

Product Code : PCC

Prescription Use : Yes

Device Count : 1

Cefaly® - 05425018850259 Catalog Number : 10505

Device Description : The Cefaly® Dual device is indicated for:- The acute treatment of migraine with The Cefaly® Dual device is indicated for:- The acute treatment of migraine with or without aura in patients 18 years of age or older.- The prophylactic treatment of episodic migraine in patients 18 years of age or older.

Device Class : 2

Duns Number: 762450752

Premarket Exempt : No

Product Code : PCC

Prescription Use : Yes

Device Count : 1

Cefaly® - 05425018850266 Catalog Number : 10230

Device Description : The Cefaly® Prevent device is indicated for the prophylactic treatment of episod The Cefaly® Prevent device is indicated for the prophylactic treatment of episodic migraine in adults.

Device Class : 2

Duns Number: 762450752

Premarket Exempt : No

Product Code : PCC

Prescription Use : Yes

Device Count : 1

Cefaly® - 05425018850273 Catalog Number : 10601

Device Description : Cefaly DUAL Enhanced is a newer version of Cefaly DUAL which is an FDA - cleared 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.

Device Class : 2

Duns Number: 762450752

Premarket Exempt : No

Product Code : PCC

Prescription Use : No

Device Count : 1

Cefaly® - 05425018850303 Catalog Number :

Device Description : CEFALY Enhanced Electrode Kit .3 electrodes

Device Class : 2

Duns Number: 762450752

Premarket Exempt : No

Product Code : PCC

Prescription Use : No

Device Count : 3

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