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ElectroCore, Inc.

United States·US-MF-000036987

Last updated September 17, 2026

Information

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
gammaCore Sapphire Device Starter Kit	13016-04002	FDA UDI	Class II	Active
Ecor	12016-07002	EUDAMED	Class IIa	Active
Ecor	12016-07001 V	EUDAMED	Class IIa	Active
Ecor	12016-07594	EUDAMED	Class IIa	Active
Ecor	12016-08531	EUDAMED	Class IIa	Active
Ecor	12016-07001	EUDAMED	Class IIa	Active
Ecor	10016-20303 V	EUDAMED	Class IIa	Active
gammaCore Non-invasive Vagus Nerve Stimulator	DEN150048	FDA 510(k)	Class II	Active
gammaCore-S	K173442	FDA 510(k)	Class II	Active
gammaCore-S	K171306	FDA 510(k)	Class II	Active
Ecor	11016-08003	EUDAMED	Class IIa	Active
Ecor	40000-00103	EUDAMED	Class I	Active
Ecor	12016-02003	EUDAMED	Class IIa	Active
Ecor	12016-08003	EUDAMED	Class IIa	Active
Ecor	12016-08002 V	EUDAMED	Class IIa	Active
Ecor	10000-00001	EUDAMED	Class I	Active
Ecor	12016-08593 V	EUDAMED	Class IIa	Active
Ecor	10016-20302	EUDAMED	Class IIa	Active
Ecor	12016-02002	EUDAMED	Class IIa	Active
Ecor	12016-08001	EUDAMED	Class IIa	Active
Ecor	12016-02531	EUDAMED	Class IIa	Active
Ecor	12016-07002 V	EUDAMED	Class IIa	Active
SignaGel Branded Electrolyte Gel	10000-00002	EUDAMED	Class I	Active
Ecor	11016-02003	EUDAMED	Class IIa	Active
Ecor	12016-08594	EUDAMED	Class IIa	Active
Ecor	10016-23193	EUDAMED	Class IIa	Active
Ecor	12016-08531 V	EUDAMED	Class IIa	Active
Ecor	11016-02004	EUDAMED	Class IIa	Active
Ecor	10016-20303	EUDAMED	Class IIa	Active

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