Manufacturer

ElectroCore

United StatesLegal entities : ElectroCore, Inc., electroCore, Inc.

Markets : Belgium · Denmark · Finland · France · Germany · Latvia · United States

Approvals : EU – class IIa · United States (FDA) – 510(k) : 8 · class II · latest in 2021 · see on the FDA website

EU representative : MDSS GmbH (Germany)

Website info@electrocore.com

2 categories, 20 models including 15 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Neurological stimulators	Z12101106	ECOR gammaCore Sapphire D Evaluation Device Kit 36-month Preprogrammed93/42 ECOR gammaCore Sapphire Device Kit 31-Days2 refs93/42 ECOR gammaCore Sapphire Device Kit 93-days2 refs93/42 ECOR gammaCore Sapphire Refill Card Kit 31-days93/42 ECOR gammaCore Sapphire Refill Card Kit, 93-days93/42 14 others ECOR gammaCore Sapphire SLC 93 Day Evaluation Kit (kit with refill card)93/42 ECOR gammaCore Sapphire SLC Device Kit 31-Days (Kit with refill card)6 refs93/42 ECOR gammaCore Sapphire SLC Device Kit 93-Days (Kit with refill card)5 refs93/42 ECOR gammaCore Sapphire SLC Device Kit, 93 Day (kit with refill card)93/42 ECOR gammaCore Sapphire SLC Refill Card Kit 31-Days4 refs93/42 ECOR gammaCore Sapphire SLC Refill Card Kit 93-Days5 refs93/42 gammaCore Sapphire 31-Day Starter Kit3 refs gammaCore Sapphire SLC EVAL Refill Card Kit gammaCore Sapphire SLC Evaluation Refill Card Kit93/42 gammaCore Sapphire SLC Refill Card Kit, 31 days93/42 ECOR gammaCore Sapphire D Device Kit 36-Month Preprogrammed3 refs93/42 (no longer marketed) ECOR gammaCore Sapphire SLC Device Kit for Evaluation (kit with refill card)93/42 (no longer marketed) ECOR gammaCore Sapphire SLC Evaluation Kit 93-Day ( Kit with refill card)93/42 (no longer marketed) ECOR gammaCore Sapphire SLC Refill Card Evaluation Kit93/42 (no longer marketed) ECOR gammaCore Sapphire SLC Refill Card Evaluation Kit 93-days93/42 (no longer marketed)	IIa MDR, 93/42	EUDAMED record Report an error
Peripheral or central neuro stimulation and assessment instruments - hardware accessories	Z12101180	Refill Card, 1-Month3 refs	IIa MDR	EUDAMED record Report an error

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