# ElectroCore, Inc.

> Medical device manufacturer record on deviCERTS, compiled from public registries. ElectroCore, Inc. is a medical device manufacturer based in the United States, with 122 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II; EU Class IIa and I) as of 15 Nov 2026.

- Canonical page: <https://devicerts.com/manufacturers/electrocore-inc>
- Also registered as: ELECTROCORE, LLC
- Country: United States (from SRN)
- EUDAMED actor status: active
- Role: Manufacturer
- Registrations: EUDAMED, FDA
- EUDAMED SRN: US-MF-000036987
- FDA FEI: 3015529603
- DUNS: 831341628

## Figures

- Devices: 122
- FDA recalls (matched to the firm by name): 0

## Registry facts

*Every device of the manufacturer. A device listed in two registries counts in both.*

- Registries: FDA GUDID 86, EUDAMED 36, FDA 510(k) 3
- Device classes: FDA Class II 89, EU Class IIa 30, EU Class I 3
- EMDN [Z12 Instruments for functional explorations and therapeutic interventions](https://devicerts.com/categories/emdn/Z12): 30 devices
- EMDN [V90 Various devices not included in other classes](https://devicerts.com/categories/emdn/V90): 3 devices

## Sites and related companies

- Authorised representative: [MDSS GmbH](https://devicerts.com/representatives/mdss-gmbh-de-ar-000005430) (Germany)

## Devices

The first 50 of 122, in the order of the canonical page, which lists them all.

- [gammaCore Sapphire SLC Refill Card Kit, 93 days](https://devicerts.com/devices/gammacore-sapphire-slc-refill-card-kit-93-days-12016-02593) · ref 12016-02593 · Class IIa · EUDAMED · status: Active
- [gammaCore Sapphire SLC - Evaluation Refill Card Kit](https://devicerts.com/devices/gammacore-sapphire-slc-evaluation-refill-card-kit-12016-02594) · ref 12016-02594 · Class IIa · EUDAMED · status: Active
- [gammaCore Sapphire 6-Month Evaluation Device Kit](https://devicerts.com/devices/gammacore-sapphire-6-month-evaluation-device-kit-12016-02003) · ref 12016-02003 · Class IIa · EUDAMED · status: Active
- [gammaCore Sapphire 20016-00301-RPL](https://devicerts.com/devices/gammacore-sapphire-20016-00301-rpl) · Class II · GUDID · status: Listed
- [gammaCore Sapphire 20016-00501-RPL](https://devicerts.com/devices/gammacore-sapphire-20016-00501-rpl) · Class II · GUDID · status: Listed
- [gammaCore Sapphire 13016-04501-C](https://devicerts.com/devices/gammacore-sapphire-13016-04501-c) · Class II · GUDID · status: Listed
- [gammaCore Sapphire 13016-04502-C](https://devicerts.com/devices/gammacore-sapphire-13016-04502-c) · Class II · GUDID · status: Listed
- [gammaCore Sapphire 13016-04504-C](https://devicerts.com/devices/gammacore-sapphire-13016-04504-c) · Class II · GUDID · status: Listed
- [gammaCore Sapphire 12016-04999](https://devicerts.com/devices/gammacore-sapphire-12016-04999) · Class II · GUDID · status: Listed
- [gammaCore Sapphire AC Power Adapter 20016-00001-RPL](https://devicerts.com/devices/gammacore-sapphire-ac-power-adapter-20016-00001-rpl) · Class II · GUDID · status: Listed
- [gammaCore 20016-00003-RPL](https://devicerts.com/devices/gammacore-20016-00003-rpl) · Class II · GUDID · status: Listed
- [gammaCore 20016-00006-RPL](https://devicerts.com/devices/gammacore-20016-00006-rpl) · Class II · GUDID · status: Listed
- [gammaCore Emerald 3-Month Device Kit 12116-04003](https://devicerts.com/devices/gammacore-emerald-3-month-device-kit-12116-04003) · Class II · GUDID · status: Listed
- [gammaCore Emerald 12-Month Device Kit 12116-04012](https://devicerts.com/devices/gammacore-emerald-12-month-device-kit-12116-04012) · Class II · GUDID · status: Listed
- [gammaCore Emerald-D Device Kit 12116-04036](https://devicerts.com/devices/gammacore-emerald-d-device-kit-12116-04036) · Class II · GUDID · status: Listed
- [gammaCore Emerald 6-Month Evaluation Device Kit 11116-04006](https://devicerts.com/devices/gammacore-emerald-6-month-evaluation-device-kit-11116-04006) · Class II · GUDID · status: Listed
- [gammaCore 1-Month Refill Kit 12116-04501](https://devicerts.com/devices/gammacore-1-month-refill-kit-12116-04501) · Class II · GUDID · status: Listed
- [gammaCore 3-Month Refill Kit 12116-04503](https://devicerts.com/devices/gammacore-3-month-refill-kit-12116-04503) · Class II · GUDID · status: Listed
- [gammaCore 6-Month Evaluation Refill Kit 11116-04506](https://devicerts.com/devices/gammacore-6-month-evaluation-refill-kit-11116-04506) · Class II · GUDID · status: Listed
- [gammaCore 12-Month Refill Kit 12116-04512](https://devicerts.com/devices/gammacore-12-month-refill-kit-12116-04512) · Class II · GUDID · status: Listed
- [gammaCore Emerald 1-Month Licensed Device Kit 13116-04001](https://devicerts.com/devices/gammacore-emerald-1-month-licensed-device-kit-13116-04001) · Class II · GUDID · status: Listed
- [gammaCore Emerald 3-Month Licensed Device Kit 13116-04003](https://devicerts.com/devices/gammacore-emerald-3-month-licensed-device-kit-13116-04003) · Class II · GUDID · status: Listed
- [gammaCore Emerald 36-Month Licensed Device Kit 13116-04036](https://devicerts.com/devices/gammacore-emerald-36-month-licensed-device-kit-13116-04036) · Class II · GUDID · status: Listed
- [gammaCore Emerald 12-Month Licensed Device Kit 13116-04012](https://devicerts.com/devices/gammacore-emerald-12-month-licensed-device-kit-13116-04012) · Class II · GUDID · status: Listed
- [gammaCore 1-Month Card 12116-04501-C](https://devicerts.com/devices/gammacore-1-month-card-12116-04501-c) · Class II · GUDID · status: Listed
- [gammaCore 12-Month Card 12116-04512-C](https://devicerts.com/devices/gammacore-12-month-card-12116-04512-c) · Class II · GUDID · status: Listed
- [gammaCore 3-Month Card 12116-04503-C](https://devicerts.com/devices/gammacore-3-month-card-12116-04503-c) · Class II · GUDID · status: Listed
- [gammaCore Emerald Handset - Replacement 12116-04901-RPL](https://devicerts.com/devices/gammacore-emerald-handset-replacement-12116-04901-rpl) · Class II · GUDID · status: Listed
- [gammaCore Emerald Replacement Charging Pad 12116-04902-RPL](https://devicerts.com/devices/gammacore-emerald-replacement-charging-pad-12116-04902-rpl) · Class II · GUDID · status: Listed
- [gammaCore Emerald Replacement USB Cable 12116-04903-RPL](https://devicerts.com/devices/gammacore-emerald-replacement-usb-cable-12116-04903-rpl) · Class II · GUDID · status: Listed
- [gammaCore Emerald Replacement Power Block 12116-04904-RPL](https://devicerts.com/devices/gammacore-emerald-replacement-power-block-12116-04904-rpl) · Class II · GUDID · status: Listed
- [gammaCore Sapphire 20016-00502-RPL](https://devicerts.com/devices/gammacore-sapphire-20016-00502-rpl) · Class II · GUDID · status: Listed
- [gammaCore Emerald 20116-00001-RPL](https://devicerts.com/devices/gammacore-emerald-20116-00001-rpl) · Class II · GUDID · status: Listed
- [gammaCore Emerald 20116-10301-RPL](https://devicerts.com/devices/gammacore-emerald-20116-10301-rpl) · Class II · GUDID · status: Listed
- [gammaCore Emerald 50022-00004-RPL](https://devicerts.com/devices/gammacore-emerald-50022-00004-rpl) · Class II · GUDID · status: Listed
- [gammaCore Emerald 50022-00078-RPL](https://devicerts.com/devices/gammacore-emerald-50022-00078-rpl) · Class II · GUDID · status: Listed
- [gmmaCore - Refill Card 12116-00501-C](https://devicerts.com/devices/gmmacore-refill-card-12116-00501-c) · Class II · EUDAMED, GUDID · status: Active
- [gammaCore Refill Card 12116-00503-C](https://devicerts.com/devices/gammacore-refill-card-12116-00503-c) · Class II · EUDAMED, GUDID · status: Active
- [gammaCore Refill Card 12116-00512-C](https://devicerts.com/devices/gammacore-refill-card-12116-00512-c) · Class II · EUDAMED, GUDID · status: Active
- [gammaCore Sapphire SLC Handset - Replacement](https://devicerts.com/devices/gammacore-sapphire-slc-handset-replacement-20016-10301-rpl) · ref 20016-10301-RPL · Class IIa · EUDAMED · status: Active
- [gammaCore Sapphire 93-Day Device Kit (For Trial Use)](https://devicerts.com/devices/gammacore-sapphire-93-day-device-kit-for-trial-use-12016-02002-v) · ref 12016-02002 v · Class IIa · EUDAMED · status: Active
- [gammaCore Sapphire 31-Day Starter Kit](https://devicerts.com/devices/gammacore-sapphire-31-day-starter-kit-12016-02001) · ref 12016-02001 · Class IIa · EUDAMED · status: Active
- [gammaCore Sapphire 93-DayStarter Kit](https://devicerts.com/devices/gammacore-sapphire-93-daystarter-kit-12016-02002) · ref 12016-02002 · Class IIa · EUDAMED · status: Active
- [gammaCore Sapphire Charging Station / Case - Replacement](https://devicerts.com/devices/gammacore-sapphire-charging-station-case-replacement-20016-10501-rpl) · ref 20016-10501-RPL · Class IIa · EUDAMED · status: Active
- [Replacement AC Power Adapter Blade Kit](https://devicerts.com/devices/replacement-ac-power-adapter-blade-kit-20016-00002-rpl) · ref 20016-00002-RPL · Class IIa · EUDAMED · status: Active
- [gammaCore-2 10016-40311](https://devicerts.com/devices/gammacore-2-10016-40311) · Class II · GUDID · status: Listed
- [gammaCore Sapphire D 11016-40302](https://devicerts.com/devices/gammacore-sapphire-d-11016-40302) · Class II · GUDID · status: Listed
- [gammaCore Sapphire 3 11016-40301](https://devicerts.com/devices/gammacore-sapphire-3-11016-40301) · Class II · GUDID · status: Listed
- [gammaCore Sapphire SLC DEMO Device Kit 14016-04004](https://devicerts.com/devices/gammacore-sapphire-slc-demo-device-kit-14016-04004) · Class II · GUDID · status: Listed
- [gammaCore Sapphire SLC DEMO Device Kit 13016-04008](https://devicerts.com/devices/gammacore-sapphire-slc-demo-device-kit-13016-04008) · Class II · GUDID · status: Listed

## Source and citation

- Cite as: ElectroCore, Inc. deviCERTS medical device catalogue. https://devicerts.com/manufacturers/electrocore-inc (data as of 2026-11-15).
- Data sources: [EUDAMED](https://ec.europa.eu/tools/eudamed), [FDA GUDID](https://accessgudid.nlm.nih.gov/), [FDA 510(k)](https://open.fda.gov/apis/device/510k/), [FDA registration and listing](https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfrl/rl.cfm)
- EUDAMED record synced: 2026-11-07
- FDA recall data as of: 2026-11-01
- Data as of: 2026-11-15
- JSON: <https://devicerts.com/manufacturers/electrocore-inc.json>
- Licence: [CC BY 4.0](https://creativecommons.org/licenses/by/4.0/). The deviCERTS layout and text are licensed under CC BY 4.0. Registry data remain under their source terms: U.S. FDA data (openFDA, AccessGUDID) are U.S. public domain; EUDAMED data are subject to the European Commission reuse terms.
- Attribution: DevicErts, https://devicerts.com/manufacturers/electrocore-inc
- Compiled by deviCERTS (devicerts.com) from public medical device registries (EUDAMED, European Commission; U.S. FDA via openFDA; AccessGUDID, U.S. National Library of Medicine). deviCERTS is not an official register and gives no regulatory advice: the record in the registry itself prevails.