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EUDAMED registration 00815203020744Yes

gammaCore Sapphire SLC

ElectroCore, Inc.Class IIaEU EUDAMEDTrade name: ECOR
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIa
CND nomenclatures code
Z12101106
Trade name
ECOR
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
00815203020744
Basic UDI
B-00815203020744
Active status
Yes
Manufacturer
Manufacturer name
ElectroCore, Inc.
Country
United States
Country type
NON_EU
Address
200 Forge Way Rockaway
Email
info@electrocore.com
Authorized representative
Name
MDSS GmbH
SRN
DE-AR-000005430
Country
Germany
Address
41 Schiffgraben Hannover
Email
info@mdssar.com
Regulatory information
Competent authority
DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover
Applicable legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed on the market
Belgium
Market available
Belgium:None~None, France:None~None, Germany:None~None, Greece:None~None, Italy:None~None, Portugal:None~None, Spain:None~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

NEUROLOGICAL STIMULATORS

About this record

Access comprehensive regulatory information for gammaCore Sapphire SLC in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 00815203020744 and manufactured by ElectroCore, Inc. in United States.

This page provides complete registration details including trade name (ECOR), manufacturer information, authorized representative details, competent authority (DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.