EUDAMED registration 00815203021895NoSignaGel Branded Electrolyte Gel
- Risk class
- Class I
- CND nomenclatures code
- V9015
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 00815203021895
- Basic UDI
- B-00815203021895
- Active status
- No
- Manufacturer name
- ElectroCore, Inc.
- Country
- United States
- Country type
- NON_EU
- Address
- 200 Forge Way Rockaway
- info@electrocore.com
- Name
- MDSS GmbH
- SRN
- DE-AR-000005430
- Country
- Germany
- Address
- 41 Schiffgraben Hannover
- info@mdssar.com
- 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, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Italy:None~None, Latvia:None~None, Lithuania:None~None, Norway:None~None, Portugal:None~None, Romania:None~None, Spain:None~None, Sweden:None~None
- Human tissues
- No
- Animal tissues
- No
ELECTRODES AND PROBES CUTANEOUS CONDUCTIVE SUBSTANCES
Access comprehensive regulatory information for SignaGel Branded Electrolyte Gel in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 00815203021895 and manufactured by ElectroCore, Inc. in United States.
This page provides complete registration details including 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.