Subdermal Needle Electrodes
- Risk class
- Class IIa
- CND nomenclatures code
- N010199
- Trade name
- Subdermal Needles
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 00816312020649
- Basic UDI
- 081631202TF001TW
- Version date
- January 10, 2025
- Manufacturer last update
- March 21, 2024
- Active status
- No
- Manufacturer name
- Rhythmlink International, LLC
- Country
- United States
- Country type
- NON_EU
- Address
- 1140 First Street South Columbia
- quality@rhythmlink.com
- Name
- mdi Europa GmbH
- SRN
- DE-AR-000006218
- Country
- Germany
- Address
- 71 Langenhagener Straße Langenhagen
- info@mdi-europa.com
- Competent authority
- DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover
- Applicable legislation
- MDR (REGULATION (EU) 2017/745 on medical devices)
- Placed on the market
- Belgium
- Market available
- Belgium:2024-11-01~None, France:2024-11-01~None, Germany:2024-11-01~None, Italy:2024-11-01~None, Spain:2024-11-01~None
- Human tissues
- No
- Animal tissues
- No
NEUROPHYSIOLOGY DEVICES - OTHER
Access comprehensive regulatory information for Subdermal Needle Electrodes 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 00816312020649 and manufactured by Rhythmlink International, LLC in United States.
This page provides complete registration details including trade name (Subdermal Needles), 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.