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Subdermal Needle Electrodes - EUDAMED Registration 00816312020694

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 00816312020694 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.

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EUDAMED Official Data
Class IIa
00816312020694
No
Subdermal Needle Electrodes
Trade Name: Subdermal Needles
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Device Description (EMDN)

NEUROPHYSIOLOGY DEVICES - OTHER

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
N010199
Trade Name
Subdermal Needles
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00816312020694
Basic UDI
081631202TF001TW
Version Date
January 10, 2025
Manufacturer Last Update
March 21, 2024
Active Status
No
Manufacturer
Country
United States
Country Type
NON_EU
Address
1140 First Street South Columbia
Email
quality@rhythmlink.com
Authorized Representative
SRN
DE-AR-000006218
Country
Germany
Address
71 Langenhagener StraรŸe Langenhagen
Email
info@mdi-europa.com
Regulatory Information
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
Device Characteristics
Human Tissues
No
Animal Tissues
No