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Sonova hearing aid software - EUDAMED Registration 07613389595338

Access comprehensive regulatory information for Sonova hearing aid software 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 07613389595338 and manufactured by Sonova AG in Switzerland.

This page provides complete registration details including trade name (EasyLine Remote 6.4), manufacturer information, authorized representative details, competent authority (DE/CA37, Regierungspräsidium Stuttgart), 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
07613389595338
Yes
Sonova hearing aid software
Trade Name: EasyLine Remote 6.4
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Device Description (EMDN)

HEARING AIDS - OTHER

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Y214599
Trade Name
EasyLine Remote 6.4
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
07613389595338
Basic UDI
07613389SWAQ
Version Date
September 15, 2023
Manufacturer Last Update
November 04, 2021
Active Status
Yes
Manufacturer
Manufacturer Name
Sonova AG
Country
Switzerland
Country Type
NON_EU
Address
28 Laubisruetistrasse Staefa
Email
bente-iris.eller@sonova.com
Authorized Representative
SRN
DE-AR-000006322
Country
Germany
Address
20 Max-Eyth-Str. Fellbach-Oeffingen
Email
bente-iris.eller@sonova.com
Telephone
+49 711 51070145
Regulatory Information
Competent Authority
DE/CA37, Regierungspräsidium Stuttgart
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Austria
Market Available
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Turkey:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No