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Sonova RIC hearing aids - EUDAMED Registration 07613389350869

Access comprehensive regulatory information for Sonova RIC hearing aids 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 07613389350869 and manufactured by Sonova AG in Switzerland.

This page provides complete registration details including trade name (Phonak Audéo P90-312), 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
07613389350869
Yes
Sonova RIC hearing aids
Trade Name: Phonak Audéo P90-312
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Device Description (EMDN)

BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE)

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Y2145060102
Trade Name
Phonak Audéo P90-312
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
07613389350869
Basic UDI
07613389RICWJ
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
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, Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No