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myAudioNova 2
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 088-0020-00042Model Sonova hearing aid mobile app
by Sonova AG
Identity
- Trade Name
- myAudioNova 4.2 EUDAMEDmyAudioNova 2 FDA UDImyAudioNova 4 FDA UDI
- Generic Name
- Audiometric/hearing device software FDA UDI
- Device Name
- Sonova hearing aid mobile app EUDAMED
- Model / Reference
- Sonova hearing aid mobile app EUDAMED088-0020-00042 EUDAMED2.2 FDA UDI4.2 FDA UDI
Identifiers
- Catalog Number
- 088-0020-00022 FDA UDI088-0020-00042 FDA UDI
- Primary DI / UDI-DI
- 07613389793932 EUDAMEDFDA UDI07613389700640 FDA UDI
- Basic UDI-DI
- 07613389APPSND EUDAMED
- FDA Product Code
- OSM FDA UDI
- EMDN Code
- Y214580 HEARING AIDS OR HEARING DEVICES - ACCESSORIES EUDAMED
- GMDN Term
- Audiometric/hearing device software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3305 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDIFDA UDI
Serial Number
Yes
FDA UDIFDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Audiometric/hearing device software
myAudioNova 2 by Sonova AG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Audiometric/hearing device software.
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Sonova AG
Sources (3)
- FDA UDI fa77f1e8-12b2-407f-9372-5990f2356e2e 33 fields · synced Jun 20, 2026
- FDA UDI c2357927-7436-4513-ae05-b93bcfea5bb4 33 fields · synced May 30, 2026
- EUDAMED eff77fc6-bd7d-4b4d-8d7f-9b6bc7e8d902 61 fields · synced Jun 20, 2026