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Phonak Target 10.1
FDA UDIEUDAMEDClass II (US FDA UDI)
Ref 088-0125-100Model Sonova hearing aid fitting software
by Sonova AG
Identity
- Trade Name
- Phonak Target 10 EUDAMEDFDA UDIPhonak Target 10.1 FDA UDI
- Generic Name
- Audiometric/hearing device software FDA UDI
- Device Name
- Sonova hearing aid fitting software EUDAMED
- Model / Reference
- Sonova hearing aid fitting software EUDAMED088-0125-100 EUDAMED10.1 FDA UDI10.0 FDA UDI
Identifiers
- Catalog Number
- 088-0125-101 FDA UDI088-0125-100 FDA UDI
- Primary DI / UDI-DI
- 07613389716115 EUDAMEDFDA UDI07613389769814 FDA UDI
- Basic UDI-DI
- 07613389SWAQ EUDAMED
- FDA Product Code
- OSM FDA UDI
- EMDN Code
- Y214599 HEARING AIDS - OTHER 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
- Germany 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Audiometric/hearing device software
Phonak Target 10.1 by Sonova AG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Audiometric/hearing device software.
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- Unitron — Unitron Hearing Division · Class II
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 29922c02-1908-4639-b72a-e104e14f8daf 33 fields · synced Jul 27, 2026
- FDA UDI a897e0b3-28e2-4662-a6b5-f729dee9ae01 33 fields · synced May 30, 2026
- EUDAMED 7d4fbad8-aee2-4a96-8f21-e97ed9614355 61 fields · synced Jul 27, 2026