Identity
- Trade Name
- DVD Phonak Target 10.1 DVD FDA UDI
- Generic Name
- Audiometric/hearing device software FDA UDI
- Model / Reference
- 10.1 DVD FDA UDI
Identifiers
- Catalog Number
- 058-0125-101 FDA UDI
- Primary DI / UDI-DI
- 07613389769821 FDA UDI
- FDA Product Code
- OSM FDA UDI
- GMDN Term
- Audiometric/hearing device software FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 874.3305 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
DVD Phonak Target 10.1 DVD 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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- Widex — Widex A/S · Class I
- Nucleus — Cochlear · Class III
- hearX — INTRICON CORPORATION · Class II
- GN Hearing — Gn Hearing A/S · Class II
- GN ReSound — Gn Hearing A/S · Class II
- CUSTOM SOUND SUITE 3.2 ENGLISH (US) — Cochlear · Class III
- 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 (2)
- FDA UDI e8d006b1-4b20-46e9-b224-2105df2f41e5 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 18, 2026