Identity
- Trade Name
- Unitron TrueFit 5.7 DVD FDA UDI
- Generic Name
- Audiometric/hearing device software FDA UDI
- Model / Reference
- n/a FDA UDI
Identifiers
- Catalog Number
- 058-5178-057 FDA UDI
- Primary DI / UDI-DI
- 07613389736267 FDA UDI
- FDA Product Code
- ESD FDA UDI
- GMDN Term
- Audiometric/hearing device software FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 874.3300 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
Yes
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 UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Audiometric/hearing device software
Unitron TrueFit 5.7 DVD by Sonova AG — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Audiometric/hearing device software.
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- 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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Sonova AG
Sources (1)
- FDA UDI 6b68cf2b-e2dc-46c7-ba56-56716f33fa15 34 fields · synced May 30, 2026