Vista V-PR Select
FDA UDIEUDAMEDClass II (US FDA UDI)
by Sonova AG
Identity
- Trade Name
- Vista V-PR Select (pewter) EUDAMEDVista V-PR Select FDA UDI
- Generic Name
- Air-conduction hearing aid, behind-the-ear FDA UDI
- Device Name
- Sonova BTE hearing aids EUDAMED
- Model / Reference
- Sonova BTE hearing aids EUDAMED050-6857-P744 EUDAMEDpewter FDA UDI
Identifiers
- Catalog Number
- 050-6857-P744 FDA UDI
- Primary DI / UDI-DI
- 07613389657005 EUDAMEDFDA UDI
- Basic UDI-DI
- 07613389BTEV7 EUDAMED
- FDA Product Code
- OSM FDA UDI
- EMDN Code
- Y2145060101 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE) EUDAMED
- GMDN Term
- Air-conduction hearing aid, behind-the-ear FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3305 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Air-conduction hearing aid, behind-the-ear
Vista V-PR Select by Sonova AG — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction hearing aid, behind-the-ear.
- Oticon — Oticon A/S · Class II
- Phonak — Phonak, Inc. · Class II
- GN ReSound — Gn Hearing A/S · Class II
- Miracle-Ear — WS Audiology USA, Inc. · Class II
- NUEAR — Starkey Laboratories Inc. · Class II
- HHM — Oticon A/S · Class II
- Signia — WS Audiology USA, Inc. · Class II
- Hansaton — Hansaton Akustik GmbH · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 4a982ed3-8202-487f-be28-18d7b5e68d48 34 fields · synced Sep 17, 2026
- EUDAMED 1e167c47-aedd-4f8e-9e6f-62489898dd14 61 fields · synced Sep 17, 2026