FDA device listing
ampli-charge R 3,ampli-charge R 4 6P T PH,ampli-charge R AI 3 5P FP,ampli-connect R L PH,ampli-connect R Trial…
FDA device listing 1648667977 · Sonova AG
Key facts
| Proprietary names | ampli-charge R 3,ampli-charge R 4 6P T PH,ampli-charge R AI 3 5P FP,ampli-connect R L PH,ampli-connect R Trial L,ampli-energy B L RP PH,ampli-energy B Trial L,ampli-energy R 5P R PH,ampli-energy R Trial 5P,ampli-mini E 5P R-R AI PH,ampli-mini E 6P RITE-R AI PH,ampli-mini E 6P R-R PH,ampli-mini E D 5P R-R AI PH,ampli-mini I 5P CIC-10 NWL PH,ampli-mini R L PH,Au 3,Au B,Au Basic+,AudioNova… |
|---|---|
| Owner/operator | Sonova AG |
| Owner/operator number | 9028479 |
| Premarket submissions | K123450 |
| Product codes | KLW |
| Device names | KLW - Masker, Tinnitus |
| Device class | Class II |
| Classification regulations (21 CFR) | 874.3400 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | Sonova AG, Sonova Hearing (Suzhou) Co., Ltd., Sonova North American Operations Center S.A.de C.V, Sonova Operations Center Vietnam Company Ltd, SONOVA SERVICE CENTER UK LIMITED, Sonova USA Inc., Unitron Hearing, a division of National Hearing Services Inc. |
| Establishment registrations | 3002808415, 3004929038, 3005085999, 3006312495, 3008848788, 3027487235, 3036679760 |
| FEI numbers | 3002808415, 3004929038, 3005085999, 3006312495, 3008848788, 3027487235, 3036679760 |
| Establishment operations | Complaint File Establishment, Manufacturer, Repackager/Relabeler, Contract Manufacturer, Specification Developer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database