FDA device listing
Afflelou Incognito Edge AI,Afflelou Incognito GS,Afflelou Incognito OM AI,Afflelou Incognito OM AI+,Amplifon…
FDA device listing 1517697302 · Starkey Laboratories, Inc.
Key facts
| Proprietary names | Afflelou Incognito Edge AI,Afflelou Incognito GS,Afflelou Incognito OM AI,Afflelou Incognito OM AI+,Amplifon AMPLI-CONNECT,Amplifon AMPLI-CROS,Amplifon ampli-energy,Amplifon AMPLI-ENERGY,Amplifon AMPLI-MINI,Amplifon AMPLI-POWER,Amplifon REMOTE MICROPHONE 2.0 2.4 GH LE UNBRANDED ST,AMPLI-MINI E 7S,AMPLI-TV 2.0 LE ST,AMPLITV Streamer,Audibel A2,Audibel A3,Audibel A3i,Audibel A4,Audibel A4i,Audibel… |
|---|---|
| Owner/operator | Starkey Laboratories, Inc. |
| Owner/operator number | 2125608 |
| Product codes | OSM |
| Device names | OSM - Hearing Aid, Air-Conduction With Wireless Technology, Prescription |
| Device class | Class II |
| Classification regulations (21 CFR) | 874.3305 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | STARKEY DE MEXICO, S.A. DE C.V., STARKEY GLENCOE, Starkey Global Distribution Center, Starkey Laboratories, Inc., STARKEY (Suzhou) Hearing Technology Co, LTD. |
| Establishment registrations | 2125608, 2183732, 3002159143, 3006544364, 3019622583 |
| FEI numbers | 2125608, 2183732, 3002159143, 3006544364, 3019622583 |
| Establishment operations | Manufacturer, Repackager/Relabeler |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None listed 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