FDA device listing
EON; Forte MA; HA-802, HA-900; OIDO Hearing(MA);,POCO SA; POCO X, POCO X403, POCO X405, POCO X406, POCO X601, POCO X808…
FDA device listing 1689507288 · Xiamen NewSound Technology Co., Ltd
Key facts
| Proprietary names | EON; Forte MA; HA-802, HA-900; OIDO Hearing(MA);,POCO SA; POCO X, POCO X403, POCO X405, POCO X406, POCO X601, POCO X808, POCO X818,;,Primo SA, Primo RA, Primo MA; Sigma+; Sona; Ulite2000 |
|---|---|
| Owner/operator | Xiamen NewSound Technology Co., Ltd |
| Owner/operator number | 10028806 |
| 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 | XIAMEN NEWSOUND TECHNOLOGY CO., LTD |
| Establishment registrations | 3007694978 |
| FEI numbers | 3007694978 |
| Establishment operations | Contract Manufacturer, Manufacturer |
| 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