FDA device listing
Hearing Aid(108(TE), 1108A(TE), 1108B(TE), 308(TE), 3308A(TE), 3308B(TE), 316(TE), 216(TE), 1208A(TE)…
FDA device listing 1263235015 · Tomore Medical (Shenzhen) Co., Ltd
Key facts
| Proprietary names | Hearing Aid(108(TE), 1108A(TE), 1108B(TE), 308(TE), 3308A(TE), 3308B(TE), 316(TE), 216(TE), 1208A(TE), 1208B(TE)),Hearing Aid(1216AE(TE), 1216BE(TE), 1118(TE), 1120(TE), 1122(TE), 1124(TE), 7116T(TE), 7116(TE), 1216TE(TE), 508OE(TE)),Hearing Aid(5116A(TE), 5116B(TE), 5216A(TE), 5216B(TE), 5216C(TE), 5116AE(TE), 5216AE(TE), 5118L(TE), 5118H(TE)),Hearing Aid(5118DL(TE), 5118DH(TE), 5116DL(TE)… |
|---|---|
| Owner/operator | Tomore Medical (Shenzhen) Co., Ltd |
| Owner/operator number | 10081686 |
| Product codes | QUG |
| Device names | QUG - Hearing Aid, Air-Conduction With Wireless Technology, Over The Counter |
| Device class | Class II |
| Classification regulations (21 CFR) | 874.3305 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | Tomore Medical (Shenzhen) Co., Ltd |
| Establishment registrations | 3019414808 |
| FEI numbers | 3019414808 |
| Establishment operations | 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