FDA device listing
QUG BTE Digital Hearing Aids:GM-100,GM-101,GM-102,GM-103,GM-111,GM-112,GM-113,GM-114,GM-121,GM-122,GM-123,GM-124,GM-130…
FDA device listing 1291886174 · Goodmi Intelligent (Shenzhen) Co.,Ltd.
Key facts
| Proprietary names | QUG BTE Digital Hearing Aids:GM-100,GM-101,GM-102,GM-103,GM-111,GM-112,GM-113,GM-114,GM-121,GM-122,GM-123,GM-124,GM-130,,QUG BTE Digital Hearing Aids:GM-131,GM-132,GM-133,GM-140,GM-141,GM-142,GM-143,GM-150,GM-151,GM-152,GM-153,GM-160,GM-161,,QUG BTE Digital Hearing Aids:GM-162,GM-163,GM-170,GM-171,GM-172,GM-173,GM-180,GM-181,GM-182,GM-183,GM-190,GM191,GM-192,,QUG BTE Digital Hearing… |
|---|---|
| Owner/operator | Goodmi Intelligent (Shenzhen) Co.,Ltd. |
| Owner/operator number | 10091158 |
| 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 | GOODMI INTELLIGENT (SHENZHEN) CO.,LTD. |
| Establishment registrations | 3023007429 |
| FEI numbers | 3023007429 |
| 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