FDA device listing
electric ear washing device,ear cleaner device,Electric ear wax remover,Electric ear cleaner, Electric ear clean kit…
FDA device listing 1886469259 · Omedic Technology (Dongguan) Co., Ltd
Key facts
| Proprietary names | electric ear washing device ,ear cleaner device,Electric ear wax remover ,Electric ear cleaner , Electric ear clean kit , Ear irrigation device ,water ear pick ,,OME01,OME02,OME03,OMEO4, OME05,OME06,OME08,OME09,OME10,Z10,AN108,Y1,Y2, Y3, Y5 , Y6 ,Y7,Y8 |
|---|---|
| Owner/operator | Omedic Technology (Dongguan) Co., Ltd |
| Owner/operator number | 10084669 |
| Product codes | JYT |
| Device names | JYT - Pick, Microsurgical Ear |
| Device class | Class I |
| Classification regulations (21 CFR) | 874.4420 |
| Review panels | Ear, Nose, & Throat |
| Registered establishments | OMEDIC TECHNOLOGY (DONGGUAN) CO., LTD |
| Establishment registrations | 3022553912 |
| FEI numbers | 3022553912 |
| Establishment operations | Foreign Exporter, 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