FDA device listing
dental irrigator,MC3108,MC3109 MC3107,MC3110,S2009,Nasal irrigator, irrigator nasal, nose irrigator, nose water…
FDA device listing 2036428843 · Omedic Technology (Dongguan) Co., Ltd
Key facts
| Proprietary names | dental irrigator,MC3108,MC3109 MC3107,MC3110,S2009,Nasal irrigator, irrigator nasal, nose irrigator, nose water jet,OMN01,OMN02,OMN03,OMNO4, OMN05,OMN06,OMN08,OMN09,OMN10,OMT01,OMT02,OMT03,OMT05.,OMT06,OMT07,OMT08 ,OMT09,OMT10,,Oral irrigator ,dental oral irrigator ,irrigator oral , dental water jet ,water flosser , dental water flosser ,,water flosser pick ,cordless oral irrigator ,portable… |
|---|---|
| Owner/operator | Omedic Technology (Dongguan) Co., Ltd |
| Owner/operator number | 10084669 |
| Product codes | KMA |
| Device names | KMA - Irrigator, Powered Nasal |
| Device class | Class I |
| Classification regulations (21 CFR) | 874.5550 |
| 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