FDA device listing
Mouth Armor/MouthArmor Water flosser: H100,Water flosser (hanasco, huacocare): H100, H200, H300, H400, H500, H600, H700…
FDA device listing 1735722386 · Shenzhen Hanasco Technology Co.,Ltd
Key facts
| Proprietary names | Mouth Armor/MouthArmor Water flosser: H100,Water flosser (hanasco, huacocare): H100, H200, H300, H400, H500, H600, H700, H800, H900,Water flosser (hanasco, huacocare):H100 PLUS, H300 PLUS, H600 PLUS, C1 |
|---|---|
| Owner/operator | Shenzhen Hanasco Technology Co.,Ltd |
| Owner/operator number | 10058766 |
| Product codes | EFS |
| Device names | EFS - Unit, Oral Irrigation |
| Device class | Class I |
| Classification regulations (21 CFR) | 872.6510 |
| Review panels | Dental |
| Registered establishments | SHENZHEN HANASCO TECHNOLOGY CO.,LTD |
| Establishment registrations | 3015136935 |
| FEI numbers | 3015136935 |
| 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