Chongqing Sonmol Technology Co., Ltd.
Registered establishment in Chongqing, China. 9 device types.
Chongqing Sonmol Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Irrigator, Sinus, Exerciser, Measuring and 7 other device types. Its earliest product listing with the FDA dates from 2021.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3021235837 |
| FEI number | 3021235837 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Location
| City | Chongqing |
|---|---|
| Province | Chongqing |
| Address | No. 19 Ruihe Road, Shuitu Subdistrict, Liangjiang New Area |
| Postal code | 400799 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Catheters, Suction, Tracheobronchial | Class 1 | Nasal Aspirator | 2021 | 93 |
| Exerciser, Measuring | Class 2 | Respiratory muscle trainer with manometer | 2022 | 14 |
| Exerciser, Non-Measuring | Class 1 | Respiratory Muscle Trainer | 2021 | 82 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | Class 1 | Handheld steam inhaler | 2022 | 55 |
| Irrigator, Powered Nasal | Class 1 | Nasal Irrigator | 2021 | 63 |
| Irrigator, Sinus | Class 1 | Nasal Rinse Salt Package, Nasal Irrigator | 2021 | 27 |
| Meter, Peak Flow, Spirometry | Class 2 | Peak Flow Meter | 2022 | 6 |
| Percussor, Powered-Electric | Class 2 | Respiratory Muscle Trainer | 2024 | 1 |
| Pump, Nebulizer, Manual | Class 1 | EPMDI, Breath-Actuated Pressurized Metered-Dose Inhaler, THE SMARTASSISTANT, UMEP-A1 | 2026 | 11 |
Clearances
No clearance names Chongqing Sonmol Technology Co., Ltd. as applicant. 3 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K241338 | 2024-12-31 | BZH | Traditional | Chongqing Moffy Innovation Technology Co., Ltd. |
| K240959 | 2024-12-18 | BYI | Traditional | Chongqing Moffy Innovation Technology Co., Ltd. |
| K203196 | 2021-05-26 | BZH | Traditional | Shanghai Sonmol Medical Equipment Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2014 |
|---|---|
| Main products | Anti-choking devices, Peak flow meters, Respiratory exercise devices, Nasal irrigation systems, Household health products |
| Export markets | 20+ countries |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.