FDA Registration
Active
🇨🇳 China
Chongqing Sonmol Technology Co., Ltd.
Reg #: 3021235837
·
FEI: 3021235837
·
Expires 2026
Products
8
Proprietary Names
7
Establishment Types
3
Classifications
8
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Registration Details
- Registration Name
- Chongqing Sonmol Technology Co., Ltd.
- Registration Number
- 3021235837
- FEI Number
- 3021235837
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No. 19 Ruihe Road, Shuitu Subdistrict, Liangjiang New Area
- City
- Chongqing
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K203196
Owner / Operator
- Firm Name
- Chongqing Sonmol Technology Co., Ltd.
- Operator Number
- 10083174
- Address
- No. 19 Ruihe Road, Shuitu Subdistrict, Liangjiang New Area
- City
- Chongqing
- State
- CN-NOTA
- Postal Code
- 400799
- Country
- CN
- Correspondent
- Yongxu Li
US Agent
- Business Name
- Regrek LLC
- Contact Name
- Leeyeo Kee
- Address
- 19 Holly Cove Ln.
- City
- Dover
- State
- DE
- ZIP
- 19901
- Country
- US
- [email protected]
- Phone
- 302 6089028
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Catheters, Suction, Tracheobronchial | BSY | Class 1 | Anesthesiology | No | 2021-10-31 |
| Irrigator, Sinus | KAR | Class 1 | Ear, Nose, Throat | No | 2021-10-31 |
| Exerciser, Non-Measuring | ION | Class 1 | Physical Medicine | No | 2021-10-31 |
| Meter, Peak Flow, Spirometry | BZH | Class 2 | Anesthesiology | No | 2022-01-05 |
| Humidifier, Non-Direct Patient Interface (Home-Use) | KFZ | Class 1 | Anesthesiology | No | 2022-08-29 |
| Irrigator, Powered Nasal | KMA | Class 1 | Ear, Nose, Throat | No | 2021-10-31 |
| Percussor, Powered-Electric | BYI | Class 2 | Anesthesiology | No | 2024-12-26 |
| Exerciser, Measuring | ISD | Class 2 | Physical Medicine | No | 2022-08-29 |
Proprietary Names
Nasal Aspirator
Nasal Rinse Salt Package, Nasal Irrigator
Respiratory Muscle Trainer
Peak Flow Meter
Handheld steam inhaler
Nasal Irrigator
Respiratory muscle trainer with manometer
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)