Foshan Gaunying Electronics Co., Ltd.
Registered establishment in Foshan, Guangdong, China. 4 device types, 6 clearances.
Foshan Gaunying Electronics Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Lamp, Infrared, Therapeutic Heating, Nebulizer (Direct Patient Interface) and 2 other device types. Its earliest product listing with the FDA dates from 2011.
4device types registered with the FDA
6510(k) clearances
Registration
| Registered name | FOSHAN GAUNYING ELECTRONICS CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008395118 |
| FEI number | 3008395118 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 佛山广鹰电子有限公司 |
|---|---|
| Unified social credit code | 91440600617638514R |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Foshan |
|---|---|
| Province | Guangdong |
| Address | No. 501, 5th Floor, Building 5, No. 51, Jiang Hai Road |
| Postal code | 528000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Humidifier, Non-Direct Patient Interface (Home-Use) | Class 1 | 2014 | 55 | |
| Lamp, Infrared, Therapeutic Heating | Class 2 | Gaunying Infrared Lamp FIR51, SN-51 | 2011 | 235 |
| Nebulizer (Direct Patient Interface) | Class 2 | 2013 | 42 | |
| Nebulizer, Medicinal, Non-Ventilatory (Atomizer) | Class 1 | Personal Inhaler, Model NM211A (NB30), Mesh Atomizer Model: NM212, NM232, Mesh Atomizer Model: NM222 | 2015 | 57 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K140211 | 2014-05-30 | CAF | Special | This company |
| K132247 | 2014-01-08 | CAF | Traditional | This company |
| K121154 | 2012-08-20 | CAF | Traditional | This company |
| K110721 | 2011-03-30 | ILY | Traditional | This company |
| K101693 | 2011-01-05 | ILY | Traditional | This company |
| K102149 | 2010-08-13 | ILY | Traditional | This company |
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.