Shenzhen Airgle Corporation Limited
Registered establishment in Shenzhen, Guangdong, China. 4 device types.
Shenzhen Airgle Corporation Limited is a manufacturer holding a current FDA establishment registration. The registration covers Mask, Gas, Anesthetic, Saw, Manual And Accessories and 2 other device types. Its earliest product listing with the FDA dates from 2018.
Registration
| Registered name | SHENZHEN AIRGLE CORPORATION LIMITED |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3015139810 |
| FEI number | 3015139810 |
| Establishment type | Manufacturer, Exporter |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Zone A&B, The 11th Floor, KeChuang Building, QuanZhi Science & Technology Innovation Park |
| Postal code | 518000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Disinfectant, Medical Devices | Class 1 | Airgle Commercial Ventilation System, Models: AG2000, AG3000, Airgle Fresh Air Ventilation System, Models: AG2000, Airgle Personal Air Purifier, Models: AG25, AG35 | 2018 | 197 |
| Mask, Gas, Anesthetic | Class 1 | Airgle Face Mask, Models: AM120, AM120M, AM120W, AM120B, AM120G, AM100, AM100S, AM100M, AM100L | 2018 | 71 |
| Purifier, Air, Ultraviolet, Medical | Class 2 | Airgle Room Air Purifier, Models: AG600, AG600S, AG600L, AG600E, AG700, AG700S, AG700L, AG700E, Airgle Room Air Purifier, Models: AG300, AG300S, AG300L, AG300E, AG320, AG320S, AG320L, AG320E, Airgle Clean Room Air Purifier, Models: AG900, AG900S, AG900L, AG900E, AG930, AG930S, AG930L, AG930E | 2026 | 2 |
| Saw, Manual And Accessories | Class 1 | Airgle Extraoral Dental Smart FlexHose, Models: AG600D, AG900D | 2020 | 4 |
Clearances
No clearance names Shenzhen Airgle Corporation Limited as applicant. One is held by another company 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 |
|---|---|---|---|---|
| K232645 | 2024-02-16 | FRA | Traditional | Airgle Corporation |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1999 |
|---|---|
| Main products | air purifiers, masks, filter networks |
| Export markets | worldwide including USA, Saudi Arabia, Qatar, Kuwait, Germany, UK, Denmark, South Korea, Japan, Singapore, Vietnam, Thailand, Malaysia, Myanmar, India |
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.