Data / Medical devices / China / Shenzhen Airgle Corporation Limited
Shenzhen Airgle Corporation Limited: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
Shenzhen Airgle Corporation Limited is registered with the FDA (registration 3015139810) in Shenzhen Guangdong, China. It lists 4 device types. The FDA files 1 510(k) clearance under its listings, the newest dated February 16, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3015139810
- Address
- Zone A&B, The 11th Floor, KeChuang Building, QuanZhi Science & Technology Innovation Park Houting Maozhoushan Industrial Park, ShaJing Street, Baoan District, Shenzhen Guangdong, China, 518000
- Owner or operator
- SHENZHEN AIRGLE CORPORATION LIMITED (10059006)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- November 20, 2018
- Registered through
- 2026
- Brand names listed
- Airgle Clean Room Air Purifier, Models: AG900, AG900S, AG900L, AG900E, AG930, AG930S, AG930L, AG930E, Airgle Commercial Ventilation System, Models: AG2000, AG3000, Airgle Extraoral Dental Smart FlexHose, Models: AG600D, AG900D, Airgle Face Mask, Models: AM120, AM120M, AM120W, AM120B, AM120G, AM100, AM100S, AM100M, AM100L, Airgle Fresh Air Ventilation System, Models: AG2000, Airgle Personal Air Purifier, Models: AG25, AG35, Airgle Room Air Purifier, Models: AG300, AG300S, AG300L, AG300E, AG320, AG320S, AG320L, AG320E, Airgle Room Air Purifier, Models: AG600, AG600S, AG600L, AG600E, AG700, AG700S, AG700L, AG700E
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Disinfectant, Medical Devices | LRJ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Mask, Gas, Anesthetic | BSJ | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Purifier, Air, Ultraviolet, Medical | FRA | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Saw, Manual And Accessories | GDR | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 16, 2024 | K232645 | Airgle Room Air Purifier | FRA | Substantially Equivalent | Airgle Corporation | accessdata.fda.gov |
Compare with other makers
- All makers of Saw, Manual And Accessories
- All makers of Disinfectant, Medical Devices
- All makers of Mask, Gas, Anesthetic
- All makers of Purifier, Air, Ultraviolet, Medical
Updated February 16, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.