Aerobiotix
Air purification ULPA Carbon F Filter Assembly
2manufacturers in China registered for this device type
5catalogue numbers in this listing
Who Else Makes It
All of them in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou | Guangdong | Manufacturer | 13 |
| Shenzhen Airgle Corporation Limited | Shenzhen | Guangdong | Manufacturer | 4 |
Record
| Listed by | Aerobiotix USA, United States |
|---|---|
| FDA product code | FRA |
| Device type | Purifier, Air, Ultraviolet, Medical |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6500 |
| Establishment | Manufacturer |
| 510(k) | K203189 |
| Record published | 2022-11-15 |
| Record revised | 2026-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AeroCure Vac Hose XL | In distribution | |
| AeroCure Vac HEPA Filter Assembly | In distribution | |
| AeroCure-MD | In distribution | |
| ULPA Carbon F Filter | In distribution | |
| AeroCure Vac | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Airgle | Airgle Corporation | 10 |
| RGF-BioControls | RGF Environmental Group, Inc | 9 |
| ADS | Guangzhou Ajax Medical Equipment Co Ltd | 5 |
| Molekule Air Mini + | Molekule Group, Inc. | 2 |
| Molekule | Molekule Group, Inc. | 1 |
| The Pyure Company | The Pyure Company Inc | 1 |
| ActivePure Medical Guardian | Activepure Medical LLC | 1 |
| Purgo | Molekule Group, Inc. | 1 |
| RGS mini | Genesis AIR, Inc. | 1 |
| Medical Guardian | Aerus Medical, LLC | 1 |
| RGS | Genesis AIR, Inc. | 1 |
| Molekule Air Pro | Molekule Group, Inc. | 1 |
Showing 12 of 13. All products under Purifier, Air, Ultraviolet, Medical
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.