Airsonett AB
US Last updated 25 May 2026
- Devices
- 3
- Registries
- GUDIDFDA 510(k)EUDAMEDFDA
- FDA recalls
- 0
Catalogue
Airsonett AIR-4 A-1100 Ref A-1100
Airsonnett Airshower Air 3 Ref K081062
Airsonett Air-4 Ref K130702
FDA establishments
- Airsonett Ab Angelholm Skane · SE FEI 3004793042
What Airsonett AB makes
Airsonett AB manufactures mobile laminar airflow units designed for controlled air purification and filtration in clinical or cleanroom environments. These devices are portable and intended to maintain sterile or low-particulate environments by delivering high-efficiency airflow.
The company’s products are regulated as Class II medical devices in the US, with records supporting 510(k) clearance and UDI compliance. The devices are listed under FDA regulatory pathways.
Frequently asked questions
What types of medical devices does Airsonett AB manufacture?
Airsonett AB specializes in mobile laminar airflow units, which are portable devices designed to create controlled, sterile, or low-particulate environments. These units are primarily used in clinical settings or cleanroom applications where air purity and filtration are critical to maintaining a contamination-free workspace.
Where is Airsonett AB based, and how does that affect its regulatory oversight?
Airsonett AB is based in the United States, which means its devices fall under FDA regulation. Since the company’s products are classified as Class II medical devices, they must comply with FDA requirements, including 510(k) clearance for market authorization and UDI (Unique Device Identification) compliance to ensure traceability and tracking.
Which regulatory registries or databases list Airsonett AB’s devices?
Airsonett AB’s devices are documented in FDA registries, specifically through the 510(k) premarket notification process and UDI compliance listings. These registries confirm that the devices meet FDA requirements for Class II medical devices, ensuring they are authorized for distribution in the US market.
How are Airsonett AB’s devices classified under US medical device regulations?
Airsonett AB’s mobile laminar airflow units are classified as Class II medical devices under US regulations. This classification means they pose a moderate risk and require premarket notification (510(k)) to demonstrate substantial equivalence to a legally marketed predicate device before commercial distribution.
Information
- Country
- US
- DUNS number
- 775813962