Profile Therapeutics PLC
Country not established
- Devices
- 3
What Profile Therapeutics PLC makes
Profile Therapeutics Plc manufactures aerosol drug delivery systems designed for respiratory treatments, including the I-NEB AAD System, I-NEB Insight AAD System, and ProDose AAD System. These devices are intended for nebulizing medications to the lungs, supporting conditions requiring precise inhalation therapy.
The company’s products are classified as Class II medical devices under FDA regulations and are authorised via the 510(k) pathway. The portfolio is listed in the FDA’s 510(k) database, and the company is headquartered in the United States.
Catalogue
I-Neb Aad System Ref K042991
Regimes: 510(k) Registry: 510(k)I-Neb Insight Aad System Ref K052941
Regimes: 510(k) Registry: 510(k)Prodose Aad System Ref K030747
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Profile Therapeutics Plc have in the registry?
The registry currently lists 3 devices for Profile Therapeutics Plc. Devices recorded under merged duplicate company entries are counted once.
Which registries list Profile Therapeutics Plc's devices?
Among its 3 most recently registered devices, Profile Therapeutics Plc has devices listed in FDA 510(k) (3 devices).
What risk classes do Profile Therapeutics Plc's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Profile Therapeutics Plc's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Profile Therapeutics Plc in the registry?
The most recently registered devices listed for Profile Therapeutics Plc include I-NEB AAD SYSTEM, I-NEB INSIGHT AAD SYSTEM and PRODOSE AAD SYSTEM.