Patrin Pharma

Patrin Pharma specializes in antimicrobial wound irrigation solutions, specifically hypochlorous acid-based formulations. These products are designed for clinical use in wound cleansing and debridement, including ready-to-use irrigation solutions and scrub formulations. The focus is on reducing microbial load in both acute and chronic wounds.

Patrin Pharma is based in the United States, which means its devices are subject to FDA regulations. Since the company’s products are authorised through pathways like the 510(k) and De Novo processes, they must comply with US regulatory standards for medical devices, including classification under the FDA’s device hierarchy.

Patrin Pharma’s devices are classified as Class II medical devices under FDA regulations. This classification applies to products that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness. Class II devices require pre-market submission (like 510(k) or De Novo) to demonstrate compliance with these controls before they can be marketed.

Patrin Pharma’s devices are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) registries. Inclusion in these databases indicates that the company’s products have undergone the necessary pre-market authorisation processes (such as 510(k) clearance or De Novo pathway approval) and are assigned a UDI for traceability and regulatory tracking in the US market.