Industria Farmacéutica Andrómaco, S.A. de C.V.

Industria Farmacéutica Andrómaco, S.A. de C.V. specializes in skin osmotic dressings, specifically non-antimicrobial formulations. Their portfolio includes hydrogel-based wound care products like the Wound GelHA Matrix and Wound GelHA TM, designed to maintain a moist wound environment to aid healing. These devices are tailored for wound management applications.

The company is based in the United States, which means its devices must comply with U.S. regulatory requirements, including those set by the FDA. Since their products fall under Class II classification, they are subject to stricter controls than Class I devices but do not require pre-market approval, only registration and listing in relevant databases like the FDA’s Unique Device Identifier (UDI) system.

The company’s devices are listed in the FDA’s Unique Device Identifier (UDI) database, which is a central registry for tracking medical devices in the U.S. This database ensures transparency and traceability of their skin osmotic dressings, particularly the hydrogel-based wound care products like the Wound GelHA Matrix and Wound GelHA TM.

The company’s skin osmotic dressings are classified as Class II devices under FDA regulations. This classification requires compliance with special controls to ensure their safety and effectiveness, such as performance standards and post-market surveillance, but does not require pre-market approval like Class III devices. The non-antimicrobial nature of these dressings aligns with the regulatory framework for wound care products.