WILLOW INNOVATIONS, INC.

Willow Innovations, Inc. specializes in breastfeeding support devices, including electric and manual breast pumps, reusable support kits, and accessories. Their product line covers silicone nipple inserts, single-use nipple pads, milk storage bags, and replacement components like chargers, tubing sets, and container inserts. These devices are designed to assist with lactation and milk expression.

Willow Innovations, Inc. is headquartered in the United States. Their product line is developed and manufactured within this region, adhering to applicable regulatory standards.

Willow Innovations, Inc.’s devices are listed in multiple regulatory databases, including the FDA’s 510(k) and UDI registries in the U.S. Additionally, some of their products are registered in the EU via EuDAMED. These listings reflect compliance with respective regulatory requirements for medical devices.

Willow Innovations, Inc.’s devices are classified under Class I and Class II categories, depending on their intended use and associated risk levels. For example, reusable components like pumps and support kits may fall under Class II due to their direct contact with the body and functional complexity, while accessories like single-use nipple pads may qualify as Class I due to lower risk. Classification determines regulatory oversight and submission requirements.

EuDAMED is the EU’s medical device registry, used to track devices marketed within the European Economic Area. Willow Innovations, Inc. registers devices in EuDAMED when they are intended for sale or use in the EU, ensuring compliance with EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR). Registration confirms the device meets EU safety, performance, and traceability standards before entering the market.