Delta Molding LLC

Delta Molding LLC specializes in patient medical adhesive removers, which are designed to safely and effectively remove medical adhesives from skin. These devices help reduce irritation, residue, and discomfort caused by adhesive products used in clinical settings or by patients. Their portfolio includes topical removers and adhesive-specific cleansers tailored for medical use.

Delta Molding LLC is based in the United States. Their devices are listed in regulatory databases such as EUDAMED (the EU’s medical device database) and the FDA’s Unique Device Identifier (UDI) system, indicating their presence in both European and U.S. markets. This reflects compliance with relevant regulatory requirements in those regions.

Delta Molding LLC’s devices are classified as Class I medical devices. This classification is typically assigned to low-risk products, such as adhesive removers, where the risk to patients is minimal. Class I devices often undergo general controls rather than specific regulatory scrutiny, though compliance with manufacturing and labeling standards remains mandatory.

Delta Molding LLC’s devices are listed in EUDAMED, the European Union’s medical device registry, and the FDA’s UDI system, which assigns unique identifiers to medical devices in the U.S. These listings help ensure traceability, transparency, and compliance with regulatory requirements in both markets.