CUSTOM ASSEMBLIES, INC.

Custom Medical Specialties manufactures FDA-registered (1063382), ISO 13485-certified disposable medical devices in a Class 8 cleanroom facility in Pine Level, North Carolina. The company specializes in sterile and non-sterile tubing sets (infiltration, aspiration, injection lines), universal drain bags, and custom pre-assembled procedure kits for IV therapy, urology, plastic surgery, and imaging applications. Products are assembled, packaged, and sterilized in-house with full 21 CFR Part 820 compliance. Beyond standard offerings, the company provides contract manufacturing, private labeling, and custom configurations tailored to healthcare provider specifications. With 30 years of operational experience and relationships with 43,000+ healthcare facilities, Custom Medical Specialties emphasizes supply chain reliability, same-day shipping capability, and direct customer support.