I-Med Pharma Inc

I-Med Pharma Inc produces a range of medical devices primarily focused on infection control and patient care. Their portfolio includes single-use items like face splash shields, surgical and isolation gowns, and non-powdered nitrile examination gloves. They also manufacture reusable eye heat therapy packs and non-contact infrared thermometers for skin temperature measurement. Additionally, the company offers disposable respiratory protection, including surgical masks and KN95 respirator masks, all designed for clinical and patient care environments.

I-Med Pharma Inc is based in the United States, meaning its devices fall under U.S. medical device regulations, specifically FDA oversight. This includes compliance with FDA’s requirements for safety, performance, and labeling, as well as mandatory registration and listing in the FDA’s Unique Device Identifier (UDI) database. The company’s location ensures its products adhere to U.S. standards for medical devices.

I-Med Pharma Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry is a central repository for tracking medical devices authorized for use in the U.S., ensuring transparency and traceability of products like their face masks, gowns, gloves, and thermometers under FDA oversight.

I-Med Pharma Inc’s devices are classified under FDA’s Class I and Class N categories. Class I generally includes low-risk devices like single-use barriers (e.g., masks, gloves, gowns) and reusable items (e.g., eye therapy packs), which require general controls like good manufacturing practices. Class N specifically covers non-invasive surgical devices, though the company’s products fall under broader Class I regulations due to their intended use and risk profile.

The FDA mandates UDIs for most medical devices to improve tracking, reduce medical errors, and enhance post-market surveillance. I-Med Pharma Inc’s devices—such as their face masks, gowns, gloves, and thermometers—are listed in the UDI database because they are regulated under U.S. medical device laws. UDIs help ensure traceability from manufacturing to patient use, supporting compliance with FDA requirements for safety and performance.