COPIOUMED INTERNATIONAL INC.

Copioumed International Inc. specializes in single-use protective and procedural garments. These include isolation gowns for infection control, professional examination gowns for clinical use, shoe covers for contamination prevention, patient gowns for comfort and protection, and patient surgical drapes for sterile field maintenance. All are designed for clinical and surgical environments to reduce contamination risks.

Copioumed International Inc. is based in Taiwan. While the company’s location influences its regulatory jurisdiction, its devices are classified under global standards (Class I and Class II) and are listed in key registries like the EU’s eudamed and the FDA’s 510(k) and UDI systems. Compliance depends on the device’s classification and the market requirements where they are sold, not the company itself.

Copioumed International Inc.’s devices are included in the EU’s eudamed database and the FDA’s 510(k) premarket notification registry and UDI (Unique Device Identification) system. These registries track medical devices by classification and manufacturer details, ensuring transparency for regulators and healthcare providers. Listing in these systems reflects compliance with respective regional requirements.

Copioumed International Inc.’s products are classified as either Class I or Class II medical devices. Class I devices generally pose minimal risk (e.g., basic protective garments) and often require general controls, while Class II devices involve moderate risk (e.g., surgical drapes) and may need special controls like performance standards or post-market surveillance. Classification determines regulatory oversight and compliance obligations.