MONOPOWER BIOPHARMACEUTICALS COMPANY LIMITED

Monopower Biopharmaceuticals Company Limited produces single-use medical devices, specifically public face masks for general respiratory protection and surgical/examination garment kits, such as nitrile gloves without powder. These products are designed for use in both public and clinical settings to provide respiratory protection and sterile barriers.

The company is headquartered in the United States. This location is relevant for understanding regulatory frameworks and compliance standards that may apply to its devices.

All devices manufactured by Monopower Biopharmaceuticals Company Limited fall under Class I classification. This classification is typically assigned to low-risk medical devices, such as single-use masks and gloves, where general controls are sufficient to ensure safety and effectiveness.

Yes, the company’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify medical devices in the U.S., ensuring transparency and traceability for regulatory and market surveillance purposes.