Medfire Innovations Inc.

Medfire Innovations Inc. specializes in urine specimen collection kits intended for in vitro diagnostic (IVD) use. These devices, such as the Recopad system, are designed to collect and preserve urine samples for laboratory testing. The focus is on ensuring sample integrity for accurate diagnostic analysis.

Medfire Innovations Inc. is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework and compliance with U.S. medical device standards.

Medfire Innovations Inc.’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the medical device supply chain, allowing healthcare providers and regulators to verify product details.

Medfire Innovations Inc.’s urine specimen collection kits fall under Class I classification according to FDA regulations. This classification is typically assigned to low-risk devices where general controls are sufficient to ensure safety and effectiveness, such as simple collection tools with minimal risk to patients.