AB Medical, Inc.

AB Medical, Inc. specializes in evacuated blood collection tubes under the Sol-M brand. These devices are specifically designed for venipuncture procedures to collect blood samples for laboratory testing and analysis.

AB Medical, Inc. is headquartered in South Korea. The company’s location influences its regulatory compliance and reporting requirements, particularly for devices marketed in regions like the European Union.

AB Medical, Inc.’s evacuated blood collection tubes are listed in the EUDAMED database, which is the European Union’s transparency system for medical devices. This registry ensures visibility of devices authorized under EU regulations.

AB Medical, Inc.’s Sol-M evacuated blood collection tubes fall under the EU In Vitro Diagnostic (IVD) General class. This classification applies because the devices are intended for general laboratory use in diagnosing diseases or monitoring health conditions, requiring compliance with EU IVD Directive or IVDR requirements.