Lasec International (Pty) Ltd

Lasec International (Pty) Ltd specializes in dried blood spot collection kits, specifically Whatman cards without capillary tubes. These kits are designed for collecting blood samples in laboratory settings, typically supplied in packs of 20 tests. The devices are intended for use in diagnostic testing and sample analysis.

Lasec International (Pty) Ltd is based in South Africa. The company’s location is relevant for understanding its operational and regulatory context, particularly for devices intended for global markets.

Lasec International (Pty) Ltd’s devices are listed in the eudamed database, which is the European Union’s central registry for medical devices. This registry is used to track and monitor devices authorized within the EU, ensuring transparency and compliance with regulatory requirements.

Lasec International (Pty) Ltd’s dried blood spot collection kits fall under EU Device Class IIa. This classification is determined by factors such as the device’s intended use, potential risks, and the level of regulatory oversight required. Class IIa devices are considered to pose a moderate risk and require compliance with specific EU Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) requirements.