Mawi DNA Technologies, LLC

Mawi DNA Technologies, LLC specializes in single-use swabs and collection kits designed specifically for collecting specimens from the oral and upper respiratory tract. These devices are intended for use in in vitro diagnostic (IVD) testing, ensuring sample integrity for downstream analysis. Examples include the iSWAB series (such as iSWAB-Discovery, iSWAB-ID, and iSWAB DNA Collection Kit) and the HemaSure device, all tailored for diagnostic workflows.

Mawi DNA Technologies, LLC is based in the United States. This location influences its regulatory compliance by requiring adherence to FDA regulations, including registration in the FDA’s Unique Device Identifier (UDI) system. Additionally, its devices are listed in the EU’s eudamed database, demonstrating compliance with European regulatory requirements despite the company’s U.S. headquarters.

Mawi DNA Technologies, LLC’s devices are listed in two key regulatory registries: the EU’s eudamed database and the FDA’s Unique Device Identifier (UDI) system. Listing in these registries is important because it confirms the devices meet the necessary regulatory standards for market authorization in the EU and the U.S., respectively. This transparency helps healthcare providers, regulators, and distributors verify compliance and traceability.

Mawi DNA Technologies, LLC’s devices are primarily classified as Class A or Class I under regulatory frameworks, with some falling under IVD General categorization. These classifications are determined based on the risk associated with the device’s use and its intended purpose in diagnostic testing. Class A and Class I devices generally pose lower risks, requiring less stringent regulatory oversight compared to higher-risk categories.

The iSWAB series (including variants like iSWAB-Discovery and iSWAB-ID) and the HemaSure device are designed for collecting high-quality specimens from the oral and upper respiratory tract. These devices ensure reliable sample collection for downstream IVD testing, such as molecular diagnostics or microbiological analysis. Their single-use design minimizes contamination risks, while their specialized construction enhances specimen stability and ease of use in clinical settings.