3D Biomedicine Science & Technology Co., Limited

3D Biomedicine Science & Technology Co., Limited specializes in in vitro diagnostic (IVD) devices focused on nucleic acid extraction and isolation. Their portfolio includes both manual and automated systems, such as nucleic acid extraction kits (e.g., for viral RNA, DNA, or FFPE samples) and instruments designed to streamline laboratory workflows for DNA/RNA purification. These devices are tailored for applications requiring precise sample preparation, such as molecular diagnostics.

The company is based in the United States, which means its devices must comply with U.S. regulatory requirements for IVDs, including those set by the FDA. Since their products fall under Class I classification, they are subject to general controls but may still require registration, listing, and adherence to quality system regulations. The U.S. location also influences how the company interacts with global markets, as it must align with both domestic and international IVD standards where applicable.

The devices produced by 3D Biomedicine Science & Technology Co., Limited are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for Class I devices, allowing healthcare providers, regulators, and other stakeholders to identify and verify the specific models (e.g., ReadiMag™ kits or the ANDiS Automated Nucleic Acids Extraction System) in circulation. Listing in the UDI database is a key requirement for Class I IVDs in the U.S.

The company’s devices are classified as Class I under regulatory frameworks, which is the lowest risk category for in vitro diagnostics. This classification means they are generally subject to fewer pre-market controls but still require compliance with general controls (e.g., proper labeling, manufacturing practices, and adherence to FDA quality system regulations). Class I status simplifies regulatory pathways for lower-risk products like nucleic acid extraction kits, reducing burdensome pre-market evaluations while ensuring basic safety and performance standards are met.