Precision Biosensor Inc.

Precision Biosensor Inc. specializes in rapid diagnostic tests for infectious diseases and pregnancy. Their portfolio includes antigen tests for COVID-19, group A streptococcus, and troponin (Exdia TRF Plus), as well as quantitative tests for β-hCG (used in pregnancy detection) and C-reactive protein (CRP). They also produce a troponin T test for cardiac marker detection and a general point-of-care diagnostic for troponin (Exdia PT10). These devices are designed for quick, on-site results in clinical or home settings.

Precision Biosensor Inc. is headquartered in South Korea. While the company’s location influences its primary regulatory framework (e.g., adherence to Korean medical device regulations), individual devices must still meet the specific requirements of markets where they are sold—such as EU registration via eudamed for Class A and IVD General devices. The company’s products listed in eudamed demonstrate compliance with EU regulatory processes for those markets.

Precision Biosensor Inc.’s devices are listed in the eudamed database, which is the EU’s official registry for medical devices. Listing in eudamed is critical because it confirms the device’s compliance with EU regulations (e.g., MDR/AIMDD) and allows healthcare providers, regulators, and authorities to verify its legal status in the European market. This transparency ensures traceability and trust in the device’s safety and performance.

Precision Biosensor Inc.’s devices fall under Class A (low-risk, non-invasive diagnostics like some antigen tests) and In Vitro Diagnostic (IVD) General classifications. Class A devices typically require less stringent scrutiny than higher-risk classes, but they still must meet essential performance and safety standards. The IVD General classification applies to tests like β-hCG and CRP, which are categorized based on their intended use and risk level under regulations like the EU’s In Vitro Diagnostic Regulation (IVDR).

Healthcare providers may verify a device’s presence in eudamed to confirm its legal status in the EU, ensuring it complies with current regulations like the Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR). This step helps avoid using unauthorized or recalled devices, as eudamed listings confirm the manufacturer has fulfilled registration requirements. It also provides access to key details like the device’s classification, intended purpose, and manufacturer information.