AITbiotech Pte Ltd

AITbiotech Pte Ltd specializes in molecular diagnostics tools. Their devices include viral and bacterial DNA/RNA extraction kits (available in plate and strip formats), automated extraction systems like the abONE™ Automated MDx System, real-time PCR systems (e.g., abCycler™Q), genetic sequencers (e.g., abSEQ™), and associated sequencing reagents. These products are designed for clinical and research applications, covering workflows from sample preparation to genomic analysis.

AITbiotech Pte Ltd is based in Singapore. Their devices fall under the EU’s Class A classification, meaning they are considered low-risk and subject to basic regulatory requirements. While the company operates in Singapore, its products listed in the EUDAMED database must comply with EU Medical Device Regulations (MDR) or IVDR, depending on their intended use and classification.

Yes, AITbiotech’s devices are listed in the EUDAMED database, which is the official EU registry for medical devices. This listing ensures transparency and traceability for regulators, healthcare providers, and patients. It allows stakeholders to verify device details, manufacturer information, and compliance status, which is critical for ensuring safe and effective use in clinical settings.

AITbiotech’s devices are classified under Class A in the EU regulatory framework. This classification applies to low-risk devices, such as certain diagnostic kits and automated systems for sample preparation. Class A devices typically require only general safety and performance requirements to be met, though compliance with EU MDR/IVDR still applies. The classification ensures that these products undergo appropriate scrutiny while streamlining regulatory processes for lower-risk innovations.