Certificate
ISO 13485 Certification
PentaBase A/S is proud to hold an EU Quality Management System Certificate under Regulation (EU) 2017/746 (IVDR) (Certificate No. IVDR 790049 R000), issued by BSI Group (Notified Body 2797).
This certification confirms that our quality management system complies with Annex IX, Chapter I and III of the IVDR, covering the design, development, and manufacture of in vitro diagnostic medical devices. The scope includes Class C in vitro diagnostic polymerase chain reaction (PCR) assays for the analysis of DNA mutations for the diagnosis of cancer, as specified in the attached device schedule IVDR 790049 R000.
The certificate was first issued on 20 January 2026 and is valid until 19 January 2031, subject to ongoing surveillance and compliance with regulatory requirements IVDR 790049 R000.
Our IVDR certification demonstrates that PentaBase A/S operates a robust and compliant quality management system aligned with the most stringent European regulatory standards for in vitro diagnostics. It reflects our commitment to delivering reliable, accurate, and clinically relevant molecular diagnostic solutions that meet regulatory expectations and support high-quality patient care.
Last updated: March 2026