⭳ NIPT analysis software
⭳ MagPure Circulating DNA Kit & Universal DNA Library Prep Kit
⭳ Vacuum Blood Collection System
At Vangenes Biotech, we are proud to demonstrate our unwavering commitment to global quality, safety, and regulatory compliance.
EU IVDR Registration & Notifications
Our company’s in-vitro diagnostic (IVD) products—including the Vangenes NIPT analysis software, Vacuum Blood Collection System, MagPure Circulating DNA Kit, and Universal DNA Library Prep Kit—have completed the notification and registration process under the latest European In Vitro Diagnostic Regulation (EU) 2017/746 (IVDR). All products are officially registered with the Dutch Ministry of Health and can be legally marketed within the European Union.
Registered Products and Notified Identifiers:
- Vangenes NIPT analysis software
- Vacuum Blood Collection System (NL-CA002-2022-71947)
- MagPure Circulating DNA Kit (NL-CA002-2024-80074)
- Universal DNA Library Prep Kit (NL-CA002-2024-80075)
Our European Authorized Representative, SUNGO Europe B.V. (Netherlands), ensures smooth regulatory communications and market access throughout Europe.
Strict Compliance with Harmonized Standards
We adhere to stringent international and European harmonized standards, including:
- EN ISO 14971:2019 (Risk management for medical devices)
- EN ISO 20417:2021 (Manufacturer-provided information for medical devices)
- EN ISO 18113-1:2024 (Information supplied by the manufacturer of IVD reagents)
- EN ISO 15223-1:2021 (Symbols on medical device labeling)
Commitment to Transparency
Our registration with European authorities ensures that all necessary product and safety information is available through the appropriate regulatory channels, and we maintain traceability and regulatory documentation by EU requirements. This enables us to provide our European customers with innovative, reliable, and fully compliant diagnostic solutions.
As we continue to expand globally, Vangenes will always prioritize product safety, scientific reliability, and strict compliance with all international standards, helping our customers and partners advance healthcare with confidence.