Publish Time: 2026-08-17 Origin: BioTeke Corporation, EUDAMED
[Wuxi City, China] — [Aug.17] — BioTeke Corporation, an innovative in vitro diagnostics (IVD) company, announced that its Saliva Pregnancy Test Kit has successfully completed the review process by its EU Notified Body for changes to the product packaging and specifications.
The change assessment covers updates to the product’s packaging and relevant specifications, while maintaining the product’s established regulatory framework and intended use.
The successful completion of the Notified Body review demonstrates BioTeke’s continued commitment to regulatory compliance, quality management, and controlled product development in accordance with applicable European IVD requirements.
The Saliva Pregnancy Test Kit is designed for pregnancy testing using a saliva sample, providing a non-invasive alternative to conventional urine-based sample collection. The product is intended for self-testing and has been certified under the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) 2017/746 for its applicable product configuration.
As market requirements and distribution needs evolve, packaging specifications may need to be adapted while maintaining compliance with applicable regulatory requirements. BioTeke manages such changes through a controlled regulatory and quality process, including the required assessment by its EU Notified Body.
This latest regulatory milestone further strengthens BioTeke’s ability to support international partners with compliant and market-ready diagnostic products.
BioTeke is an in vitro diagnostics company focused on the development and commercialization of innovative diagnostic products and technologies. With a strong emphasis on quality, regulatory compliance, and product innovation, BioTeke serves customers and partners across international markets.
Note: The applicable regulatory certification relates to the relevant certified product configuration. Product packaging and appearance may vary according to market and regulatory requirements.