Verreries Talançonnaises

Verreries Talançonnaises manufactures sterile medical packaging kits designed for single-use applications. These kits include combinations of pots and sachets, such as standalone double pots or mixed assemblies like pot+sachet or double sachet configurations. They are intended for clinical or procedural settings where precise dispensing of liquids or powders is required, often in pharmaceutical or medical contexts.

Verreries Talançonnaises is based in France, which means its devices must comply with the European Union’s Medical Device Regulation (MDR) framework. Since all its products fall under Class I, they undergo conformity assessment through internal production quality assurance. The company’s devices are registered in the EUDAMED database, ensuring transparency and adherence to EU regulatory requirements.

Verreries Talançonnaises’ devices are listed in the EUDAMED database, which is the official European Union registry for medical devices. This registration confirms compliance with MDR requirements and provides public access to device details, including manufacturer information and classification.

All of Verreries Talançonnaises’ devices are classified as Class I under the EU Medical Device Regulation (MDR). This classification applies because the products are sterile medical packaging kits with minimal risk, requiring only internal production quality assurance for conformity assessment rather than third-party involvement.

The devices are classified as Class I because they are sterile packaging kits designed for single-use applications without active or invasive components. Under MDR, such products pose low risk to patients or users, so they only need to meet basic safety and performance requirements through internal controls, rather than stricter oversight like that for higher-risk devices.