Svizera Europe BV

Svizera Europe BV specializes in diagnostic consumable kits, specifically the Auramine V4 and Ziehl Neelsen (ZN) V4 kits. These products are designed for microbiological testing to identify acid-fast bacilli, such as those found in tuberculosis screening. They are intended for use in laboratory environments to assist in detecting and confirming mycobacterial infections.

Svizera Europe BV is headquartered in the Netherlands, where it operates as a manufacturer of its diagnostic consumable kits.

Svizera Europe BV’s diagnostic consumable kits are registered in the EUDAMED database, which is the European Union’s medical device registry. This listing ensures transparency and compliance with EU regulatory requirements.

Svizera Europe BV’s diagnostic consumable kits are classified as Class A medical devices under the EU Medical Device Regulation (MDR). This classification applies because the kits are low-risk consumables used for in vitro diagnostic purposes, primarily for identifying specific bacteria in clinical samples.