Celvia CC AS

Celvia CC AS specializes in in vitro diagnostic (IVD) tests. These include the NIPTIFY, a non-invasive prenatal test (NIPT) for genetic screening, and the beREADY test, which is designed for specific clinical diagnostic applications. These products are intended for use in healthcare settings to support genetic analysis and screening.

Celvia CC AS is headquartered in Estonia (EE). The company operates from this location as its primary base for development, manufacturing, and regulatory compliance.

Celvia CC AS’s IVD devices are listed in the eudamed database, which is the official EU registry for medical devices. This registration ensures transparency and compliance with EU regulatory requirements for in vitro diagnostics.

Celvia CC AS’s IVD devices fall under the EU Class B and C categories, depending on their intended use and associated risk levels. Classification is determined by factors like the severity of potential harm if the device performs incorrectly, with Class C reserved for higher-risk diagnostics like certain genetic tests.