This is another important milestone achieved by Elmont srl! Following the patent for remote data exchange for our laminar flow hoods, starting from 21/06/2024, Elmont srl is the first European manufacturer of vertical laminar flow hoods as an In Vitro Diagnostic Device (i.e. IVD).

With the number IT-MF-000042382, Elmont srl is registered as a Manufacturer of IVD in the Medical Devices Database (EUDAMED). This database, introduced by EU Regulations 2017/745 (MDR) and 2017/746 (IVDR), plays a significant role in the new direction of Medical Devices and IVD.

Simultaneously with the European Registration, we have fulfilled all obligations required by Italian regulations and registered the models of Biohazard vertical laminar flow hoods listed in the table below with the Italian Ministry of Health as In Vitro Diagnostic Devices (IVD). Below, you can find the Italian registry numbers of the medical devices registered according to regulation 2017/746 IVDR – the table can be freely consulted on the Italian Ministry of Health's website (Medical Devices Registry).

The new models of vertical laminar flow hoods, certified as IVD, represent a parallel product line to our already established 'classic' line: Bio Activa / Bio Activa VE / Bio Activa ONE.

Elmont stands out as the first and only company to offer vertical laminar flow hoods with IVD certification, regularly registered with the Italian Ministry of Health. In analysis laboratories, both public and private, the use of IVD-certified products is essential!

Elmont is determined to continue on the path that will allow us to obtain new certifications, and we are close to achieving further milestones in the technological development of our products. 

Quality, safety, and operator satisfaction are our priorities, and for this reason, we constantly invest in technical improvements and the qualification of our hoods.