EUROLyser Diagnostica GmbH

About EUROLyser Diagnostica

EUROLyser Diagnostica GmbH, based in Salzburg, has specialised in near-patient diagnostics (point-of-care testing) for more than 20 years. The company develops and manufactures analysis instruments and test kits for use in medical practices, clinics and emergency departments; product development and manufacturing take place exclusively within the EU. Products include the CUBE series analysers for human medicine as well as the in-house veterinary analyser CUBE-VET; the parameter portfolio includes, for example, tests for measuring beta-hydroxybutyrate (BHB). Distribution is handled worldwide through certified local sales partners, and the company also offers rental of medical devices. Quality assurance is carried out via an internal quality management system in accordance with international standards; suppliers and manufacturing partners are ISO-certified.

Site

Salzburg

Processes

Development and manufacture of point-of-care instruments and test kits, Distribution via certified local sales partners, Rental of medical devices

Certificates

ISO 27001:2022, Internal QM system according to international standards

Industries

Medical technology / In-vitro diagnostics, Point-of-care diagnostics, Veterinary diagnostics

1. 01

   Research and development

2. 02

   Manufacturing (in the EU, with ISO-certified partners)

3. 03

   Quality management

4. 04

   Distribution via certified local partners

5. 05

   Rental of medical devices

Locations

Quality

An internal quality management system describes and governs all relevant processes and responsibilities in accordance with international standards and directives. All suppliers and manufacturing partners are ISO-certified.

History

1. Start of business operations in point-of-care testing; active for more than 20 years

2. 2025

   Certification according to ISO 27001:2022