Lomina Group

We are a strictly Czech-Swiss company focusing on technological advancement, development, manufacture and distribution of a wide range of IVD assays, sequencing equipment, analysers and supportive medical equipment.

Our main development centre is in the Czech Republic (EU), which is also where our products are manufactured on production lines.

Our two main divisions are LOMINA AG and LOMINA Superbio a.s., during which time LOMINA Superbio focuses on development and manufacture of in vitro diagnostic medical devices (IVD).

Lomina Group has been established in 2007 in Switzerland as an A.G. LOMINA AG is also registered as Organizational Unit in the Czech Republic. Subsidiary LOMINA SUPERBIO a.s. was established in August 2018 in the Czech Republic.

Our companies are completely independent. 100% of shareholders are European individuals and LOMINA is not anyhow depending on any out of EU entity. We don’t use any offshores and fully tax in EFTA (EU+Switzerland).

Our mission

LOMINA AG group is committed to provide high-quality diagnostic products and services to meet the global healthcare needs and to empower patients to make a critical decision about their health. A significant aim is to assist Health Care Professionals with their challenging world worldwide.

Corporate culture

LOMINA AG group is combining resources from nearly all continents in order to develop and deliver innovative diagnostic tools to our customers. We are a responsible player that is looking at all aspects of the environment . Our core values define what we stand for, how we conduct ourselves, and how we interact with colleagues, customers, other partners. Our core values are:

Quality

We believe that quality is not only a must but it is a key to success in the medical field. Our organizational culture nurtures self-discipline and continuous improvement trough Total Quality Management procedures and trough both, joint and an individual effort of the entire organization.

Teamwork

We are achieving common goals through an open and straight forward communication. We show concerns for others and we are supportive of each other’s efforts.

Result oriented

We are constantly delivering required business results, meeting deadlines and productivity and performance standards.

Integrity

We are running business with the highest standards of professional behavior and ethics. We are transparent, honest, ethical and fair in all of our interactions.

Agility

We are responding rapidly to changes in the internal and external world.
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Portfolio

Main portfolio is composed of following products:

Diagnostic assays

We offer more than 500 types of IVD assay, including assays for certain very rare diseases. We also offer OEM/OBL production.

IVD devices

We manufacture laboratory in vitro diagnostic devices (IVD), which react to a number of diseases, including infections, tumours, cardiac disease and others.

LOMINA LAB

The Lomina Mobile Laboratory (LOMINA LAB) is a diagnostic kit in the form of a diagnostic IVD case, intended for easy and fast collection and assessment of diagnostic assays, including biochemical values.

Quality management

In December 2020 was LOMINA the first European organization who reached IVD SELFTESTING certificate for its COVID-19 Antibody IVD test.

The group is ISO 13485:2016 certified in a good stand by British Certification Authority NQA-UKAS. Last re-certification took has been done in June 2021.

The company follows also ISO:9001 and we consider official certification to be done during next annual re-audit on 2022.

All LOMINA products are registered at Czech RZPRO and European EUDAMED database.

All LOMINA products are registered In accordance with Directive 98/79/EC of the European Parliament and of the Council and according to:

  • EN ISO 15223-1:2016,
  • EN ISO 14971:2012,
  • EN 13641:2002,
  • EN ISO 18113-1:2011,
  • EN ISO 18113-2:2011,
  • EN 13612:2002,
  • EN ISO 23640:2015.

Certificates

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