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.