NIVA Certificates
Production according to modern global and European standards
Quality, reliability, responsibility
Our company has aligned its operations with the essential requirements of European directives ISO 9001:2015, ISO 13485:2012, and EC 42:1993, as well as with the standards of national legislation governing the field of medical devices. In this way, we have ensured that the product we bring to market is biocompatible and safe for the end user.
ISO 13485:2016
Certificate number / Date of certification:
M-032 / 2010-05-26
Issue: 14 / 2023-02-14
Valid until: 2025-04-30
26.05.2010.
ISO 9001:2015
Certificate number / Date of certification: Q-1485 / 2010-05-26 Issue: 10 / 2022-06-30 Valid until: 2025-04-30
26.05.2010.
EC MDD-010
EC Certificate
Production Quality Assurance
Directive
93/42/EEC on Medical Devices,
Annex V
Certificate No. MDD-010
26.05.2010.
EC MDD-145
EC Certificate
Production Quality Assurance
Directive
93/42/EEC on Medical Devices,
Annex V
Certificate No. MDD-145
25.05.2021.
IFS HPC V3
Has been found to conform to IFS HPC, VERSION 3 DECEMBER 2022 and other associated normative documents HIGHER LEVEL with a score of 97.24%
18.12.2024.
Production according to modern global and European standards
ISO 9001:2015
Our company has aligned its operations with the essential requirements of European directives.
ISO 13485:2012
In this way, we have ensured that the product we bring to market is biocompatible and safe for the end user.
EC 42:1993
The company NIVA meets all necessary standards and holds all relevant certificates.
Your brand, our mission
The company NIVA offers its customers the opportunity to present the complete product range of our company as a private label, that is, under their own brand name.