Reliability is important for us

We can guarantee the quality of our products, as the processes of design, production and quality control all conform to the harmonized laws set by the European Union. BIONIKA Medline Kft. is operated according to the MSZ EN ISO 9001 and the MSZ EN ISO 13485 quality management system. Our products bear the CE mark, which is ensured by NEOEMKI. We provide a long-term warranty for our products. After the insertion of the implant, – reducing the medical risks of the ossification process – we provide a replacement guarantee for the implants that are dropped or fall out, regardless of the causal relationship, within one year of purchase.

ISO 9001-2015 ENG - QT-CERT - 2025.01.24
ISO 13485
CE Certificate
CE Certificate

BIONIKA Manufacturer’s Declaration

BIONIKA Medline Kft. has always paid close attention to quality and reliability during its nearly 30 years of existence. The Bisnode certificate is a proof of our reliability and stability.

BIONIKA has also received a “Triple A” Bisnode qualification every year since 2016.

AAA – Highest Creditworthiness

At the Hungarian market, only 0.63% of companies have the AAA Bisnode rating. The financial risk of establishing a business relationship with these business associations is extremely low – source:

The opinions and satisfaction of our customers and partners is important for our company. Our company has earned the “Consumer Opinion” certificate.

The BIONIKA was honoured with the “Consumer Opinion Gold” certificate in 2017. The certificate can be claimed by businesses of which the Opinion Factor algorithm could not find a negative consumer opinion on the internet. In accordance with this, BIONIKA has been provided with the certificate for 3 years.