August

-Schanz-Straße 21, 60433 Frankfurt am Main,

Tel. +49 (0) 69 95427-300, medical.devices@dqs-med.de

410.90.en

Version 1.0

CERTIFICATE

This is to certify that the company

RAFI Hungaria Kft.

Szolnoki út 35

H 5400 Mezötúr

Hungary

has implemented and maintains a Quality Management System.

Scope:

Production of electromechanical components, data entry systems and electronic assemblies for

medical devices.

Through an audit, documented in a report, performed by DQS Medizinprodukte GmbH, it was

verified that the management system fulfills the requirements of the following standard:

DIN EN ISO 13485 : 2016 + AC : 2017-07

EN ISO 13485 : 2016 + AC : 2016

ISO 13485 : 2016

Certificate registration no.

Certificate unique ID

Effective date

Expiry date

Frankfurt am Main

542879 MP2016

170775810

2021-12-22

2024-12-21

2021-12-18

DQS Medizinprodukte GmbH

Sigrid Uhlemann

Managing Director

Dr. Thomas Feldmann

Head of Certification Body