Certificate No. I 60082343

Certificate Holder: Digiterm Kft.

Ipar út 7.
3200 Gyöngyös
Hungary
Certificate Number: I 60082343
Order Number: 93333483
Certified Product: Chair (Therapy chair)

Model Designation:
COMFORT-4 Plus

Fulfilled Standards: Richtlinie 93/42/EWG
EN 60601-1:2006+A11
EN 60601-2-52:2010
EN 60601-1-2:2007

The standard(s) listed here reflect the status at the time of the release of this certificate.
Date of Issue: December 28, 2012
Certificate Type: GM-Mark Approval

GM-Mark stands for safety and quality of medical products. With this mark manufacturers proof that they go beyond the legal necessary requirements to guarantee the safety and quality of their products.

For this voluntary testing, TÜV Rheinland checks the product as well as the technical documentation. In addition, TÜV Rheinland professionals conduct periodic surveillance audits of the manufacturing sites in order to ensure consistent quality of production.

For the medical product marking following criteria have to be fulfilled: 

  • Legal requirements: 
    • Successfully passed conformity assessment procedure according to the applicable medical product directive 
    • Medical products – except class I – need a valid certificate of a notified body 
  • Additional requirements:
    • Further product tests according to the appropriate harmonized standards. If standards do not exist, national requirements compliant with the requirements of the medical product directive and discussed with the manufacturer may be applied. 
    • Audit of manufacturing site and periodic surveillance audits (follow-up). 
    • Checking the technical documentation.

The medical product certificate verifies the product’s conformity with the mentioned test specifications.