Certificates

  • CE 1015

    CE 1015

    It shows the suitability of the covered products according to Medical Device Directive 93/42/EEC. It is given by the notified body which is approved by the European Union. Novitas has got CE 1015 mark for its production of sterile products in the first aid kits.

  • DIN 13164

    DIN 13164

    DIN 13164 Quality Standard is given by DIN (Deutsches Institut für Normung e.V.) for the First Aid Contents. This norm is accepted even by all the European countries.

    

Novitas produces the first-aid kit contents according to quality standard DIN 13164.

  • ISO 9001-2008

    ISO 9001-2008

    ISO 9001:2008 quality standards mean that; there are a set of procedures that cover all key processes in the business; monitoring processes to ensure they are effective; keeping adequate records; checking output for defects, with appropriate and corrective action where necessary; regularly reviewing individual processes and the quality system itself for effectiveness; and facilitating continual improvement.

  • ISO 13485-2003

    ISO 13485-2003

    ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services.

  • ECE 27R

    ECE 27R

    Manufacturers in the automotive industry should have international quality certificates such as E or ECE, to be in the international markets.

    RDW is one of the most reputable notified bodies that provide this type of quality approvals and certifications.

    
Novitas has been manufacturing warning triangle with E 4 mark which was provided from RDW organizations. (Approval number: E4-27R-032 746)

  • ECE 44-04

    ECE 44-04

    According to new changes in Turkish Road Traffic Regulation on 1st June 2010, it is obligated to use child car seats in Turkey.

    ECE regulation 44/03 or 44/04 means that child restraint system has to be tested and approved by a notified body.

    PROjunior child car booster seat are tested and approved to the current Child Safety Standard ECE R 44/04.

    PROjunior approval number is E20 44R-04 2655