Certificate scopes

• EN ISO 13485
  

  Design, production, sales and servicing of medical devices for hydrotherapy, physical therapy, physical rehabilitation, tables for rehabilitation treatments, massage tables, traction tables, tables for verticalization, hoists for the transfer of disabled persons, devices for heating treatment masses, treatment furniture, medical supply units (panel system with gas installations), ophthalmic boards.
  Sales and servicing of ESWL and ESWT cameras, devices for EEG and EMG, magnetic stimulators, devices for urodynamics, medical lasers, endoscopes, implants and implantable materials, integrated operating rooms, surgical lights, operating tables, devices for electrotherapy, physiotherapy equipment, neuro-rehabilitation devices, devices for cardiology and cardiac rehabilitation, lasers for rehabilitation, equipment for Neurac therapy, kinesitherapy devices, devices for diagnosis and movement analysis, patient care systems, cryogenic and hyperbaric chambers.

• MDR Ann. IX, Chapt I
  

  Class IIa:
  Z120614 - INFRARED/ULTRAVIOLET LIGHTS
  Z120690 - VARIOUS PHYSIOTHERAPY AND REHABILITATION INSTRUMENTS
  Z120618 - FULL BODY WHIRLPOOL BATHS

  Class IIb:
  Z120309 - MEDICAL/MEDICINAL GAS SYSTEMS AND RELATIVE
  ACCESSORIES