1984

Kiwa Belgelendirme Hizmetleri A.Ş.

Türkiye · Istanbul Withdrawn

www.kiwa.com.tr

Designations

MDR Medical devices · Regulation (EU) 2017/745 Withdrawn

Conformity assessment annexesAnnex V, Annex VI, Annex II

Designated since2011-04-27

Full scope text from the register

Annexes

Annex V, Annex VI, Annex II

Procedures

Product quality assurance, EC declaration of conformity (full quality assurance system), Full quality assurance system, EC declaration of conformity (production quality assurance), EC declaration of conformity (product quality assurance), Production quality assurance

Products

*MD 0203 - Non-active functional implants
*MD 0401 - Non-active dental equipment and instruments
*MD 0105 - Non-active ophthalmologic devices
*MD 0101 - Non-active devices for anaesthesia, emergency and intensive care
*MD 0400 - Non-active dental devices and accessories
*MD 0106 - Non-active instruments
*MD 1110 - Active devices for in vitro fertilisation (IVF) and assisted reproductive therapy (ART)
*MD 1403 - Devices for hyperthermia / hypothermia
*MD 0204 - Non-active soft tissue implants
*MD 0103 - Non-active orthopaedic and rehabilitation devices
*MD 1107 - Active devices for disinfection and sterilisation
*MD 0108 - Non-active medical devices for disinfecting, cleaning, rinsing
*MD 1101 - Devices for extra-corporal circulation, infusion and haemopheresis
*MD 1108 - Active rehabilitation devices and active prostheses
*MD 0100 - General non-active, non-implantable medical devices
*MD 1102 - Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
*MD 0107 - Contraceptive medical devices
*MD 1106 - Active dental devices
*MD 0109 - Non-active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART)
*MD 1200 - Devices for imaging
*MD 1109 - Active devices for patient positioning and transport
*MD 1400 - Devices for radiation therapy and thermo therapy
*MD 1401 - Devices utilising ionizing radiation
*MD 0102 - Non-active devices for injection, infusion, transfusion and dialysis
*MD 1402 - Devices utilising non-ionizing radiation
*MD 1202 - Imaging devices utilising non-ionizing radiation
*MD 0200 - Non-active implants
*MD 1201 - Imaging devices utilising ionizing radiation
*MD 1302 - Monitoring devices of vital physiological parameters
*MD 0301 - Bandages and wound dressings
*MD 0104 - Non-active medical devices with measuring function
*MD 1103 - Devices for stimulation or inhibition
*MD 0201 - Non-active cardiovascular implants
*MD 0403 - Dental implants
*MD 1104 - Active surgical devices
*MD 1300 - Monitoring devices
*MD 0300 - Devices for wound care
*MD 1111 - Software
*MD 0302 - Suture material and clamps
*MD 0303 - Other medical devices for wound care
*MD 1100 - General active medical devices
*MD 0202 - Non-active orthopaedic implants
*MD 1105 - Active ophthalmologic devices
*MD 1301 - Monitoring devices of non-vital physiological parameters
*MD 1404 - Devices for (extracorporal) shock-wave therapy (lithotripsy)
*MD 0402 - Dental materials