Kiwa Meyer A.Ş.

Kiwa Meyer Belgelendirme Hizmetleri A.Ş.
İstanbul Tuzla Organize Sanayi Bölgesi (İtosb) 9.  Cadde No: 15 Tepeören Mevkii Ankara Asfaltı Tuzla
Country : Turkey
Phone : + 90 216 593 25 75
Fax : + 90 216 593 25 74
Email :;
Notified Body number : 1984
Website : Kiwa Meyer Belgelendirme Hizmetleri A.Ş.

Medical Device Accreditation
MD 0101: Non-active devices for anesthesis, emergency and intensive care
MD 0102: Non-active devices for injection, infusion, transfusion and dialysis
MD 0103: Non-active orthopedic and rehabilitation devices
MD 0104: Non-active Devices with measuring function
MD 0105: Non-active ophthalmologic devices
MD 0106: Non-active instruments
MD 0107: Contraceptive medical devices
MD 0108: Non-active medical devices for disinfecting, cleaning, rinsing
MD 0109: Non-active devices for in vitro fertilsation and assisted reproductive technologies
MD 0201: Non-active cardiovascular implants
MD 0202: Non-active orthopedic implants
MD 0203: Non-active functional implants
MD 0204: Non-active soft tissue implants
MD 0301: Bandages and wound dressings
MD 0302: Suture material and clamps
MD 0303: Other material for wound care
MD 0401: Non-active dental equipment and instruments
MD 0402: Dental Materials
MD 0403: Dental Implants
MD 1101: Devices for exracorporeal circulation, infusion and hemopheresis
MD 1102: Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anesthesia
MD 1103: Devices for stimulation or inhibition
MD 1104: Active surgical devices
MD 1105: Active ophthalmologic devices
MD 1106: Active dental devices
MD 1107: Active devices for disinfection and sterilisation
MD 1108: Active rehabilitation Devices and active prostheses
MD 1109: Active devices for patient positioning and transport
MD 1110: Active devices for in-vitro fertillisation and assisted reproductive therapy
MD 1111: Software
MD 1201: Imaging devices utilising ionizing radiation
MD 1202: Imaging devices utilising non-ionizing radiation
MD 1301: Monitoring devices of non-vital physiological parameters
MD 1302: Monitoring devices of vital physiological parameters
MD 1401: Devices utilising ionizing radiation
MD 1402: Devices utilising non-ionizing radiation
MD 1403: Devices for hyperthermia / hypothermia
MD 1404: Devices for (extracorporeal) shock-wave therapy (lithripsy)

Horizontal Technical Competence
MDS 7001: Medical devices incorporating medicinal substances
MDS 7003: Medical devices incorporation derivatives of human blood
MDS 7004: Medical devices referencing Directive 2006/42/EC on machinery
MDS 7006: Medical devices in sterile condition
MDS 7007: Medical devices utilizing micromechanics
MDS 7008: Medical devices utilising nanomaterials
MDS 7009: Medical devices utilising biological active coatings and/or materials being wholly or mainly absorbed

MDD ANNEX II: Full Quality Assurance
MDD ANNEX V: Production Quality Assurance
MDD ANNEX VI: Product Quality Assurance