PRÜFSTELLE FÜR MEDIZINPRODUKTE GRAZ
Kopernikusgasse 24/1
8010 GRAZ
Country : Austria
Phone : +43/316.873-7397
Fax : +43/316.873-4412
Email : norbert.leitgeb@tugraz.at
Website : Prüfstelle für Medizinprodukte Graz (Austria)
Notified Body number : 0636
Medical Device Directive Accreditation
MD 0102 – Non-active devices for injection, infusion, transfusion and dialysis
MD 0103 – Non-active orthopaedic and rehabilitation devices
MD 0104 – Non-active medical devices with measuring function
MD 0105 – Non-active ophthalmologic devices
MD 0106 – Non-active instruments
MD 1101 – Devices for extra-corporal circulation, infusion and haemopheresis
MD 1102 – Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
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 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 (extracorporal) shock-wave therapy (lithotripsy)
Horizontal Technical Competence
MDS 7004 – Medical devices referencing the Directive 2006/42/EC on machinery
MDS 7006 – Medical devices in sterile condition
MDS 7007 – Medical devices utilising micromechanics
ANNEXES
Annex III
Annex IV
Annex II
Annex V
Annex VI