SGS FIMKO OY
P.O. Box 30
Särkiniementie 3
00211 HELSINKI
Country : Finland
Phone : +358 9 696 361
Fax : +358 9 692 5474
Email : sgs.fimko@sgs.com
Notified Body number : 0598
Website : SGS FIMKO OY
Medical Device Accreditation
MD 0101: Non-active devices for anesthesis, emergency and intensive care
MD 0103: Non-active orthopedic and rehabilitation devices
MD 0104: Non-active Devices with measuring function
MD 0106: Non-active instruments
MD 0108: Non-active medical devices for disinfecting, cleaning, rinsing
MD 0202: Non-active orthopedic implants
MD 0401: Non-active dental equipment and instruments
MD 0402: Dental Materials
MD 0403: Dental Implants
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 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
Horizontal Technical Competence
MDS 7004: Medical devices referencing Directive 2006/42/EC on machinery
MDS 7006: Medical devices in sterile condition
ANNEXES
MDD ANNEX II: Full Quality Assurance
MDD ANNEX III: EC-Type Examination
MDD ANNEX IV: EC Verification
MDD ANNEX V: Production Quality Assurance
MDD ANNEX VI: Product Quality Assurance