SP Sveriges Tekniska Forskningsinstitut AB/ SP Technical Research Institute of Sweden
Box 857
501 15 BORAS
Country : Sweden
Phone : +46 (0) 10 516 50 00
Fax : +46 (0) 33 13 55 02
Email : info@sp.se
Notified Body number : 0402
Website : SP Sveriges Tekniska Forskningsinstitut AB/ SP Technical Research Institute of Sweden
Medical Device Accreditation
MD 0101: Non-active devices for anesthesis, emergency and intensive care
MD 0104: Non-active Devices with measuring function
MD 0106: Non-active instruments
MD 0203: Non-active functional implants
MD 0401: Non-active dental equipment and instruments
MD 0403: Dental Implants
MD 1102: Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anesthesia
MD 1106: Active dental devices
MD 1111: Software
MD 1201: Imaging devices utilising ionizing radiation
MD 1301: Monitoring devices of non-vital physiological parameters
MD 1302: Monitoring devices of vital physiological parameters
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 V: Production Quality Assurance
MDD ANNEX VI: Product Quality Assurance