According to the compatibility assessment method chosen by the manufacturer (combining the above mentioned annexes) these activities may concern:
- Laboratory test referring to harmonized rules applied to products
- Assessment and similarities to company quality management systems required by directive 93/42/EC.
Istituto Masini has been authorized by the related ministries to operate on the following categories of medical devices:
- Medical devices for anesthesia and reanimation:
- Defibrillation device
- Transcutaneous monitor pO2/pCO2
- Continuous positive pressure, device for manual breathing
- Lung fan
- Continuous flow anesthesia devices.
Medical devices for cardiac surgery
- Extracorporeal circulation heater/cooler
- Sternotome
- Devices for infusion and transfusion
- Devices for plasmapheresis and blood recovery
Medical devices for cardiology
- System for stress test
- External cardiac stimulator
- Cardio-phone
- Bicycle ergometer
- Intra-aortic balloon pump
- Electrocardiograph
- ECG Holter reader
- Runner
- Polygraph
- Holter recorder
- ECG telemetry unit
Medical devices for general surgery
- Nitrogen protoxide analyzer
- Device for anesthesia
- Ultrasound aspiration device
- Medical surgical aspiration device
- Self-transfusion device
- Electric dermatome
- Diathermocoagulator
- Electro-scalpel
- Photocoagulator
- Surgical light
- Surgical laser
- Operating table
- Thermo-welding device
- Optical fibers
- Invasive devices for surgery
Medical devices for physiotherapy and rehabilitation
- Biofeedback device
- Microwave geothermic device
- Shortwave medical diathermy
- Ultrasounds diathermy device
- Electrotherapy device
- Iontophoresis device
- Therapeutic laser
- Intracerebral / subcortical electro-analgesic stimulator
- Spine electro-analgesic stimulator
- Face stimulator
- Muscle stimulator
- Neurological stimulator
- Neuromuscular stimulator
- Bowel washout devices
Gastro-enterology medical devices
- Endoscope
- Light source
- Gas insufflators
- Rectoscope
- Signoidoscope
- TV system for endoscopy
- Camera for endoscopy techniques
Medical devices for gynecology and obstetrics
- Colposcope
- Laparoscope
- Fetal monitor
- Fetal heart rate detector
Medical devices for chemical analysis
- Cutaneous biliruminometer
- Medical devices for general medicine
- Aerosol device
- Emospeedometer
- Phonendoscope
- Device for oncologic hyperthermia
- Hypothermia device
- Infrared lamp
- Ultra-violet/infrared lamp
- Automatic blood pressure meter
- Direct blood pressure meter
- Reaction times meter
- pH monitor
- Nebulizer
- Pump nutrition device
- Ear oximeter
- Plethysmograph
- Infusion pump
- Sphygmomanometer
- Blood pressure monitoring system
- Stethoscope
- Thermometer
- Body thermoregulation device
- Autoclave
- Sterilizers
- Wound bandages and medication
Medical devices for nephrology and blood analysis
- Deionizer
- Device for peritoneal dialysis
- Device for blood-dialysis
- Device for blood filtration
- Balance bed for dialysis
- Heparin pump
- Blood bags
- Bags for tube feeding and parenteral nutrition
- Dialysis filters and concentrates
Medical devices for neurosurgery
- Stereotaxis system
- Neurosurgical drill
Medical devices for nervous system physiopatological neurology
- Doppler spectral analyzer
- EEG spectral analyser
- Echoencelography device
- Electroencelography device
- Electromyography device
- EEG Holter reader
- Device for the analysis of evoked potential
- Electrotherapy stimulators
- EG telemetry unit
- EMG telemetry unit
Medical devices for dentistry
- Dental chairs and delivery units
- Dental tools
- Reconstruction plants
- Tooth plants
- Cements
Medical devices for ophthalmology
- Peripheral vision analyzer
- Device for ophthalmic diathermy
- Electronystagmograph
- Electrooculograph
- Electoretinograph
- Camera for fluorescence angiography
- Diode laser
- Lens meter
- Slit lamp
- Retinoscopy target
- Ophtalmoscopy
- Ophtalmometer
- Ophtalmic lasers
- Ocular tonometry meter
Medical devices for orthopedics and traumatology
- Orthopaedic saw
- Plaster cast stove
- Orthopaedic drill
- Joints for osteosynthesis
Medical devices for otoralingology
- Audimeter
- Acoustic chamber
- Tympanometry
- Laryngoscope
- Nasoscope
- otoscope
- Otoralingology unit
Medical devices for paediatrics and neonatology
- Device for paediatric phototherapy
- Neonatal incubator
- Transport neonatal incubator
- Apnoea monitor
Medical devices for pneumology and physiopathology
- Bronchoscope
- Oxygen concentrator
- Rhinomanometer
- Spirometer
- Bell spirometer
- Dry spirometer
Medical devices for radiology and nuclear medicine
- Bone densitometer
- Dosimeter
- Thermograph
- Magnetic resonance tomographer
- Devices for diagnostic therapy with ionizing radiations
Medical devices for urology
- Cystoscope
- Urodynamics system
- Uroflowmeter
And also
- Contact lenses
- Devices for contact lenses treatment
- Prophylactics
- Bed-heading bars
- Dropping funnels, droppers, drugs dispensers
- Software for the measurement and monitoring of physiological parameters
