Medical Device Directive

MEDICAL DEVICES

Istituto Masini is a body notified by European Commission to operate (ref. All.I, II, III, IV, V and VI Leg. Dec. 46/1997) according to several type of devices subject to directive 93/42/EC.

In the framework of these authorizations, Istituto Masini may perform all activities assigned to notified body, necessary to check and issue the documentation in compliance with “essential safety requirements” of medical devices and focused to allow the manufacturers set the “EC branding” on products in compliance with standard 93/42/EEC and following integrations and modifications.

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