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Risk Class III
 

Device Description

Anaesthesia machine
Anaesthesia vaporiser
Apnea monitor
Blood warmer
Bone cement
Brachytherapy device
Cardiac output unit, direct fick
Cardiotocograph
Condom
Contact lens care solution
Diagnostic X-ray equipment
Dialysate delivery system
Dressings for chronic ulcerated wounds
Dressings for severe burns
Electrocautery equipment
Electroconvulsive therapy equipment
External defibrillator
External pacemaker
Heart-lung bypass equipment
Hemodialysis concentrates
Hemodialysis equipment
Hemodialyzer
Hip implant
Hyperbaric chamber
Hyperthermia system
Implantable staple
Infant incubator
Infusion port
Infusion pump
Insulin pen
Intensive care cardiac monitor
Intra-ocular lenses
Linear accelerator
Lithotriptor
Lung ventilator
Maxillo-facial implant
Non-absorbable suture
Pressure regulator for medical gases
Prosthetic joint replacement
RF electrosurgical generator
RF lesion generator
Surgical laser
Therapeutic cyclotron
Therapeutic X-ray equipment
Urethral stent
Warming blanket


Remarks:
1. The above examples of medical devices are for reference only.
2. The actual classification of a particular device must be considered individually, taking account of its design and use intended by the manufacturer.
3. Where a medical device has features that place it into more than one class, conformity assessment should be based on the highest class indicated.
 
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Medical Device Control Office
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image 2005 copyright logo | Important notices Last revision date: 15 February 2008