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Home CE-Marking Classification of medical devices (which risk class is my medical device?)

Risk classes PDF Print E-mail

Please note that neither EU-rules nor national legislation carry out such a classification of medical devices because, in each particular case, a classification has to be conducted with reference to the intended use.

  

 

Class I

 

Class IIa

 

Class IIb

 

Class III

· Medical instruments

· Crutches

· Wheel chair

· Surgical beds

· Bandaging

 

· Dental filler

· Diagnostic ultrasonic

  devices

· Hearing aids

· Contact lenses

· Tooth crowns

· Muscle and nerve

  stimulation

· Anasthetic devices

· Respiration devices

· X-ray

· Blood bags

· Defibrillator

· Dialysis devices

· Condoms

· Contact lense cleaner

· Dental implants

· Heart catheter

· Endoprothesis

· Coronary stents

· Absorbable surgical

  suture

· Breast implants

· Heart valves


 

 
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