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Risk Class II
 

Device Description

Anaesthesia breathing circuit
Angioscope
Biopsy needle kit
Choledochoscope
Contact lenses
Cryosurgery equipment
Dental alloys
Dental aspirator tip
Dental filling materials
Diagnostic ultrasound scanner
Disinfectant (for medical devices)
Doppler blood flowmeter
Electrical acupuncture
Electrocardiograph (ECG)
Electroencephalograph (EEG)
Electronic sphygmomanometer
Electronic stethoscope
Electronic thermometer
Enteral feeding pump tube
Evoked response stimulator
Feeding pump
Gamma ray camera
Gastroscope
Hearing aids
Infusion cannula
Interferential treatment unit
Intubation set
Iontophoresis unit
Low level laser therapy unit (soft laser)
Magnetic resonance imaging (MRI) equipment
Needle of syringe
Needle used for suturing
Non-invasive bone growth stimulator
Ophthalmic tonometer
Orthodontic wire
Phototherapy lamp
Positron emission tomography equipment
Powered dental hand pieces
Powered dermatome
Pulmonary function analyzer
Sigmoidoscope
Single photon emission computer tomography equipment
Single-use scalpel
Steam sterilizer (autoclave)
Stress exercise monitoring system
Suction catheter
Suction equipment
Surgical gloves
Syringe for infusion pump
Tracheal tube
Transcutaneous electrical neuromuscular stimulator (TENS)
Tubing for use with infusion pumps
Tympanic thermometer
Ultrasonic bone absorptiometer
Ultrasonic fetal heart detector
Ultrasound diathermy (for physiotherapy)
Urinary catheter


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: 26 May 2009