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CLASSIFICATION

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Q1.
What is a controlled medical device (Class II)?

What do the terms 'controlled medical device' and 'class II' mean for physiotherapy equipment and other devices?

Medical devices, according to the level of risk to the patient, They are classified into four classes.

  • Class I General medical devices
    Equipment that is considered to pose an extremely low risk to the human body even in the event of a malfunction (e.g. in vitro diagnostic equipment, scalpels, tweezers, X-ray films, etc.).
  • Class II Controlled medical devices
    Items for which the risk to the human body is considered to be relatively low even if a fault occurs (e.g. low-frequency treatment equipment, MRI equipment, electronic endoscopes, gastrointestinal catheters, etc.).
  • Class III Highly controlled medical devices
    Items considered to pose a relatively high risk to the human body in the event of a malfunction (e.g. dialysis machines, artificial bones, artificial respirators, etc.).
  • Class IV Highly controlled medical devices
    Highly invasive to the patient and may directly endanger life in the event of a malfunction (e.g. pacemakers, artificial heart valves, stent grafts, etc.).
    Most of the medical devices sold by Technolink fall under Class II controlled medical devices.

In addition to the above-mentioned classifications of medical devices, there are also "Specified maintenance-controlled medical devices", which require specialist knowledge and skills for maintenance, inspection, repair and other management, and which may have a serious impact on the diagnosis, treatment or prevention of diseases if not properly managed. The catalogue describes them as controlled medical devices and specified maintenance controlled medical devices.

Q2.
What is JMDN code?

It is a code that corresponds to the generic name of the medical device.

  • * Partial excerpt.
  • 11246000 Ultrashort wave therapy equipment
  • 11248000 Ultrasonic treatment equipment
  • 13763000 Electro-acupuncture electro-polar low-frequency treatment equipment
  • 35147000 Infrared radiation therapy equipment
  • 35372000 Low-frequency treatment equipment
  • 70623000 Combination physiotherapy equipment for low-frequency and ultrasound therapies
  • 70986000 Home-use low-frequency treatment equipment
  • 70988000 Home-use ultra-short wave therapy devices
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