Amethyst Biomat Approved as Health Canada Class 2 Medical Device

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Amethyst Biomat Approved as Health Canada Class 2 Medical Device

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Richway and Fuji Bio announced that the Amethyst Biomat has been approved by Health Canada as a Class 2 Medical Device.  This is good news for Canadians as it means that the Amethyst Biomat (Mini, Professional, Single, Queen and King models) are exempt from duty as it crosses the border.

Local provincial/territorial and federal taxes and brokerage fees will still apply.

What is a Class II Medical Device?

From the Government of Canada website:

The term “medical device” covers a wide range of products used in the treatment, mitigation, diagnosis or prevention of a disease or abnormal physical condition. Some examples include pacemakers, artificial heart valves, hip implants, synthetic skin, medical laboratory diagnostic instruments, test kits for diagnosis and contraceptive devices. Medical devices are categorized into four classes based on the level of risk associated with their use. Class I devices present the lowest potential risk (e.g. thermometers) and Class IV devices present the greatest potential risk (e.g. pacemakers).

To find the Device information for the Biomat, follow this link on the Government of Canada’s website:

https://health-products.canada.ca/mdall-limh/index-eng.jsp

then:

  1. Go to Active License Search
  2. Search by Device Name
  3. Search Criterion: “Biomat”
  4. Click the Search button

If you have any questions about the Biomat or any of Richway’s products, please contact us!

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