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Classification

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Guest user Created:   Jul 12, 2021 Last commented:   Jul 13, 2021

Classification

Just a quick question. If I have equipment that generates oxygen for medical applications, and the machine only generates and fills the oxygen tanks, which are then used in hospitals, etc, is the generating equipment a medical device? If so, what would be the classification?

It sounds to me a bit like equipment that is used to manufacture medicines for instance, and in my opinion it should not be classified as a medical device.

Your input will be greatly appreciated. We need to urgently clear this, because my client is importing the equipment to ***, and we need to know what registrations, etc, we need to apply. It is because medical devices are regulated in ***, but we apply more or less the same requirements as the EU.

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

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Kristina Zvonar Brkić Jul 13, 2021

To my understanding of this equipment, equipment that generates oxygen for medical applications is not a medical device. A medical device is the oxygen tank if that oxygen has a medical device purpose and not as medicine.  

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Jul 12, 2021

Jul 13, 2021