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Dear Forum,
I am facing yet another classification issue! I hope that you can help.
With a centrifuge device, if my manufacturer provides a disposable centrifugation unit for the processing of the blood is this classed as a Class IIb device (i.e. a "blood bag"). I was visited by a consultant who says that the whole system is a Class IIb because of the "blood bag" component. Though I do not think that this is the case - I claim that its not a "blood bag", I want to stick with my original Class IIa classification.
Any thoughts on which classification I should stick to?
Thanks.
I am facing yet another classification issue! I hope that you can help.
With a centrifuge device, if my manufacturer provides a disposable centrifugation unit for the processing of the blood is this classed as a Class IIb device (i.e. a "blood bag"). I was visited by a consultant who says that the whole system is a Class IIb because of the "blood bag" component. Though I do not think that this is the case - I claim that its not a "blood bag", I want to stick with my original Class IIa classification.
Any thoughts on which classification I should stick to?
Thanks.