Nasal Saline Solution for Irrigation purpose classification

Balamurugan B

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#1
Hello,

I would like to register Saline Nasal Kit under EU MDR. The device already registered as Class I as per MDD. While during our reclassification, We confirmed that the device comes under class IIa category as per Rule 21.

The device contain a bottle and salt substances. The bottle contains a distilled water and the salt substances are mixed with the distilled water, after mixing the solution flows through the Nasal cavity with the help of Bottle to achieve the intended use. The bottle is a single patient Re use device. Also I would like to sell the salt substances separately to refill. In this case Do I need to classify both bottle and substance separately or single classification is enought?

Share your thoughts,

Best.
 
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