Hi everyone,

I'm facing an ongoing issue with Amazon incorrectly classifying our product—a Suture Practice Kit—as containing surgical clamps, medical forceps, and hypodermic needles, leading to its removal from Amazon.co.uk.

Key Points: The tools in the kit are non-sterile, non-medical-grade, and explicitly intended for educational practice only on synthetic models. They are unsuitable for use on humans or animals, as clearly stated in our packaging and instructions disclaimers. However, Amazon’s automated system keeps flagging our product as prohibited surgical tools. This misclassification is based on appearance, not function. We've tried to explain that other products resembling prohibited items are allowed on Amazon because they serve a different purpose than the real item. Our educational tools fall into the same category—they resemble surgical tools but are clearly labeled and designed (different size, materials, etc.) for training only.

The Official organ that regulates medical devices in the UK agreed with us in our email correspondence and clearly stated that our product is not a medical device because it doesn't meet the requirements to be considered one (medical devices either treat, prevent, or diagnose a disease).

We've appealed multiple times but keep receiving the same automated response. I’m seeking a solution that includes manual review by Amazon staff, as the automated process isn’t identifying the true nature of the product.

Any advice or support would be appreciated!

I have had my listing blocked for the reason of it being a class 2a medical device. My question is what documents do I need to submit on my appeal to have the ASIN reinstated as there are other sellers listing the exact same product for over 12 months and in regards to these amazon say no violation has been identified. My product is the same as theirs from the same brand and supplier. please help

We have had this recently, Amazon decided some of our products are medical devices when they are not. They have asked for certain documentation which I cannot provide as they are not medical devices so do not have the documentation that Amazon require. Unfortunately, most non medical devices do not come with documentation stating this is not a medical device.

Telling Amazon that this is not a medical device over and over and over and over and over again doesn't work, you just get the same copy and paste response asking for the non existent documentation. We have deleted and closed the affected listings.