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Incorrect Classification of Educational Product as Medical Device
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!
0 replies
Sarah_Amzn
Hello @Seller_Jm0nfWxLU8XyP,
Thank you for posting on Forums!
I'm Sarah with Amazon.
Have you tried to reach out to Seller Support and request more details? If yes, could you please share the case ID?
Kind regards,
Sarah.
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