社区 发现 Amazon Amazon美国健康类目产品上架求助：刚...
Amazon美国健康类目产品上架求助：刚上架几分钟就被亚马逊扫到被下架并收到警告信，但是类目下同样的产品有几个中国卖家在卖，这些卖家是如何能实现上架的？
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Amazon美国站尝试上架一款健康类产品，刚上架几分钟就被亚马逊扫到被下架并收到下面的警告信。但是类目下同样的产品 (ASIN B0D674JM8N) 有几个中国卖家在卖，而且链接看上去比较稳定（2-3个月）。我的理解是这类产品除非能证明不是professional-use only medical device, 那基本是无法通过亚马逊审核上架的。请高人指点：这些卖家是如何能实现上架的？
This product has been identified as an intra-oral device used to treat snoring and or sleep apnea, which is a professional-use only medical device. Per Amazon policy, professional-use only medical devices may only be sold to appropriately licensed healthcare customers who have Amazon Business accounts. If you believe this determination was made in error and your product is not a professional-use only medical device, please contact Seller or Vendor Support and provide (1) photos of all sides of the product packaging, (2) photos of the instructions for use included with the product, and (3) the 510(k) number issued by the U.S. Food & Drug Administration (FDA) for this product. If the name of the product provided on the product packaging, instructions for use, or ASIN detail page does not match the device name provided on the 510(k), please also provide, with the information noted above, (1) the device manufacturer’s FDA establishment registration number OR owner/operator number, (2) the device name as it appears in the manufacturer’s device listing, and (3) a purchase order, invoice OR letter (written in English) from the manufacturer confirming that the device was purchased from the manufacturer. For more information, please see our Medical Devices and Accessories Help Page (https://sellercentral.amazon.c ... 164330) and the following FDA guidance: https://www.fda.gov/medicaldev ... 2.htm https://www.fda.gov/MedicalDev ... t.htm
This product has been identified as an intra-oral device used to treat snoring and or sleep apnea, which is a professional-use only medical device. Per Amazon policy, professional-use only medical devices may only be sold to appropriately licensed healthcare customers who have Amazon Business accounts. If you believe this determination was made in error and your product is not a professional-use only medical device, please contact Seller or Vendor Support and provide (1) photos of all sides of the product packaging, (2) photos of the instructions for use included with the product, and (3) the 510(k) number issued by the U.S. Food & Drug Administration (FDA) for this product. If the name of the product provided on the product packaging, instructions for use, or ASIN detail page does not match the device name provided on the 510(k), please also provide, with the information noted above, (1) the device manufacturer’s FDA establishment registration number OR owner/operator number, (2) the device name as it appears in the manufacturer’s device listing, and (3) a purchase order, invoice OR letter (written in English) from the manufacturer confirming that the device was purchased from the manufacturer. For more information, please see our Medical Devices and Accessories Help Page (https://sellercentral.amazon.c ... 164330) and the following FDA guidance: https://www.fda.gov/medicaldev ... 2.htm https://www.fda.gov/MedicalDev ... t.htm
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