社區(qū) 發(fā)現(xiàn) Amazon Amazon美國健康類目產(chǎn)品上架求助：剛...
Amazon美國健康類目產(chǎn)品上架求助：剛上架幾分鐘就被亞馬遜掃到被下架并收到警告信，但是類目下同樣的產(chǎn)品有幾個中國賣家在賣，這些賣家是如何能實現(xiàn)上架的？
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Amazon美國站嘗試上架一款健康類產(chǎn)品，剛上架幾分鐘就被亞馬遜掃到被下架并收到下面的警告信。但是類目下同樣的產(chǎn)品 (ASIN B0D674JM8N) 有幾個中國賣家在賣，而且鏈接看上去比較穩(wěn)定（2-3個月）。我的理解是這類產(chǎn)品除非能證明不是professional-use only medical device, 那基本是無法通過亞馬遜審核上架的。請高人指點：這些賣家是如何能實現(xiàn)上架的？?
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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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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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