Ticket System Ticket Details

Ticket Number [T000359]
Amazon Account Health-Product Policy Compliance.

The Hive Menstrual Cup & Winion Sanitary Napkin need additional documents as requested from Amazon.Below are what amazon required: To move forward with the approval process for your product, submit the following documents: * Product packaging and label images for all menstrual devices you list. o Product images must show all sides of the product packaging. o Product images and detail page content must comply with Amazon's labeling policy for medical devices. * Documentation demonstrating all of the following: FDA Establishment Registration number -- Screenshot; and FDA Device Listing -- Screenshot * Test reports from an ISO 17025 accredited laboratory confirming each product meets the Medical Device Labeling Requirements (21 CFR Part 801) * For menstrual tampons only: In addition to the required documentation above: FDA 510(k) Premarket Notification -- FDA Approval letter

Hi Tang Zhe,

By choosing other category not required additional document. Can you try choose different category to list The Hive Menstrual Cup & Winion Sanitary Napkin. Let us know here if still have difficulties during listing. Thank you.

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