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Ticket Number [T000359]
30-Apr-2021 05:54pm
TAN TANG ZHE
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
10-May-2021 02:39pm
AXIS SUPPORT - Elizabeth
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.
11-Sep-2021 03:22pm
AXIS SUPPORT
Hi,
Thank you for connecting with the Axis Support Team.
We have observed this ticket has been well resolved, as a result, we require you to close this ticket. If the ticket did not close within 24-48 hours from the date of this ticket send out, the system will automatically close it on-behalf of you.
I hope that our service has been of assistance to you.
If you require further assistance now, or in the future please do not hesitate to file a new ticket through the Axis system.
Thanks!
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