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Seller_saUcIEDMxVBqB

Restricted Product Policy Violations - Canada, Classified as Class II Medical Device and Request for Medical Device License (MDL)

Our product has been guided by Health Canada to be class I Medical Device, but Amazon Canada continues to automatically flagging it to be class II.

Our product meets all definitions of class I and I have the appropriate Medical Device Establishment License (MDEL) to sell this device.

ASIN: B0DRZXYHKZ

Despite our numerous attempts to resolve this, Amazon delisted our product.

Once again we kindly request that this case be escalated to ensure a timely response.

@Emet_Amazon @Christine_Amazon @Ricardo_Amazon @Atlas_Amazon @Ricardo_Amazon @Levi_Dylan_Amazon @Daryl_Amazon @Jurgen_Amazon

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6 replies
Tags:Product compliance, Regulations and standards
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Seller_saUcIEDMxVBqB

Restricted Product Policy Violations - Canada, Classified as Class II Medical Device and Request for Medical Device License (MDL)

Our product has been guided by Health Canada to be class I Medical Device, but Amazon Canada continues to automatically flagging it to be class II.

Our product meets all definitions of class I and I have the appropriate Medical Device Establishment License (MDEL) to sell this device.

ASIN: B0DRZXYHKZ

Despite our numerous attempts to resolve this, Amazon delisted our product.

Once again we kindly request that this case be escalated to ensure a timely response.

@Emet_Amazon @Christine_Amazon @Ricardo_Amazon @Atlas_Amazon @Ricardo_Amazon @Levi_Dylan_Amazon @Daryl_Amazon @Jurgen_Amazon

Tags:Product compliance, Regulations and standards
00
58 views
6 replies
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6 replies
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Seller_saUcIEDMxVBqB

@Ricardo_Amazoncan you help with this? the case ID is 16976631191

00
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Seller_RBv4mPFm7TIqv

We couldn't get it resolved so we contacted a SPN agency called Quality Smart Solutions to help resolve deslisting issues (and they helped with a 510K registration for the US market).

00
user profile
Ricardo_Amazon

Hello @Seller_saUcIEDMxVBqB,

Ricardo from Amazon here.

I've sent this request to our Escalations team. Once I receive a response I will be letting you know.

00
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Seller_saUcIEDMxVBqB

Restricted Product Policy Violations - Canada, Classified as Class II Medical Device and Request for Medical Device License (MDL)

Our product has been guided by Health Canada to be class I Medical Device, but Amazon Canada continues to automatically flagging it to be class II.

Our product meets all definitions of class I and I have the appropriate Medical Device Establishment License (MDEL) to sell this device.

ASIN: B0DRZXYHKZ

Despite our numerous attempts to resolve this, Amazon delisted our product.

Once again we kindly request that this case be escalated to ensure a timely response.

@Emet_Amazon @Christine_Amazon @Ricardo_Amazon @Atlas_Amazon @Ricardo_Amazon @Levi_Dylan_Amazon @Daryl_Amazon @Jurgen_Amazon

58 views
6 replies
Tags:Product compliance, Regulations and standards
00
Reply
user profile
Seller_saUcIEDMxVBqB

Restricted Product Policy Violations - Canada, Classified as Class II Medical Device and Request for Medical Device License (MDL)

Our product has been guided by Health Canada to be class I Medical Device, but Amazon Canada continues to automatically flagging it to be class II.

Our product meets all definitions of class I and I have the appropriate Medical Device Establishment License (MDEL) to sell this device.

ASIN: B0DRZXYHKZ

Despite our numerous attempts to resolve this, Amazon delisted our product.

Once again we kindly request that this case be escalated to ensure a timely response.

@Emet_Amazon @Christine_Amazon @Ricardo_Amazon @Atlas_Amazon @Ricardo_Amazon @Levi_Dylan_Amazon @Daryl_Amazon @Jurgen_Amazon

Tags:Product compliance, Regulations and standards
00
58 views
6 replies
Reply
user profile

Restricted Product Policy Violations - Canada, Classified as Class II Medical Device and Request for Medical Device License (MDL)

by Seller_saUcIEDMxVBqB

Our product has been guided by Health Canada to be class I Medical Device, but Amazon Canada continues to automatically flagging it to be class II.

Our product meets all definitions of class I and I have the appropriate Medical Device Establishment License (MDEL) to sell this device.

ASIN: B0DRZXYHKZ

Despite our numerous attempts to resolve this, Amazon delisted our product.

Once again we kindly request that this case be escalated to ensure a timely response.

@Emet_Amazon @Christine_Amazon @Ricardo_Amazon @Atlas_Amazon @Ricardo_Amazon @Levi_Dylan_Amazon @Daryl_Amazon @Jurgen_Amazon

Tags:Product compliance, Regulations and standards
00
58 views
6 replies
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Seller_saUcIEDMxVBqB

@Ricardo_Amazoncan you help with this? the case ID is 16976631191

00
user profile
Seller_RBv4mPFm7TIqv

We couldn't get it resolved so we contacted a SPN agency called Quality Smart Solutions to help resolve deslisting issues (and they helped with a 510K registration for the US market).

00
user profile
Ricardo_Amazon

Hello @Seller_saUcIEDMxVBqB,

Ricardo from Amazon here.

I've sent this request to our Escalations team. Once I receive a response I will be letting you know.

00
Follow this discussion to be notified of new activity
user profile
Seller_saUcIEDMxVBqB

@Ricardo_Amazoncan you help with this? the case ID is 16976631191

00
user profile
Seller_saUcIEDMxVBqB

@Ricardo_Amazoncan you help with this? the case ID is 16976631191

00
Reply
user profile
Seller_RBv4mPFm7TIqv

We couldn't get it resolved so we contacted a SPN agency called Quality Smart Solutions to help resolve deslisting issues (and they helped with a 510K registration for the US market).

00
user profile
Seller_RBv4mPFm7TIqv

We couldn't get it resolved so we contacted a SPN agency called Quality Smart Solutions to help resolve deslisting issues (and they helped with a 510K registration for the US market).

00
Reply
user profile
Ricardo_Amazon

Hello @Seller_saUcIEDMxVBqB,

Ricardo from Amazon here.

I've sent this request to our Escalations team. Once I receive a response I will be letting you know.

00
user profile
Ricardo_Amazon

Hello @Seller_saUcIEDMxVBqB,

Ricardo from Amazon here.

I've sent this request to our Escalations team. Once I receive a response I will be letting you know.

00
Reply
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