EC certificate Phonak. SOLVED

Hello.
I’m from Spain and I purchased a Phonak product in the US. Customs is holding it. They’re asking me to send them:
EC Certificate/Notified Body: No. 38657, issued by GMED (0459)

There are several certificates on the Phonak website, but the one they’re requesting isn’t there. I’ve contacted Sonova AG three times, but they haven’t responded or solved the problem.

I’ve also contacted GMED, but they can’t provide it. They tell me to ask the manufacturer or
However, you will be able to find all existing certificates on the EUDAMED platform. But I haven’t been able to find it there.

If anyone has purchased a product in the US and obtained the necessary EC certificate, or knows where or how to obtain it, please contact me. Thank you.

Wow really, that’s just so stupid, it’s probably easier to have the parcel redirected to a family member or friend in another country and then get them to send to you as a gift or something.

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what product did you purchase? Could you please send the model name of the product?

is this what you need?

Perhaps the link below:

https://fccid.io/KWC

Thanks for your response Tenkan. It’s certainly stupid, but here at Madrid customs, they’re really demanding. The bad thing is that they won’t return the product to the US because they destroy it. But if I can get it returned, I’ll contact you and we’ll talk as friends because I haven’t family member in another country.
Don’t products from the US go through customs in your country?
Greetings from Spain

1 par phonak P90 -13T for my Cros paradise that I use now.

Thanks Hooby but this is the EU Declaration of Conformity they also ask me for that document, but we can find it on the www.phonak.com certificates page, but what is missing is the CE certificate, which is what I am missing and which appears registered within the EU Declaration of Conformity with the number 38657. Thank you for your trouble.

Thanks for responding, but that’s not what I need. I’ll attach a CE certificate like the one I need, but it’s expired and isn’t for the product in question. This is CE certificate 30380, and I need the updated CE certificate No. 38657.
Thanks for your input. Best regards.
QDL-104-5-CE-certificate-30380-rev-12.pdf (481.9 KB)

No. 3867

Certificates | Phonak

Phonak P90 -13T or P90-R or P90-RT?

Where did you buy it? Ebay?

Hello Bimodal, the correct Phonak is P90 - 13T I have already corrected the post
and I bought it on eBay
The file you uploaded is the “certificate of conformity” which I have already sent. What I am missing is the CE certificate like the one I uploaded previously, which cannot be found at Certificates | Phonak.

Yes they most definitely do, but I learnt the hard way many years ago not to specify exactly what’s in the box, so I put ear buds or headphones, never HAs, we pay GST taxes tho!

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There seem to be multiple versions of the Phonak 38657 certificate.
Sonova AG_CE_Certificate_MDR_ No 38657_rev. 4_QDL-1359 [5].pdf (617.1 KB)
Sonova AG_MDR_CE Certificate HI_No 38657_QDL-1359 - signe (4).pdf (552.9 KB)
QDL-1359_23_MDR_CE_Certificate_N_38657_rev_22_HIs_Sonova_AG_signe.pdf (996.9 KB)

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Probably this was my mistake, because I described the parcel from UK VERY accurately near the end of February :melting_face: However, I managed to change VAT from 23 to 8%.

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Also there are two documents that are a bit large and have sent you a link to them via PM.

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Hello Menglxs.

These files you attached ARE CE certified. I think they could be the ones you’re requesting, which I haven’t found anywhere. I’m going to send them to see what they tell me and see if they’ll release the product once and for all. They’ve been requesting documentation since November 2024.
Thank you very much.

Thank you, Mengs.
But the link has expired.
:pensive:

Here, it doesn’t matter what you put on it; they open the package and check what’s inside, and if you try to deceive them or don’t declare the exact product, they return it or destroy it outright. Here, you pay 21% VAT, customs fees, courier service, weekly shopping, and the lady’s hairdresser. In this case, the fees are outrageous; they charge you for things that make no sense.

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Are you sure you don’t have lower VAT percentage for medical devices?

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I’ll send you the link again in an hour.

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