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Author Topic: Guichet nail approved by the UK regulator or only CE mark from the EU?  (Read 184 times)

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angelica

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Guichet nail approved by the UK regulator or only CE mark from the EU?
« on: January 20, 2025, 07:57:07 PM »
Before Brexit, the UK was a part of the EU and then all medical devices approved with the CE mark were available for use in the Uk as well.

Is the Guichet nail available in the UK only because it had a CE mark or has it received a separate fresh approval from the British regulators?

In terms of regulatory strictness the UK regulator is on par with the FDA here in the US. But the CE mark is not that hard to get and is not a measure of quality.

So the question is: Does the Guichet nail have a SEPARATE approval from the British regulator?
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WishMeLuck

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Re: Guichet nail approved by the UK regulator or only CE mark from the EU?
« Reply #1 on: January 20, 2025, 08:06:00 PM »
Maybe you can ask the manufacturer.

https://x-os.eu/index.html

Let us know.
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