In this blog entry we are keeping you posted about some exciting developments regarding our CE Marking.
As you know, we need this to sell our product in Europe, and we have just been granted this Marking through official channels.
Get this story in German here / auf Deutsch hier.
1. CE mark received
In October 2017, we informed you that we were unable to avoid a short delay concerning obtaining the CE Marking in Europe.
This was needed to be able to sell our DiLumen product in Europe. The European Commission describes the CE Marking as follows:
The letters ‘CE’ appear on many products traded on the extended Single Market in the European Economic Area (EEA). They signify that products sold in the EEA have been assessed to meet high safety, health, and environmental protection requirements. When you buy a new phone, a teddy bear, or a TV within the EEA, you can find the CE mark on them. CE marking also supports fair competition by holding all companies accountable to the same rules. (for details see EC – CE marking)
The UK government describes the CE marking as something that:
- shows that the manufacturer has checked that the product meets EU safety, health or environmental requirements,
- indicates to the buyer that the product complies with EU legislation, and
- allows the free movement of a product that has the CE marking within Europe, i.e. the EU and EEA (European Economic Area, which includes Norway, the Principality of Liechtenstein, and so forth).
Lumendi got delayed with this work due to circumstances outside our control. At the time, we thought that this would take only a few more weeks, but unfortunately our market launch in Europe was strongly affected by this delay.
2. What does the CE 667497 mean?
The letters “CE” are the abbreviation of French phrase “Conformité Européene”. This literally means “European Conformity”.
The CE marking on our DiLumen product indicates to government officials that our product can be legally placed on the market in their country.
3. What is your opinion?
We have explained that Lumendi has developed devices that enable less invasive endoluminal surgical procedures in the gastrointestinal tract.
The DiLumen product focuses on making medical procedures faster, easier and more efficient. This helps patients and surgeons alike.
We can now start selling our DiLumen product in Europe, meaning all EU Member States, as well as those in the European Economic Area (EEA), EFTA and so forth.
Your opinion matters to us. What are your thoughts?
- Need to know who is selling our product in your country? Just ask, we will let you know!
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- Do you have questions? We love to hear from you, and will answer you quickly!