EN 166 (Face shields, goggles)
CE marking of personal protection equipment (PPE) for care units
WE deliver complete CE marking for googles and face shields and other personal protective products.
swift, Smooth and cost eFfective!
Due to the unprecedented times the EU commission has approved a COVID-19 fast track for PPE for care units that is valid for 1 year after approval. In Sweden this means that the swedish work authoritiy (Arbetsmiljöverket) can approve a CE marked PPE if it has been tested at a Notified Body (In Sweden: RISE). This process is swift and takes 1-2 weeks and once approved you can sell the product to a named customer until the end of 2020. Note, the product is then NOT CE marked. A full CE mark via RISE costs a lot more and takes longer but it is then CE marked and can be sold on the open market.
Once this became clear to us at Zatisfy and we saw the costs and delivery times involved we decided to try to find alternative solutions and we did! For a complete CE mark we are cheap, have a short delivery time and offers a smooth ride, we manage it all!
The result is a CE marked product, tested and certified at a notified body in Europe.
We can offer similar solutions for face masks and googles. Contact us today for more information!
How does the Zatisfy process work?
We build the technical file, user manual, risk assesment etc.
You will also receive a list of requirements that your product needs to comply with.
We will match the documents vs the requirements from the NB.
The techincal file and samples are sent to the testlab (approved notified body according to Nando) for testing.
The product is CE marked!
"I am very pleased with the fact that we so swiftly can help provide CE marked and approved protection equipment to those in care units"
Roberth Jonsson, CEO, Zatisfy AB