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MDR ready.
We are at the forefront!

‘‘Hi, my name is Bettina Pajunk-Wiedmann

I would like to inform you about the latest news in the area of #wearepajunk“

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14.02.2021

MDR ready. We are at the forefront!

Since 2019, PAJUNK as a company, has been certified according to the MDR (Medical Device Regulation).

Now we are pleased to announce that we have received our first product MDR certification, covering our class Ir Minimally Invasive Surgery (MIS) products listed below:

 

Certified MIS Products

  • EcoBalloon OBT RA(-S)
  • EcoBalloon OBT DIL
  • EcoBalloon OBT SB
  • EcoBalloon PROTECT(-S)
  • TrocaObt HASSON
  • TrocaObt PYRAMID
  • TrocaObt CONE
  • TrocaObt SHIELD
  • TrocaObt PROTECT
  • EcoAx
  • Needle Holder

 

For 2021, we have some of our high-risk products on the schedule, such as our Tuohy and SPROTTE® needles. We will keep you updated on this development. 

"More Information About The MDR?

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