We did it! Our first MDR 2017/745 certificates are here!
We are proud to announce that we have obtained our first MDR 2017/745 certificate of conformity for five of our nasal medical devices. This is a major milestone that confirms the quality, safety, and effectiveness of our products in accordance with the highest standards of the European Union.
Certified medical devices:
- Isotonic sea water nasal spray
- Hypertonic sea water nasal spray
- Saline nasal rinse kit (isotonic/hypertonic)
- Lactated Ringer’s solution rinse kit
- Lactated Ringer’s solution nasal spray
This is just the beginning – more certificates are on the way, including for our cough syrups and vaginal gel. In total, we plan to certify over 30 products!
Why is MDR 2017/745 a game changer?
An MDR certificate is more than just a formality – it’s proof that our products:
✔ meet European quality standards
✔ are safe and effective
✔ can be legally marketed across the entire EU
For our partners, it also means clear benefits:
✔ ready-to-market certified products (private label)
✔ full regulatory support
✔ easier access to the OTC market
✔ strong competitive advantage
“This is the result of years of hard work by the entire team – thank you for your dedication, patience, and perseverance. This is our shared success – the first, but certainly not the last.” – A. Ziomka, Head of Registration and Quality Department.
