Galena Pharma achieves MDR Status for Four More Medical Devices!

October 3, 2023

New MDR-approved medical devices in our portfolio!

We are thrilled to announce yet another remarkable milestone in our journey of delivering top-notch medical devices to our valued clients and their consumers. With immense pride, we recently unveiled the addition to our expanding MDR-approved medical device portfolio: the publication of revision 04 of our MDR certificate. But there is more to celebrate!


We are excited to announce our most recent triumph—the brand-new MDR certificate (CR-03-1162-806-22) revision 05, officially granted by the Notified Body on the 29th of September!


For more information and detailed insights, please visit Eudamed.


Our newly MDR-approved medical devices are:

  • Zinc acetate lozenges
  • Oral honey solution for cough
  • Nasal solutions
  • Cold gels containing menthol


"This accomplishment reflects the hard work of our team and dedication to positively impacting healthcare. We extend our heartfelt thanks to our remarkable employees, loyal customers, and valued partners for their trust and unwavering support throughout our journey", rejoices Heidi Taipale.


Our experts are here to address your inquiries and guide you through upgrading your medical devices.

Heidi Taipale

Heidi Taipale
Director, Regulatory Affairs and Product Safety, PRRC
heidi.taipale (at) galena.fi

LinkedIn


For sales inquiries or more information on our medical device portfolio, write to sales(at)galena.fi.

 

Stay tuned for more news and product updates from Galena Pharma! We would love to share and celebrate our achievements and milestones with you.


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Galena Pharma is a GMP- and EU MDR -certified pharmaceutical company specializing in manufacturing and developing substance-based medical devices. Galena Pharma provides its own ready-to-market MDR-approved medical devices for in-licensing as private label products. Our focus indication areas are gastrointestinal, female intimate care, cough & cold, pain and skin care.

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