We are happy to announce that the Notified Body SGS Fimko (CE0598) has issued an MDR certificate for its first client in Germany.

Gründler GmbH in Freudenstadt (Baden-Württemberg) is the manufacturer of the innovative medical product Ventilution®.

This product improves the efficacy of mechanical ventilation for patients in intensive care unit.

We congratulate the Gründler team on this achievement and are looking forward to serving more customers in Germany and abroad.

On our website CE Marking of Medical Devices you can find information about the certification process and contact our medical device certification team in Germany.

SGS offers MDR Certification on behalf of its MDR Notified Body SGS Fimko Oy (CE0598) within a wide scope of notification: SGS Fimko Oy Notification Scope.

We are able to offer the certification services in a timely manner, without long waiting times. You are welcome to contact us by This email address is being protected from spambots. You need JavaScript enabled to view it.. We will explain our MDR certification process at SGS to you and answer your questions.

Your contact

Armin Hudetz
t: +49 89 78 74 75-133
f: +49 89 12 50 40 64-133
E-Mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

Customer Service Team
t: +49 89 78 74 75-222
f: +49 89 12 50 40 64-100
E-Mail: This email address is being protected from spambots. You need JavaScript enabled to view it.

Links

Information about our Medical Device Services
CE Marking of Medical Devices
Notification Scope of SGS Fimko Oy Notified Body 0598
SGS Fimko (NB 0598) Standard fees list for MDR (EU) 2017/745 EC Certification
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