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UFSK-OSYS: Zertifizierung 1
UFSK-OSYS: Zertifizierung 2
UFSK-OSYS: Zertifizierung 3
UFSK-OSYS: Zertifizierung 4
Zertifizierung 5 - UFSK-OSYS
UFSK-OSYS: Zertifizierung 6

'Safety Tested' - Primara

UFSK-OSYS products are certified by Primara Test- und Zertifizier-GmbH in accordance with the standard IEC 60601-1 Medical Electrical Equipment Safety.

"Made in Germany" all over the world

Using state-of-the-art manufacturing technologies, our highly qualified staff is dedicated to constantly optimizing the excellence of all products made by UFSK-OSYS and bearing the prized and coveted "Made in Germany" seal of quality. The numerous other certifications bestowed on us reflect our ambition to never lose sight of our customers' satisfaction on all levels - from manufacture to advisory services all the way to outstanding customer support.

Iso 13485 Certification confirms UFSK-OSYS quality

Certification in accordance to ISO 13485:2016 underscores the high priority of quality assurance and quality optimization upheld by our organization. Our commitment to quality in the areas of customer satisfaction and service, as well as our dedication to meeting and exceeding the highest manufacturing standards, is yet again confirmed with this certification. 

ISO 13485 certifies - on the basis of a comprehensive quality management system - an organizations ability to consistently produce high quality medical devices and related services that meet all legal, regulatory and customer requirements.

The revised standard EN ISO 13485:2016 - solely valid from March 2019 – strengthens the risk-based approach to all quality processes, including the outsourced processes. This means, that risk management plays an even more important role in all areas of our company. The risk assessments to be taken integrated regulatory requirements at an early stage and support our medical devices through all phases of their life cycle.

Quality & Safety  - from the start to the end.


Please view certificate here.


Known Consignor

UFSK-International OSYS GmbH has been certified as “Known Consignor” on 4 March 2013 pursuant to chapter of Commission Regulation (EU) 185/2010.

We have our air cargo considered “secure” after this date, exempting it from standard security screening procedures before being loaded onto the aircraft. Benefits for our partners:

  • Fast and efficient handling of air freight shipments
  • No additional costs due to additional storage, X-ray, delivery delays
  • Air Freight may be shipped in passenger aircraft (more frequent flight possibilities

"FDA registered" for the U.S. American market

Our products have been approved for the U.S. American market. We are in compliance with the stringent requirements demanded by the U.S. Food and Drug Administration (FDA) for the quality management system used in production, process controlling, corrective and preventive actions, product development, and management.

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