Frequently Asked Questions

IVUS products are manufactured in Denmark and other EU countries in collaboration with selected manufacturing partners.

We work systematically with supplier qualification, manufacturing processes, documentation and quality assurance throughout the product lifecycle. 

IVUS Medical focuses on product development and manufacturing.

In Denmark, Sweden, Norway, the Faroe Islands and Greenland, IVUS products are distributed by SSI Diagnostica.

For prices, quotations, orders and delivery information, please contact the distributor serving your market.

Yes. IVUS Medical operates certified management systems according to:

ISO 13485 · ISO 9001 · ISO 14001

These management systems support our work with medical device quality, regulatory compliance, continuous improvement and environmental responsibility. 

Yes. IVUS IVD products are CE marked and comply with the applicable requirements of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

The IVUS urine collection products and sample tubes are Class A IVD medical devices. 

Many IVUS products intended for sample collection are supplied sterile. Sterility status is specified on the individual product labelling and product documentation.

Our sterile urine collection products and sterile sample tubes are sterilised by electron beam irradiation. 

IVUS Medical offers both traditional urine collection solutions and closed vacuum urine collection systems.

Our traditional solutions include sterile urine cups and collection kits containing the components needed for routine urine sampling.

Our vacuum systems enable direct transfer of the urine sample from the collection container to a vacuum tube without pouring, helping to minimise contact with the sample and reduce the risk of contamination and spillage during handling. 

IVUS sterile sample tubes are designed for the collection, handling, transport and storage of biological samples such as biopsies, cerebrospinal fluid and other specimen types.

Different packaging configurations are available to support different clinical workflows, including individually packed and double-bagged variants. 

Prices, quotations, orders and delivery enquiries are handled by the distributor serving your market.

For manufacturer-related questions, product information, technical documentation or quality-related enquiries, please contact IVUS Medical. 

If you experience a quality issue or unexpected problem with an IVUS product, please contact IVUS Medical or the distributor from whom the product was purchased.

Please provide the product reference, lot number and a description of the issue. Photographs or other relevant documentation may also be helpful when investigating the matter.