Capitainer Offers Complete Self-Sampling Kits – Now Available Within the EU and the UK
Capitainer, a leading Swedish MedTech company specializing in advanced self-sampling solutions, has registered complete self-sampling kits with the Swedish Medical Products Agency. The kits contain all the components necessary for at-home self-sampling and are now available within the EU and the U.K., in compliance with the MDR. The product allows the company’s customers to offer services based on Capitainer’s sampling cards.
Capitainer's self-sampling kits are CE-marked and registered as in vitro diagnostic products under the EU’s IVD regulation (In Vitro Diagnostic). In addition to Capitainer’s sampling cards, a few small components, such as a lancet and a plaster, are required to perform the sampling. These components are easily accessible, but to offer a complete self-sampling service, the entire kit must comply with regulatory requirements and be registered under the MDR (Medical Device Regulation).
Capitainer's self-sampling kits meet regulatory requirements across the EU and the U.K. and are now approved and available on the market. This means Capitainer can offer its customers a complete package to establish services based on Capitainer’s technology.
The self-sampling kit comes in a flat, small paper package that can easily be sent by regular mail to the recipient and then returned to the laboratory for analysis.
“Many customers have requested a ready-made solution to avoid handling the registration processes for their kits. By offering a complete solution, we can better meet our customers’ needs and expectations. This allows them to reach their patients more efficiently and introduce Capitainer as a solution for all groups who can benefit from self-sampling, so patients don’t need to visit a healthcare facility for a venous blood sample,” says Mikael Ström, Business Development Director at Capitainer.
For more information, please contact:
Christopher Aulin, CEO
Phone: +46 (0)708 977577
Email: christopher.aulin@capitainer.com
About Capitainer
Capitainer AB is a Swedish MedTech company that develops and sells patient-centric solutions for self-sampling of blood, plasma, and urine. Founded in 2016, Capitainer has developed unique technologies for collecting and drying exact volumes of fluid within easy-to-use sampling cards. These cards may be sent as standard post to relevant testing laboratories, thus bypassing the need for cold chain logistics and specialised packaging. Capitainer’s products are market-leading with respect to precision and accuracy, with demonstrated equal performance to established pipetting methods. The products are applicable within several market segments, including but not limited to, clinical biomarkers, therapeutic drug monitoring, genomics, drug abuse and doping testing, and R&D and clinical studies.
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