Hemcheck's Newsletter - February 2022

Another month has passed and we at Hemcheck are continuing our work to build the company. We have signed a new distribution agreement with Astemed in the UAE which is positive and we also received a new order from FIND, which is the fourth order from them. The lifting of restrictions was another positive thing. When the new restrictions were imposed in December, several trade fairs planned to be held in January-March were postponed. However, given that the restrictions are now lifted, we are now looking forward to more opportunities to meet with customers at these larger events later in the spring.
Meanwhile, our transition to the new IVDR regulations is progressing according to plan, and the commercialisation efforts are ongoing where we are seeing positive user trials and starting up new user tests and trials. We are also getting positive indications from distributors that they can do more customer visits now. With regards to the ongoing war in Ukraine, we are first and foremost sad to see this happening and hope that peace can be restored as soon as possible. It has not had any effects on Hemcheck thus far but we will continue to monitor the situation.

Joen Averstad, CEO

IVDR and ISO certification

In May 2022, the new IVDR regulations will come into effect, which applies to Hemcheck's products. Since mid 2021, Hemcheck has been working on the transition including updating its quality management system, regulatory documentation, working procedures, etc. The work has progressed according to plan and we are in the final stages of completing the transition. Meanwhile we are as part of the process also preparing to certify the company according to ISO13485. The aim is that this ISO certification process will be completed in April, which would lead to Hemcheck being ISO13485 certified. This will be a quality stamp on our company, and ensure compliance to updated global regulatory requirements.

Distribution agreement signed for the UAE

Hemcheck Sweden AB has signed a three year distribution agreement with Al Shomoukh Trading for Technical & Medical Supplies EST (Astemed), one of the leading distributors of medical equipment in the UAE, with operations across the Middle East and Northern Africa.

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Additional follow up order from

Foundation for Innovative New Diagnostics (FIND)

Hemcheck Sweden AB has received a new follow up order from the Foundation for Innovative New Diagnostics (FIND) regarding delivery of reader and one-time tests (v-Test). The order is worth ca 100,000 SEK.

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Year end report and interim report Q4, 2021 (SWE)

We recently released our year end report for 2021. It has been a special year given the current pandemic situation, but despite this we have made significant progress in several important areas. We have continued our market activities with high intensity, signed several agreements, seen an increased amount of follow up orders, prepared the CE-marking of the new bgs-Test while establishing a new team to mention a few.

The report can be found here (SWE)

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Upcoming events

March 15th
EFLM Pre-analytical phase

March 15th
5th Munich Point-of-care Testing Symposium

Contact Us
Hemcheck Sweden AB
Karlstads universitet
Universitetsgatan 2
651 88 Karlstad
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