Calmark's Neo instrument has been registered in Vietnam
Calmark Sweden AB's instrument, POC-Analyzer Neo, has been registered by the Vietnamese authorities. The associated test, Neo-Bilirubin, is still under registration process and is expected to be approved during the month of August, according to Calmark's distributor MTTS. Registration of medical devices with the authorities is mandatory before the sales start.
Calmark is collaborating with the company MTTS Co., Ltd regarding the launch, registration and sales in Vietnam, Cambodia, and Laos. The company has very good contacts with Vietnamese authorities and the instrument has now been registered. The associated rapid test for bilirubin is still in the process.
"I am very impressed with the work MTTS does for us in Vietnam", comments CEO Anna Söderlund. "They have familiarized themselves with the product in a very short time and handle the registration process in a very efficient and professional way."
Calmark POC - Neo is a platform consisting of an instrument and different test cassettes intended for the measurement of biomarkers in the blood of newborns. The first test, Neo-Bilirubin, is CE-marked and in the launch phase. Development of two additional tests is ongoing.
Every care has been taken in the translation of this document. In the event of discrepancies, the Swedish original will supersede the English translation.
For more information about Calmark Sweden AB, please contact:
Anna Söderlund, CEO
Telefon: +46 70 214 98 93
E-post: anna.soderlund@calmark.se
www.calmark.se
Calmark Sweden AB is a medical technology company that develops and markets a point-of-care (POC) analysis method with easier and faster diagnostics of medical conditions in newborns. The unique test platform consists of a portable instrument and test cassettes for various biomarkers. The first test, Neo-Bilirubin, was launched to the market in 2020. In the Western world, the introduction of POC diagnostics is resulting in huge savings and shorter care chains. In less developed healthcare systems, the product will offer a decision support which is currently lacking, since the access to hospital laboratories often is limited. Calmark aims to become the global leader in POC diagnostics for newborns and, in the long term, to offer all relevant tests for the first period of life. In addition to products for newborns, Calmark sells a POC test for assessment of COVID-19 disease severity. The B share is listed on the Spotlight Stock Market and is traded under the CALMA B ticker. Read more at www.calmark.se/eng/home.
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