Winia Dimchae's 'Vaccine Freezer' Receives MFDS Certification... Full-Scale Domestic and International Sales Begin

Winia Ultra-Low Temperature Vaccine Storage Freezer 'MediBox'

[Asia Economy Reporter Kim Hyewon] Winia Dimchae's ultra-low temperature freezer 'MEDIBOX,' developed by Winia Dimchae and manufactured by Daeyu Plus, has completed product certification from the Ministry of Food and Drug Safety.

Winia Dimchae announced on the 23rd that its affiliate Daeyu Plus completed the Good Manufacturing Practice (GMP) certification for MEDIBOX and finalized the Ministry of Food and Drug Safety product certification, officially launching domestic sales of the ultra-low temperature freezer capable of safely storing all COVID-19 vaccines. Winia Dimchae completed the development of the ultra-low temperature freezer in January this year and finished trademark registration and related technology patent applications for MEDIBOX.

Although Winia's ultra-low temperature freezer was initially developed as a vaccine storage freezer, there is no classification standard for vaccine freezers under the domestic medical device classification system, so it was registered as a blood freezer. Currently, it has obtained product certification from the Ministry of Food and Drug Safety as a "blood freezer used for freezing blood or drugs or refrigerating drugs." Daeyu Plus, which co-developed the Winia ultra-low temperature freezer, received a medical device manufacturing license from the Ministry of Food and Drug Safety.

Winia Dimchae plans to first register the product on the Public Procurement Service's Nara Marketplace through this product certification and actively respond to public demand from health centers and national and public hospitals. Subsequently, it plans to expand sales channels to private hospitals, pharmaceutical companies, and others, contributing to the formation of small-scale cold chains. To this end, Winia Dimchae also obtained a medical device sales business registration certificate on the 17th.

According to the company, Winia's ultra-low temperature freezer applies a wide temperature range compared to other products currently on the market, enhancing usability for vaccine storage. Despite being a compact ultra-low temperature freezer with a capacity of 92 liters and weighing 65 kg, it can store vaccines for 18,000 people per unit.

Winia's ultra-low temperature freezer can be set from -75℃ to 10℃, allowing customized storage of all domestic COVID-19 vaccines. It features a built-in menu that enables selection of different storage temperatures for each vaccine, allowing optimal temperature settings without separate training. In addition to vaccines, it can store temperature-sensitive items such as blood, reagents, and pharmaceuticals, making it versatile for life sciences, clinical, and commercial applications.

To achieve a wide temperature range, Winia Dimchae equipped the ultra-low temperature freezer with a dual inverter compressor using inverter control technology and designed it to operate for a certain period on a small battery during power outages.

After completing registration with the U.S. Food and Drug Administration (FDA) in March, Winia Dimchae obtained ISO13485 certification for the medical device quality management system for export and recently completed manufacturing certification from the Ministry of Food and Drug Safety, successfully making its first export to the United States. Winia Dimchae is considering exports to countries such as Mexico, India, and Russia following the U.S.

A Winia Dimchae official said, "This manufacturing and product certification from the Ministry of Food and Drug Safety officially recognizes the performance and quality of Winia's ultra-low temperature freezer." He added, "Winia Dimchae will do its utmost to supply ultra-low temperature freezers that can safely and quickly distribute COVID-19 vaccines, striving for herd immunity and doing its best for the safety and health of the public."

This content was produced with the assistance of AI translation services.