TENTECH Pursues Entry into Türkiye, the Gateway to Europe and the Middle East, Based on CE MDR... Strengthens Cooperation with Local Medical Device Distributors

TENTECH Inc. (CEO Han Dong-ok, hereinafter "TENTECH"), a company specializing in aesthetic medical devices, announced its push to enter the Turkish market, a key hub connecting the European and Middle Eastern markets.

TENTECH is establishing a strategic partnership with a leading local medical device distributor in Türkiye and is currently discussing cooperation for the local supply of its medical device lineup, including its monopolar RF device, '10THERMA'.

Türkiye is a country with a highly developed medical aesthetic and medical tourism market. It is considered a major hub for the aesthetic medical device industry, serving as a gateway to the European market and connecting the Middle Eastern and Eurasian markets. Considering these geographical and industrial characteristics, TENTECH views Türkiye as a key strategic country for its global market expansion.

TENTECH is pursuing entry into the Turkish market based on its 'CE MDR (Medical Device Regulation)' certification, the regulatory standard of the European Union. CE MDR is a regulation with strengthened clinical evaluation, safety, and quality management standards compared to the previous Medical Device Directive (MDD). It is evaluated as a highly reliable and widely accepted standard not only throughout Europe but also in the EMEA (Europe, the Middle East, and Africa) region, including Türkiye.

The Turkish distributor currently in cooperation talks is a company with extensive business experience, a strong network of hospitals and clinics, and profound expertise in the dermatology and aesthetic sectors within the local medical aesthetic market. TENTECH plans to lower initial market entry barriers by leveraging its partner's sales infrastructure and market understanding, aiming for a successful market landing and increased brand awareness among major local medical professionals and clinics.

The global sales performance of 10THERMA is also expected to serve as a strong foundation for entering the Turkish market. Following the sale of approximately 1,000 units domestically, 10THERMA has recorded cumulative overseas sales of about 1,000 units—centered on global hubs—just three years after its full-scale overseas expansion. Based on this global sales experience, TENTECH plans to drive the business expansion of 10THERMA within the EMEA region through this entry into Türkiye.

Han Dong-ok, CEO of TENTECH, stated, "Türkiye holds immense significance as a core bridgehead connecting the massive medical aesthetic markets of Europe and the Middle East." He continued, "A powerful synergy will be created by combining TENTECH's technological prowess, verified by the stringent European CE MDR certification, with the robust network of our local distribution partner." He added, "Using this entry into Türkiye as a stepping stone, we will further solidify our global partnerships and significantly expand our market share across the entire EMEA region."

Meanwhile, TENTECH has secured regulatory approvals in major advanced and emerging markets, including the U.S. FDA, Europe's CE MDR, Brazil's ANVISA, Australia's TGA, and India's CDSCO. Following its success in Asia and the Americas, the company is continuing to broaden its global supply chain into key hubs in Europe and the Middle East.