Sewon ENC "Awaiting US FDA Unique Device Identifier Confirmation, Applying for European CE"... Expanding OLED Light Patch Production Facilities

[Asia Economy Reporter Hyungsoo Park] Sewon ENC is accelerating its entry into the European market following the United States, based on its wearable OLED phototherapy patch.

On the 28th, Sewon ENC announced that it is proceeding with procedures for exporting the OLED light patch to North America and Europe.

A company official explained, "We have completed the application for the European Community certification (CE) related to the OLED light patch through the Korean Clinical Health Association," adding, "We completed the US FDA registration on the 14th and received the product unique number." He continued, "We are currently waiting for the confirmation of the FDA Registration number," and said, "Preparations for US exports are complete."

Sewon ENC plans to finalize approval procedures for overseas market penetration by completing US FDA and European CE certifications, as well as progressing with certifications such as the UK (UKCA), Australia (TGA), Singapore (HSA), and Indonesia (NA-DFC) by the end of this year.

The wearable OLED phototherapy patch business is being conducted through an industry-academia-research collaboration system. Sewon ENC, together with its affiliate GwangBio, received the original OLED phototherapy technology developed by Professor Kyungchul Choi of the Department of Electrical Engineering at the Korea Advanced Institute of Science and Technology (KAIST) and launched the OLED light patch product. Sewon ENC holds exclusive rights for manufacturing and selling the OLED light patch. GwangBio plans to produce the OLED light patches at Romical using funds invested by Sewon ENC.

With the approval procedures for overseas market entry progressing smoothly, it is expected that product commercialization will also accelerate. Romical is a specialized light source component materials company that has secured a ‘BE-OLED’ module production facility on a 49,530㎡ (approximately 15,000 pyeong) site in Hongseong, Chungnam Province. Romical’s existing cleanroom-based ultra-thin flexible OLED production line can produce over 10 million units annually. Sewon ENC is pushing for additional expansion of OLED light patch production facilities with Romical. Mass production of OLED light patches is expected to begin in earnest as early as the end of this year.

The OLED light patch business has a wide range of applications, and synergy is expected to expand the next-generation phototherapy market. Centered on Sewon ENC and GwangBio, along with the KAIST professor team and Romical, various government projects are currently underway, led by the Ministry of Science and ICT, Ministry of Trade, Industry and Energy, Daejeon City, and KAIST, including ▲ development of ultra-thin flexible OLED surface light sources for medical and skin beauty use ▲ development of low-power blood oxygen saturation / heart rate sensors for continuous medical monitoring ▲ development of OLED phototherapy patch electronic medicine and bio-healthcare application products.