▶ Obtained FDA certification for the second time following ‘STERLINK 15sp’, the first non-American company to receive FDA certification

▶ Local U.S. business partners… Welcome to the news of obtaining FDA certification... Accelerating market expansion in the U.S.

Plasmapp (405000), a bio plasma deep tech company, announced that its small plasma sterilizer (brand: STERLINK mini) and accessory cartridge (STERLOAD mini) have been certified by the U.S. Food and Drug Administration (FDA).

‘STERLINK mini’, which received FDA approval this time, is a smaller version of the plasma sterilizer ‘STERLINK 15sp’, which became the first non-American company to obtain FDA certification in 2021.

As both ‘STERLINK mini’ and ‘STERLOAD mini’, the sterilizing cartridge used in the product, obtained FDA certification, Plasmapp obtained its second US FDA certification and FDA medical device certification in a total of 15 countries.

In particular, considering that Plasmapp's 'STERLINK 15sp' was the only small sterilizer that received FDA certification in the U.S., there were expectations in the market that Plasmapp was seeking to enter the U.S. market in earnest based on its diversified product lineup. showed it

Samjeong Yoon, CEO of Plasmapp, said, “Rather than focusing on sales of individual sterilizers, we aim to build a portfolio of FDA-certified sterilizers of various sizes in the U.S. market, and based on this, create an ecosystem for sterilization solutions ranging from sterilizers to consumables to warranty systems in the entire medical device market. “We are aiming for it.” He stated that he will continue to expand his FDA certification lineup.

The compact plasma sterilizer 'STERLINK mini' not only increases the instrument lifespan by three times compared to autoclave equipment, which is a high-pressure steam sterilization system, but also increases the turnover rate of surgical tools by more than 30 times, meeting both the economics and efficiency of infection control that have emerged since the post-coronavirus era. This is the product I ordered.

It is more compact than the existing ‘STERLINK 15sp’, providing an appropriate size for use in small spaces such as treatment rooms and operating rooms, and faster sterilization performance.

The sterilization cartridge 'STERLOAD mini', an accessory to 'STERLINK mini', can immediately sterilize various medical instruments in a chamber space of about 7L in at least 12 minutes, and can be maintained in a clean condition with no residue after the sterilization process, making it easy to use and maintain. It's easy.

Meanwhile, the FDA certification of the two products once again proves that Plasmapp's sterilization solution provides safe and effective sterilization at a world-class level, and is expected to accelerate its entry into the U.S. and overseas markets.

Marty Trabish, CEO of Plasmapp's US branch, said, “Our local clients, medical device supplier ‘QMED’ and ‘Covetrus’, the No. 1 company in sales in the global animal hospital market, especially welcomed the news of obtaining this certification.

“We will accelerate the expansion of the U.S. market and target American customers.”

Plasmapp declared that it will continue to pursue global overseas certification in the future, and based on this, secure customers in the market and further expand the overall market for sterilization solutions.

Industry insiders expressed their expectations that Plasmapp's securing of various certifications will play a role in controlling the indiscriminate entry of copy cats into the market along with the expansion of the market.