On July 22, Surgia issued an announcement, and the company's "Medical Hyaluronic Acid Sodium Ecdoyin Repair Sticker" officially obtained the Class II Medical Device Registration Certificate issued by the Heilongjiang Provincial Drug Administration. The certificate number is 20262140022 and is valid until July 19, 2031.
This news spread quickly in the industry group, and many people asked me what I thought.Today, we will talk about a few points worthy of attention behind this product.
Why did "Ectoine" become the new pet?
It is not unusual for sodium hyaluronate to be used as a dressing. Micropeptide Group itself has a number of second-class device registration certificates containing sodium hyaluronate, such as Xiangji Zhengzhi 20232140861.But the addition of ectoin to medical dressings is really a new trend.
Ectoin is a natural protectant produced by extremophiles and was first discovered in the halophilic bacteria of the Salt Lake of Egypt.Its core ability is to help cells maintain normal function in extreme environments such as high salt, high temperature, and strong ultraviolet.When it comes to skin care, there are two main things to address:
① Repair light damage.After ultraviolet irradiation, the skin cell membrane structure is damaged, and ectoin can stabilize the cell membrane phospholipid bilayer and reduce the release of inflammatory factors.A 2019 study published in the Journal of Cosmetic Dermatology confirmed that 1% ectodoxine for 4 consecutive weeks significantly improved UV-induced erythema response.
② Enhance the stability of the barrier.Ectoin uses a "preferential exclusion mechanism" to form a hydrated shell on the surface of the protein, helping the stratum corneum to lock in moisture, which is critical for fragile skin after laser surgery and after fruit acid peeling.
The scope of application is the same as that of a regular dressing, but the scene is more accurate
According to the registration certificate information, the scope of application of this product is: by forming a protective layer on the surface of the wound, it acts as a physical barrier.For the care of non-chronic wounds and surrounding skin, such as small wounds, abrasions, cuts, laser/photon/fruit acid peeling/microplastic surgery.
Note that this range is not intrinsically different from ordinary sodium hyaluronate dressings, and the key difference lies in the logic of ingredient combinations.Sodium hyaluronate is responsible for "physical barrier + moisturizing", ectoin is responsible for "anti-inflammatory + stable barrier", and the two ingredients are responsible for their respective duties.This dual-acting combination has more selling points than sodium hyaluronate alone for brands that do post-medical aesthetic support products.
Shirja's "Cosmetic Symbiosis" route is getting clearer and clearer
As of this approval, there are at least 5 Class II medical device registration certificates in Shurjah's hands:
① Medical sodium hyaluronate repair patch
② Medical sodium hyaluronate repair solution
③ Medical recombinant type III humanized collagen sticker
④ Medical trehalose repair patch
⑤ Medical sodium hyaluronate ectoin repair patch (newly obtained this time)
In Q1 2026, Shurjah's revenue was 548 million, up 82% year-on-year, of which the medical device sector contributed a lot.Judging from the layout of the product line, they are going the way of "making up the brand and playing the brand, and making the mechanical brand professional".
Inspiration for OEM brands
If you are a beauty salon owner or an up-and-coming brand owner and want to develop a similar "sodium hyaluronate + ecdotine" medical dressing, you need to pay attention to 3 things:
First, the amount of ectoin added.At present, the amount of ectoin added to makeup number products in the industry is generally 0.5% -2%, but medical dressings need to be clearly formulated at the time of registration and prove safety and effectiveness.In the formula system currently being developed by the Micropeptide Group, the amount of ectoin added is controlled at 0.5% -1%, which can be effective without increasing irritation.
Second, the registration certificate application cycle.Class II devices have a normal cycle of 8-12 months from data preparation to certification.The core links include: preparation of product technical requirements, registration inspection (3-6 months), clinical evaluation (most can follow the same variety comparison path), and quality system verification.
Third, the threshold of production conditions.Medical dressings must be produced in a 100,000-stage purification workshop and be sterile throughout the entire process.Micropeptide Group Hunan Yi 'an Factory has complete Class II medical device production qualifications, and the whole process from raw materials to finished products is controllable.
Efficacy Skincare Circuit, the threshold of Class II mechanical font size is getting higher, but the opportunity is also more clear.The entry of new ingredients such as ecto into mechanical size products shows that the industry is moving in a more professional and accurate direction.If you want to lay out such products, it is more important than anything to find a foundry with registration experience and production capacity to cooperate.
(Guangzhou Micropeptide Biotechnology/Hunan Yi 'an Biotechnology, 14 years of industrial experience, 100 + Class II device registration certificates, 65 automated production lines, daily production capacity of 6 million.Please visit the official website for details if there is a need for type II machinery font size foundry.)
