Good News | The 54th Certificate! Mednovo Medical Group’s Self-developed Vitrification Solution Kit Granted Registration Approval
Recently, the Vitrification Solution Kit independently developed by Suzhou Mednovo Rui Medical Technology Co., Ltd., a subsidiary of Mednovo Medical Group, has been approved as a Class III medical device by the National Medical Products Administration (NMPA), with the registration certificate number: National Medical Device Registration No. 20263180953. This marks another key milestone for the Group in completing its product portfolio for assisted reproductive fluids, and represents the 54th medical device registration certificate obtained by the Group.
Vitrification Solution Kit
National Medical Device Registration No.: 20263180953
Vitrification is the mainstream rapid freezing technology in assisted reproduction. It treats oocytes and embryos with high-concentration cryoprotectants, enabling intracellular and extracellular fluids to instantly form an ice-free glassy state for long-term preservation. Vitrification of oocytes and embryos is a critical component of human assisted reproductive technology (ART).
Compared with conventional programmed freezing, vitrification technology features notable advantages including simple and fast operation, no dependence on expensive equipment, and an extremely high post-thaw survival rate. It has been rapidly adopted by reproductive medicine centers worldwide, providing essential core technical support for the broad clinical application of human fertility preservation, preimplantation genetic testing, and the total embryo freezing strategy.
Product Features：
Pharmacopoeia-grade raw materials with full-process aseptic manufacturing：Raw materials are strictly controlled in compliance with the Chinese Pharmacopoeia. Finished products have a bacterial endotoxin level below 0.25 EU/mL, and all indicators including sterility, elemental impurities, heavy metals, pH value and osmotic pressure meet applicable standards.
Comprehensive biosafety evaluation：DMSO, ethylene glycol and trehalose are selected as cryoprotective agents. The product has passed the mouse embryo assay, blastocyst cell staining and counting test, and genotoxicity tests (bacterial reverse mutation assay, mouse lymphoma cell gene mutation assay), demonstrating good biocompatibility with embryonic developmental potential.
Full cold chain assurance：Validated under extreme environmental conditions, the cold chain transport box can maintain a stable temperature of 2–8 °C for 72 hours. Unpacking operations do not affect the product temperature, ensuring safe delivery across the country.
Broad compatibility：Favorable compatibility with mainstream domestic and international brands.
Product Advantages：
A single reagent system covers the full developmental cycle from oocytes to blastocysts, eliminating risks from multi-system switching
The kit safely supports vitrification of human oocytes, pronuclear embryos, cleavage-stage embryos and blastocysts. Clinicians do not need to switch freezing solution systems for different sample types, which reduces errors from operational habit changes and lowers laboratory management costs.
Trehalose replaces sucrose for superior glass transition temperature and lower ice crystal risk
Trehalose solution has a higher glass transition temperature (Tg') than sucrose solution. It enters the glassy state more readily at the same cooling rate, reducing the probability of residual ice crystal formation.
High-concentration human serum albumin enhances matrix viscosity and inhibits metastable ice crystal formation
High-concentration human serum albumin increases the viscosity of the extracellular freezing solution, enabling more uniform heat conduction during cooling. It effectively prevents local supercooling and suppresses the nucleation and growth of metastable micro ice crystals.
Optimized low-cytotoxicity cryoprotectant formulation
A screened and optimized combination of low-permeability cryoprotectants is adopted. While ensuring efficient dehydration, it reduces chemical irritation to the cytoskeletal structure of oocytes and embryos, facilitating cell morphology recovery after thawing.