Good News | The 63rd Registration Certificate! Sperm Cryopreservation Medium Independently Developed by Mednovo Medical Group Approved
Recently, Medinorui Medical Technology Co., Ltd., a subsidiary of Medino Medical Group, has obtained the Class III medical device registration certificate issued by the National Medical Products Administration (NMPA) for its self-developed Sperm Cryopreservation Medium, with registration certificate No. 20263182166. This marks another important milestone for the Group in the field of assisted reproductive media and its 63rd medical device registration certificate.
With this approval, Medino Medical Group has completed its product portfolio for fertility preservation at the gamete and embryo levels, all of which hold Class III medical device registration certificates. For male applications, the Group offers the Sperm Cryopreservation Medium (Reg. No. 20263182166). For female applications, it provides the Vitrification Medium Kit (Reg. No. 20263180953) and the Warming Medium Kit (Reg. No. 20263181555). Together, these products deliver compliant and safe fertility preservation solutions for reproductive centers.
Sperm Cryopreservation Medium
(Reg. No. 20263182166)
According to the Maternal and Child Health Department of the National Health Commission, as of November 2025, there were 664 medical institutions approved to provide human assisted reproductive technology and operate human sperm banks. Meanwhile, the Chinese Expert Consensus on Autologous Sperm Cryopreservation states that the number of patients opting for autologous sperm cryopreservation in Chinese human sperm banks saw a notable upward trend between 2010 and 2020, with an average annual growth rate exceeding 10%. The eligible population for autologous sperm cryopreservation continues to expand, including patients prior to oncological radiotherapy and chemotherapy, those with severe oligozoospermia and asthenozoospermia, and patients requiring surgical sperm retrieval. The freeze‑thaw process inevitably causes damage to sperm structure. Traditional yolk‑containing cryopreservation media carry risks of exogenous contamination, and pH fluctuations are prone to occur when samples are handled at room temperature.
Addressing the clinical needs and pain points outlined in the consensus, Suzhou Medinorui Medical Technology Co., Ltd. has developed the sperm cryopreservation medium based on mHTF‑HEPES. It delivers end‑to‑end protection, stabilizing the microenvironment and preventing damage induced by ice crystal formation.
Indications
This product is intended for sperm cryopreservation in assisted reproductive procedures.
Model | （mL） | Quantity (bottle) |
RSF-10 | 10 | 1 |
Product Features
Dual Buffering System
Formulated with a dual buffering system consisting of bicarbonate and HEPES, the product performs reliably during room-temperature handling. The consensus stresses rigorous collection and processing of semen samples. HEPES buffering effectively maintains stable pH when samples are exposed to ambient air, mitigating adverse impacts on sperm motility caused by prolonged handling time.
Dual-Action Cryoprotection
Using glycerol and sucrose as cryoprotectants, the formulation is egg-yolk-free with well-defined components. Glycerol replaces intracellular water, while sucrose maintains extracellular osmotic pressure. Together, they reduce ice crystal formation and minimize mechanical damage to sperm membranes during freezing, ensuring consistent batch-to-batch quality.
Safe Nutritional Source
Pharmaceutical-grade human serum albumin is incorporated to supply high-quality, safe protein and nutritional support for sperm, delivering viable sperm for subsequent assisted reproductive techniques such as ICSI.
Anti-Contamination Barrier
The product contains gentamicin sulfate to maintain a sterile environment. As emphasized in the consensus, semen contamination risks must be guarded against. Gentamicin effectively inhibits the growth of potential microorganisms in semen and safeguards the safety of in-vitro handling.About us
Founded on January 1, 2011, Medino Medical Group is a large diversified group focused on the healthcare industry, integrating R&D, manufacturing, sales, investment and financing.
Starting its business with sales, the Group has built a nationwide sales and service network. By combining independent R&D and technology introduction, it has expanded into diversified business segments and established an initial R&D, manufacturing and operation system that meets internationally advanced standards. Adopting an innovative industry collaboration model of “financial investment plus sales partnership”, the Group joins hands with outstanding partners. It drives projects through investment and fuels growth via projects.
Going forward, the Group will continue its diversified development in the minimally invasive intervention sector. Taking sales as the foundation, guided by its strategy and backed by solid financial strength, it regards technological innovation as its key breakthrough. The Group develops high tech innovative products with independent intellectual property rights, high technical sophistication, reliable quality and affordable access for patients. It strives unremittingly to become a global integrated high tech medical solution provider in the interventional field!