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Shijiazhuang Sihua Pharmaceutical Group’s Class II non-powered sterile medical device products have been successively approved.

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Honors Announcement

发布时间：2024-04-16

【概要描述】 Following the approval of its disinfectant medical ultrasonic coupling agent, medical radiation-shielding spray, and medical liquid spray dressing, Hebei Hanlin Biotechnology Co., Ltd. of Shijiazhuang Sihua Pharmaceutical Group has recently obtained medical device registration certificates for two additional products: a sterile medical ultrasonic coupling agent and a medical gynecological gel. This milestone underscores the group’s significant progress in innovation and development within the medical device sector.

Shijiazhuang Sihua Pharmaceutical Group’s Class II non-powered sterile medical device products have been successively approved.

Following the approval of its disinfectant medical ultrasound coupling agent, medical radiation protection spray, and medical liquid spray dressing, Hebei Hanlin Biotechnology Co., Ltd. of Shijiazhuang Sihua Pharmaceutical Group has recently obtained medical device registration certificates for two additional products: a sterile medical ultrasound coupling agent and a medical gynecological gel. This milestone marks a significant step forward in the group’s innovation and development in the medical device field.

Both of the newly approved medical device products—sterile ultrasonic coupling gel and sterile gynecological gel—are Class II passive sterile medical devices.

According to available information, sterile medical ultrasonic coupling gel is applied or coated between the skin or mucosa and the radiating surface of the ultrasound probe (or therapeutic head) during ultrasonic diagnostic or therapeutic procedures. It serves as an acoustic coupling medium that facilitates the transmission of sound waves, thereby improving the ultrasonic coupling between the probe and the patient. This includes intraoperative ultrasound, percutaneous biopsy and other invasive procedures, as well as transrectal, transvaginal, and transesophageal examinations that involve direct contact with mucosal surfaces, in addition to ultrasonic examinations of non-intact skin and neonates. Medical gynecological gel, on the other hand, is indicated for patients with cervicitis, vaginitis, and cervical erosion, promoting the healing of erosive lesions and other wound surfaces, and is widely used in clinical practice.

Meanwhile, in recent years, the Group has accelerated its expansion into new growth areas and cultivated new competitive advantages by closely aligning with market demand. It has actively developed and manufactured medical devices, clinical in vitro diagnostic kits, and biologics such as antigens and antibodies, and has, for the first time in the industry, initiated the development of an innovative Class III in vitro diagnostic reagent. Currently, the Group has more than ten Class II and Class III products in development, has registered and launched two Class I in vitro diagnostic reagents for nucleic acid collection and testing, and has obtained approval for five Class II medical device products, thereby steadily enriching and diversifying its portfolio of medical devices and biologics.

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