We’re thrilled to announce that the LeadSure LS100 bipolar electrosurgical system (commonly known as LIGASURE vessel sealer) has obtained official registration certification from the Federal Service for Surveillance in Healthcare (Roszdravnadzor, RZN) of the Russian Federation. As the authorized exclusive distributor of this product in the Russian market, we will be fully responsible for its sales, technical support, and after-sales service throughout Russia effective immediately. This marks yet another overseas certification achievement, following the registration of the Leadsonic ENG300 Ultrasonic Surgical System applications in Russia in October 2025.
The product registration certificate number is Г004-00110-00/05098331 (Eurasian Economic Union unified registration number: ЕРУЛ-Г00400110-00/05098331). All information can be verified on the official website of the Federal Service for Surveillance in Healthcare of the Russian Federation: https://roszdravnadzor.gov.ru/.
About Russian RZN Certification and Class 2b Medical Devices
The Federal Service for Surveillance in Healthcare (RZN) is the highest regulatory authority for medical devices in the Russian market, and the registration certificate it issues is the only legal credential for products to enter the Russian market. The new Russian medical device registration regulations (Decree No. 1684), which came into effect on March 1, 2025, have significantly raised the entry threshold. In particular, for Class 2b medium-high risk medical devices, complete preclinical test data and multi-center clinical trial results are required, with a certification cycle typically lasting 18-24 months.
The indefinite registration certificate obtained by LeadSure LS100 not only proves that its safety and effectiveness fully comply with Russian national standards but also means that the product will be supplied to the Russian market stably for a long time in the future, eliminating the risk of supply interruption caused by periodic certificate renewal.
Product Introduction and Clinical Value
The LeadSure LS100 bipolar electrosurgical system is indicated for minimally invasive or open surgical procedures requiring ligation and cutting of blood vessels, tissue bundles, and lymphatic vessels. The system consists of a generator main unit, foot switches, and a variety of disposable pistol-type and scissor-type electrosurgical instruments, providing surgeons with a precise and efficient tissue processing solution.
As the second surgical energy platform product we have launched in the Russian market, LeadSure LS100 complements the previously RZN-certified LeadSonic ultrasonic surgical system, meeting the diverse needs of different surgical procedures.
Our Core Advantages as the Exclusive Distributor
As the only authorized exclusive distributor of LeadSure LS100 in the Russian market, we are committed to providing comprehensive professional services to Russian medical institutions and distributors:
- Stable and Reliable Supply Chain: Long-term strategic partnership with the original manufacturer to ensure continuous and stable product supply
- Professional Local Technical Support: A dedicated technical service center in St. Petersburg providing timely equipment installation, commissioning, and maintenance services
- Comprehensive Training System: Systematic product operation training and clinical application guidance for surgeons and hospital technical personnel
- Full-Scale After-Sales Service: One-stop services including product warranty, consumable supply, and technical consultation
Next Steps
The LeadSure LS100 bipolar electrosurgical system is now officially accepting orders from the Russian market.
For more information about the LeadSure LS100 bipolar electrosurgical system or cooperation inquiries, please contact our sales team:
- Email: info@czjy-med.com
- Phone: +86 1370 1494 111
