Pacesetter TM Automatic Clip Reusable Applier MCA-12CL

Pacesetter(TM) Automatic Clip Reusable Applier MCA-12CL

Product Spectification:

Features:

1. A simulated use extraction study was conducted to evaluate the safety of its unknown/target leachables, which proved that the target/unknown leachables contained in the product was lower potential safety risk to humans;

2. Cytotoxicity, sensitization, intracutaneous reactivity, pyrogen, acute systemic toxicity, genotoxicity, subchronic systemic toxicity and implantation experiments were performed. It proved that biocompatibility of the product meets the requirements of expected use and regulations;

3. Multiple clipping, strong convenience; disposable, weak economic.

Company Profile:

Hangzhou Sunstone Technology Co., Ltd, was established in 2005, is a manufacturing enterprise dedicated to the R&D and sales of innovative medical devices. The enterprise park covers an area of more than 7,000 square meters, and the enterprise assets exceed 30 million US dollars. The company is located in Hangzhou, China, with a production and office area of 20,000 square meters, of which the ISO 8 class cleanroom exceeds 1,000 square meters and the ISO 7 class cleanroom exceeds 500 square meters. Sunstone Technology is the first national high-tech enterprise dedicated to the research and development of absorbable medical consumables in Zhejiang Province, China. It has obtained the qualification of high-tech enterprise research and development center of Zhejiang Province Science and Technology Department of Innovation Medical Devices. Several of the unique medical devices we have developed have applied for Chinese and international patents. These projects are in different stages of research and development, some of which have entered the stage of registration and approval in China, and some in the stage of EU CE certification.