4445 Easgate Mall, Suite 200
San Diego, 92121
United States of America, California
Toll free: (888) 204-7888
Phone: (858) 653-0084
Fax: (619) 768-2458
Description:
Axel Bio Corporation (ABCorp) is a privately held company, committed to providing top of high quality, cost effective FDA510(k) and CE Mark certified medical devices with enhanced engineered safety features to healthcare industry.
Public awareness of needlestick injuries has led to a strong urge for healthcare providers to implement safer devices to replace conventional syringes. In order to meet global demand, ABCorp provides the most cost-effective retractable safety syringe to the healthcare industry in order to prevent unsafe needlestick injections. ABCorp uses product competition analysis to evaluate and distribute high-quality, internationally certified safety devices.
We have plentiful resources of the QSR compliant, GMP, ISO9001, and ISO13485 certified manufacturers that generate high-volume and cost-effective syringes to satisfy the need of the healthcare market.
ABCorp also provides a full-spectrum consultation service for the prototype device design, product manufacturing, and marketing strategies to assist market penetration of the products.
In addition, we offer consulting services in quality and regulatory compliance for medical devices, including FDA 21 CFR 820 (QSR / cGMP), FDA 510(k) pre-market notification, and European Union CE marking& regulatory compliance. Serving as a registered US agent, ABCorp helps foreign manufacturers / establishments that import products to the USA, communicate with FDA and its inquiries.