OEM Disposable Medical Device PTCA balloon dilation catheter for interventional cardiology

PTCA Balloon Dilation Catheter
Product Description
Percutaneous transluminal coronary angioplasty (PTCA) is a minimally invasive procedure to open up blocked coronary arteries, allowing blood to circulate unobstructed to the heart muscle.
Parameters
Company Information
Established on Feb 18th 2014, later among the first group of hi-tech enterprises in 2017, Guangdong Kangerle Medical Equipment Co.,Ltd (Kangerle Medical) set its production base in Pengjiang District, Jiangmen and operation center in Baiyun District, Guangzhou.
Owning its independent intellectual property, Kangerle is a hi-tech enterprise specialized in high-value medical consumables and integrating with the R&D, production and sales of medical equipment.
Kangerle Medical passed the audit of Guangdong Food and Drug Administration, and obtained the production license for medical devices (Certificate no.20142584 issued by Guangdong Food and Drug Administration on the approval of the medical equipment production); later passed the audit by TUV sud, and obtained the certificate of Quality System ISO13485-2016, CE MDD product certificates of seline;">Sinus Balloon Dilation System, Cervical Ripening Balloon Catheter and Vacuum Wound Drainage Kit.
So far the products of Kangerle Medical range from the section of ENT, Obstetrics, Cardiology, to general surgery, including such following registered devices as Eustachian tube balloon dilatation catheter, Sinus balloon dilatation system, disposable gastric tube, disposable cervical ripening balloon catheter, disposable vacuum wound drainage kit, disposable Balloon uterine stent, and disposable endometrial sampler. GMP compliant production base is equipped with the Class 10k clean room, Class 10k(partial Class 100) sterile test room, bacteria lab, positive control lab and state-approval EO sterile equipment, and professional medical device production and test instruments.
Kangerle Medical’s quality management system complys with ISO13485 and GMP which puts the production procedure in effective control and ensures the finished products meet the registered standards.
Equipped with high quality production lines, advanced production and test instruments, and professional R&D and QC team, Kangerle medical is able to provide every medical institutes with high quality products and high efficiency service.
Kangerle Medical holds the management and business principle of Manage with care, manufacture with minds, service with heart, devotes to the research, production and sales of hi-tech medical equipment, and provides the market with the most cost-effective medical equipment.
Company Development
2014: Establishment
2015: Register of Sinus Balloon Dilation System
2016: Approval of Medical Device Production. Register of Disposable Gastric Tube and Disposable Cervical Ripening Balloon Catheter
2017:Register of Disposable Vacuum Would Drainage Kit
2018: Register of Guide Needle. Register of Category II Medical Equipment Business License.
2019: Register renewal and adding models of Sinus Balloon Dilation System. Register of Nasal Irrigator and Nasal Guide Kit.
2020: Register of Eustachian Tube Balloon Dilation Catheter. Certificate ISO13485-2016 issued by TUV sud. CE MDD certificate of Sinus Balloon Dilation System, Cervical Ripening Balloon Catheter, and Vacuum Wound Drainage Kit.