Медицинский инструмент ЛОР-устройство одноразовая система диляции надувных

 Sinus balloon dilation is a procedure involving placing a tiny and flat balloon in the sinus ostium with the assistance of nasal endoscope. When the balloon inflates, the sinus passage which was contracted or blocked due to the inflammation, will be restored to normal or slightly enlarged , so that the air enters into the sinus smoothly, and later with the saline flushing in the sinus cavity, the treatment reaches its intended outcomes. Studies show that the procedure can successfully dilate the sinus ostia and spaces without causing any complication or adverse reaction and its safety is also verified by the CT scans before and after the procedure, multi-dimension endoscopic and general examinations .

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 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 Drain 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.