Kerle Medical is a hi-tech enterprise specialized in high-value medical consumables and integrating with the R&D, production and sales of medical equipment.
Kerle 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 Dilatation System, Cervical Ripening Balloon Catheter and Vacuum Wound Drainage Kit.
So far the products of Kerle 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.
Kerle 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.
Company’s Keywords:
sinus balloon dilation, eustachian tube balloon dilation catheter, wound vacuum drainage kit, cervical ripening balloon catheter, gastric tube, endometrial sampler, balloon uterine stent, ptca balloon, nylon balloon, medical silicone tube, medical silicone bulb, silicone cathether, china medical equipment manufacturer, ce, iso13485 certificate, cross drainage tube, balloon sinuplasty, negative pressure bulb, surgical balloon cathether, ent, gynaecology & obstetrics
2
medical devices
2014
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