Guangdong Kangerle Medical NMPA register Disposable Silicone Cervical Ripening Dual Balloon Dilation

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Product Overview

Description


Cervical Ripening Balloon Catheter


 



Product Description


 


Disposable cervical ripening balloon catheter is designed to mechanically dilate the cervical canal prior to labor induction at term when the cervix is unfavorable for induction. Cervical dilatation balloon dilates the cervix canal safely, naturally and gradually and facilitates the induced labor. The maturation and dilatation of the cervix is achieved by providing mild and simultaneous pressure on the internal and external cervical os by balloon.


 


Composition and materials


 


This product consists of catheter, balloon, distal tip, check valve, Y connector and locking loop. Catheter, tips, Y connectors and balloons are made of silicone,check valves is made of ABS and locking loop is made of PE.


 



 


 


Specification:


















Type



Catheter Diameter(fr)



Length(CM)



Volume(ml)



KEL-GJ-18F



18



40



80



 


 


Features:



 


1. Silicone dilation balloon is specially designed against such defects of latex as poor biocompatibility, easy aging and strong irritation, which can effectively improve the comfort and safety in use. Safe and non-toxic, transparent and smooth.


 


2. The wall of balloon features with thinness, toughness and smoothness. Smooth connection of the balloon to the tube body doesn’t show any visible difference in the joint, which can greatly reduce the risk of cavity trauma during intubation or extubation, and improve the comfort of the women in labor.


 


3. 80ml double balloons design maximizes the effect of cervical dilatation, with easy adaptation to the contour of cervical canal facilitating the insertion and removal.


 


4. Significantly shorten the time of head compression to the newborn.


 


5. Reduce the perinatal morbidity rates and the postpartum hemorrhage.


 


6. Effectively ripen the cervix, simplify the labor process, reduce the use of oxytocin and the rate of cesarean section, shorten the hospitalization time, facilitate the medical observation and improve work efficiency. The users are in a comfortable position,with less adverse reactions, safe and effective during the process of induced labor.


 


7. Cervical dilatation balloon is not only suitable for that who suffers from gestational hypertensive or diabetes, but specially suitable for the one in need of avoiding long time uterine contraction,such as suffering placental dysfunction, fetal growth restriction and oligohydramnion, suspected fetal distress, and scar uterus.


 


 


Usage


 


 



 





Packaging & Shipping


 


















Size



Weight



Pouch:53X9 CM


Innner box:  48X9X2 CM


1 pouch/box



 


0.07KG/box



Carton:  50X46.5X24 CM


50 boxes/Carton


4KG/Carton 

 


 





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 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 Medicals 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.      




0.0742 s.