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The "Disposable Use of Nasal Biliary Drainage Tube" has been a new member in the field of medical devices in Yangtze River. We have obtained the registration certificate and production license of medical devices!

Time:2021-04-14

Recently, the "disposable nasal bile drainage tube" developed by Sichuan Haihui Pharmaceutical Co., Ltd. was approved by the Sichuan Provincial Drug Administration and obtained the registration certificate and production license of the second class medical device products. This is another new ERCP surgical kit product added by Haihui Pharmaceutical Company after the "Disposable Use of Zzebra Guiding Wipe". It is also the sixth Class II medical device product registration certificate and production license obtained by Haihui Pharmaceutical Company. This move marks another solid step for Haihui Pharmaceutical Company to enter into medical devices.


Product basic information:


Commodity name: Yisaitong


Product Name: Disposable Nasal Bile Drainage Tube


Registration certificate No. : Chuanmo 20202140159


Applied departments: gastroenterology, hepatobiliary surgery


Scope of application: direct insertion of bile duct through endoscope, drainage bile.


Applicable population: acute suppurative obstructive cholangitis, which is used as decompression drainage for cholangitis, can also be used to prevent the occurrence of cholangitis after ERCP;


Bile duct obstruction caused by primary or secondary tumors;


The bile duct obstruction caused by hepatobiliary stone is also used to prevent the impaction of common bile duct stone;


Biliary pancreatitis;


Benign bile duct stricture;


Traumatic or iatrogenic biliary fistula;


Sclerosing cholangitis, can be in the bile duct drainage at the same time steroids and other drug perfusion;


Other applications, such as the treatment of gallstone dissolution, extracorporeal shock wave lithotripsy (ESWL), cholangiocarcinoma luminal radiotherapy, hepatic and biliary function detection, etc


Product features:


1. Multi-side hole design, smooth and tidy, excellent drainage effect


2, excellent bending resistance and shape memory performance, help positioning, effectively prevent catheter slip


3. Various shapes and sizes can be selected to match different patients and different lesion sites


4, superior smooth through, so that the operation is more convenient


5. Excellent flexibility, easy to pass through the narrow segment and minimize the pain and foreign body sensation of patients


6, X-ray development is good, clear positioning.


Market conditions:


As a consumable for the ERCP procedure, a nasobiliary drainage tube is used in almost every ERCP procedure. According to public data, in 2016, the number of patients receiving ERCP treatment was up to 1 million in China every year, but the number of hospitals and skilled doctors in ERCP treatment was insufficient, with only 200,000 patients receiving ERCP treatment. In the future, with the improvement of hospitals and skilled doctors in ERCP treatment, the market demand will also increase year by year. At present, the disposable nasobiliary drainage tube is being organized for production and is expected to be on the market in November 2020.