Catheter ya DuroFlex™ yihariye ya DAXAN ifite ikoranabuhanga rya Super-Hydrophilic Coating na OEM Support
Gufata umuyoboro w’amaraso mu buryo butunguranye (ISC) bitera ikibazo cyihariye ku miterere y’umubiri w’umugabo. Uburyo bwo kugorora urethra y’umugabo busanzwe busaba ko agace ka kateteri gashobora kunyura mu miterere yayo mu gihe kagabanya kwangirika kw’imitsi no kudashyiramo uturemangingo ugereranije n’imiterere isanzwe igororotse. Ku bacuruza n’amatsinda ashinzwe gutanga amasoko basuzuma uburyo bwo gukora. Uruganda rwa DuroFlex™ rukora catheterIkibazo nyamukuru ni ukumenya niba ikintu cyakorewe mu buryo bw’ukuri ku bijyanye n’imiterere y’umugabo — cyangwa cyahinduwe kiva ku gishushanyo mbonera cy’umugabo umwe kandi kikagurishwa nk’ikijyanye n’imiterere ye.
Chengdu Daxan Innovative Medical Tech Co., Ltd. (DAXAN), uruganda rwemewe na ISO 13485:2016 rukora catheters zikozwe mu mazi zivanze n’amazi, rwakoze catheter ya DuroFlex™ isanzwe ikozwe mu mazi kugira ngo ikemure iki kibazo mu buryo butaziguye. Iyi catheter ihuza umutwe umeze nk’umupira ukozwe mu buryo bworoshye wagenewe imiterere y’umuyoboro w’inkari w’abagabo hamwe n’ikoranabuhanga rya DAXAN ryo gusigamo amazi menshi rikozwe mu mazi, rishyigikiwe na Patent No. ZL201610861058.4 kandi ryubakiwe ku buryo bwa PVP butanga coefficient of friction (COF) iri hasi ya 0.02 hamwe n’ubushyuhe buhamye bugumaho amasaha arenga 24. CE MDR 2017/745, FDA 510(k) clearance, hamwe n’iyandikishwa rya NMPA mu Bushinwa bisubiza ibicuruzwa ku nzira eshatu z’amategeko icyarimwe, hamwe no guhinduranya OEM ku ngano nyinshi z’Abafaransa.
Gutanga catheter mu gihe gito byagiye bihinduka cyane kuva ku kugereranya ibicuruzwa kugeza ku isuzuma ry’urwego rw’uruganda: amakuru y’imikorere yo gusiga, icyemezo cy’icyumba cyo gusukura, inyandiko z’amategeko agenga amasoko menshi, na serivisi za OEM ubu ni byo bituma abakwirakwiza bahitamo. Kuri buri kimwe muri ibi bipimo, Chengdu Daxan Innovative Medical Tech Co., Ltd. yubatse DuroFlex™ kugira ngo itange ibisubizo bifatika.
DuroFlex™ Flexible Ball Tip: Yakozwe mu rwego rwo kuvura indwara z'inkari z'abagabo
Icyemezo cy’ingenzi cy’igishushanyo cya DuroFlex™ ni umutwe wayo woroshye ufite ishusho y’umupira, wakorewe by’umwihariko ku miterere y’imitsi y’umuyoboro w’inkari w’abagabo. Bitandukanye n’ubundi buryo bukomeye bufite impande zigororotse, umutwe ufite ishusho y’umupira uhinduka bitewe n’imiterere karemano n’impinduka mu cyerekezo mu gihe cyo kuwushyiramo, bigabanya ubushobozi bwo kwirinda catheter ndetse n’ibyago byo gukomereka mu gice cy’umuyoboro w’inkari aho ugera. Ku barwayi b’abagabo bakora catheter inshuro nyinshi ku munsi - harimo n’abavura imikorere mibi y’uruhago rw’imitsi, imvune z’umugongo, hyperplasia y’uburemere bw’inkari (BPH), cyangwa stricture y’umuyoboro w’inkari - uduheri duto dusubiramo twiyongera tugatera kwandura no kwangirika kw’ingingo. Imiterere y’umutwe ntabwo ari ikintu cy’ingenzi cyo kumererwa neza; ni icyemezo cy’ibanze cy’ubuhanga.
DuroFlex™ iboneka mu ngano enye z'Abafaransa — 10FR, 12FR, 14FR, na 16FR — zose zifite uburebure bwa cm 40. Buri katheteri itangwa mu gafuka ka aluminiyumu gafunze neza, gapakiye ibice 30 mu gasanduku, gafite imyobo ibiri yo gucikamo uduce n'agapapuro kometseho. Agakoresho ko gufata kadakoraho gafasha mu gufata neza mu gihe cyose cyo gushyiramo, mu gihe utudomo tworoshye twahinduwe neza ku mubiri w'umuyoboro tugabanya uburibwe bw'inkari mu gihe cyo gushyiramo no gukuramo. Buri gakoresho ni gasukuye, gakoreshwa rimwe gusa, kandi gafunze aho gakorerwa, bikuraho intambwe zo gutegura aho gakorerwa. Ibisobanuro byuzuye by'ibicuruzwa biraboneka kuri Catheter ya ISC y'abagabo ikozwe mu buryo bwa “Fat-Libricated Tip” ikoreshwa mbere yo gusigwa urupapuro rw'ibicuruzwa.
Ikoranabuhanga ryo Gusiga Ingufu Zidasanzwe: Urubuga rwa Coatapex™ Hydrolyx™ rufite Imikorere Mitanu
DuroFlex™ ifite irangi rya DAXAN rya Coatapex™ Hydrolyx™ rikoresha hydrophilic coating — ikoreshwa muri PVP rigera ku gipimo cyo kugongana kugeza kuri 0.02 kandi rigakomeza kugira ubushyuhe buhamye mu gihe kirenze amasaha 24 nyuma yo gukoreshwa. Ibi ni ibipimo ngenderwaho by'imikorere bipimwa aho abasuzuma amasoko bashobora gupima irangi mu gihe cyo gutanga serivisi — ntabwo ari ururimi rwo kwamamaza. Ikoranabuhanga ryo gusiga rishyigikiwe kandi na Patent No. ZL201811203221.3 na ZL202210283147.0.
Urubuga rwa Coatapex™ Hydrolyx™ rugizwe n'imikorere itanu: gukora ku buso butagira amazi menshi, gucunga uburyo bwo gukurura ibintu, ubushobozi bwo kurwanya mikorobe (Patent No. ZL202110292008.X) - ubuso bwagenewe kugabanya gufatana kwa bagiteri, kurwanya gukurura ibintu - ubuso bwagenewe kurwanya gukurura ibintu, n'imikorere yo kurwanya gukurura ibintu (Patent No. ZL202310512495.5) - ubuso bwagenewe kugabanya ubushobozi bwo gutera amaraso. Muri rusange, iyi mirimo ikemura ingaruka ziterwa na catheter zirenze igihe cyo kuyishyiramo: kwiyongera kw'udusimba dushobora kwangiza imikorere mu gihe cyo gukoresha catheter inshuro nyinshi, n'imikoranire y'ubuso butera amaraso mu gihe cyo kuyikoresha igihe kirekire. Ku bakoresha ISC benshi - abantu bashobora kwikorera catheter inshuro enye kugeza kuri esheshatu ku munsi - guhuza ubuso bwa COF ≤ 0.02 no gukurura ibintu mu gihe cy'amasaha 24 bivuze ko irangi rikora neza kuva rikoreshejwe bwa mbere kugeza rimaze iminsi yose yo gukoresha catheter. Igishishwa cya Coatapex™ Hydrolyx™ gishyirwa kuri DAXAN Catheter ya Nelaton Straight ikunda amazi kandi, bigatuma iba urwego rutandukanya urwego rw'ikoranabuhanga mu ruganda rwa catheter rukora mu buryo butunguranye.
TPU yo mu rwego rw'ubuvuzi n'isuku ikoreshwa rimwe: Amahame ngenderwaho y'umutekano w'ibikoresho ku rwego mpuzamahanga
Katheta ya DuroFlex™ ikorwa muri TPU yo mu rwego rw'ubuvuzi - elastomer ya thermoplastic yoroshye ku bushyuhe bw'umubiri kugira ngo ihuze n'inzira y'umuyoboro w'inkari, mu gihe inyuza ku mutekano w'ibikoresho nk'uko igenzura mpuzamahanga ribisaba buri gihe. Ibikoresho nta DEHP ifite, nta BPA ifite, kandi nta rubunda rwa latex karemano, bikuraho ibibazo bitatu bikunze kugaragara ko ari allergen na plasticizer mu kugura katheta y'inkari mu masoko agengwa na EU, Amerika, na Aziya na Pasifika. Uburyo bwa TPU kandi buroroka mu buryo butekanye mu bidukikije karemano - umutungo w'ibikoresho ujyanye n'ibisabwa ku rwego rw'umucuruzi mu gutanga amasoko y'i Burayi.
Gukoresha rimwe gusa, kwangirika kw’ibinyabutabire bikuraho burundu ibyago byo kongera gutunganya, bishyigikira ububiko bw’ubuvuzi n’ubwo mu rugo, kandi bigaha abakwirakwiza imiti amahirwe yo kwirinda abarwayi no kubahiriza amategeko, ibyo bikaba bishobora kwemezwa neza mu gihe cyo gutanga ibyangombwa ku muturage.
ISO 13485 Ibikorwaremezo by'Inganda n'Iyubahirizwa ry'Amabwiriza agenga Isoko Ritatu
DuroFlex™ ikorerwa muri IBURYO's 6,000+ m² ISO 13485: Ikigo cy’isuku cyemewe na 2016 kiri i Chengdu, Sichuan — ahantu ho gukorera harimo ikoranabuhanga rigezweho ryo gusohora, gushushanya, gupfumura, no gupakira hamwe n’ikigo gipima imbere mu nzu. Ubushobozi bw’umwaka bwo gukora burenga miliyoni 20 za catheters zitwikiriwe n’amazi, bigatanga ingano y’ibikoresho bituma amasezerano y’imiterere na gahunda nini zo gukwirakwiza ibikoresho bifatika nta ngaruka mbi ku bushobozi. Umusaruro wa DAXAN wo gutwikira ushyigikiwe n’igikoresho cyayo cyo gutwikira kigenga (Patent No. ZL201610859829.6).
Ku ruhande rw’amategeko, Chengdu Daxan Innovative Medical Tech Co., Ltd. ifite ikirango cya CE hakurikijwe EU MDR 2017/745 (Full Quality Assurance route), FDA 510 (k) clearances K212567 na K243175, hamwe no kwiyandikisha muri China NMPA - imiterere y’amategeko ku isoko ritatu ishyira uruganda nk’isoko rishobora kwemezwa ry’inyandiko zitumizwa mu bihugu by’i Burayi, Amerika ya Ruguru, n’Ubushinwa icyarimwe. Nimero yo kwiyandikisha muri FDA FEI 3023329815 iragenzurwa ku mugaragaro kuri database ya FDA yo muri Amerika. Inyandiko zo kubahiriza amategeko yo kohereza ibicuruzwa mu mahanga zirimo icyemezo cyo kugurisha ku buntu n’icyemezo cy’aho bikomoka cyatanzwe na CCPIT. Yashinzwe mu 2016, iyi sosiyete imaze imyaka irenga 9 ikora ubushakashatsi n’iterambere rya catheter ikora amazi n’ibicuruzwa, hamwe n’ibicuruzwa bikwirakwizwa mu bihugu birenga 25 muri Amerika ya Ruguru, Uburayi, Uburasirazuba bwo Hagati, Aziya y’Amajyepfo y’Epfo, na Amerika y’Epfo.
Porogaramu zoroshye za OEM na Private-Label: Uburyo bwose bwa CH06–CH24 bwo guhindura ku bacuruza ku isi
Ku bacuruza n'abafite ikirango bashaka catheter zihariye zikoreshwa mu bice byihariye by'isoko, Chengdu Daxan Innovative Medical Tech Co., Ltd. itanga gahunda za OEM na ODM zigizwe n'ingano yose ya CH06–CH24 y'igifaransa, uburebure bwa catheter bwinshi, imiterere ine (igororotse, ifite ishusho y'umupira, yoroshye, na Tiemann), hamwe n'amahitamo y'ibikoresho byo gushyiramo PVC cyangwa TPU. Ibirango byihariye, imiterere y'ibipfunyika byihariye, n'ibisobanuro by'ibicuruzwa byihariye birashyigikirwa ku murongo wa DuroFlex™ na IBURYO's poroteyine yagutse ya catheter ihoraho.
Bityo, umufatanyabikorwa umwe mu nganda ashobora gutanga ibisabwa bitandukanye bya SKU ku isoko nta gutandukanya uruhererekane rw'ibicuruzwa: gahunda y'abana ijyanye n'ibicuruzwa by'i Burayi, umurongo w'abagabo bakuru ujyanye n'ibicuruzwa by'ikirangirire cyo muri Amerika y'Amajyaruguru, uruhererekane rwa Tiemann ku mucuruzi wo mu Burasirazuba bwo Hagati. Uburyo bwo guhindura ibintu - ingano za FR, uburebure bwa catheter, imiterere y'ibicuruzwa, n'uburyo ibikoresho bifatwa - bitangazwa ku mapaji y'ibicuruzwa kandi biraboneka kugira ngo byemezwe mu gihe cyo gutanga serivisi. Kugira ngo umenye byinshi ku buryo bwo guhindura ibintu, sura urubuga rwa Tiemann. Icyiciro cya DAXAN cya catheter gihoraho urupapuro.
Kuva ku nama ikoreshwa mu buryo bworoshye mu bijyanye n'imiterere y'umugabo kugeza ku buryo bwo gusiga irangi ryemewe n'amategeko, gukora ibikoresho byemewe na ISO, no guhinduranya ibikoresho byuzuye bya OEM, DuroFlex™ iha abakwirakwiza urology ku isi n'abatumiza ibicuruzwa mu mahanga igisubizo cyuzuye kandi gishoboka kugenzurwa ku isoko ryizewe. Kubijyanye n'ibicuruzwa, ibisobanuro birambuye kuri gahunda ya OEM, n'inyandiko z'amategeko, sura. Urubuga rwemewe rwa DAXAN cyangwa uhamagare itsinda ukoresheje urupapuro rw'ibibazo kuri https://www.daxanmedical.com/