Catheter Yokonzeka Kugwiritsa Ntchito Kwambiri Yogulitsa Urology: Ntchito za DAXAN Global OEM ODM

Pamene zinthu zofunika kwambiri pa kugula zinthu mu urology padziko lonse lapansi zikusinthasintha kuchoka pa kupezeka kwa zinthu zofunika kupita ku kukwanira kwa dongosolo loperekera zinthu, kusankha kwa Wogulitsa Catheter Wokonzeka Kugwiritsa Ntchito chakhala chisankho chokonza zinthu kwa ogulitsa omwe akumanga mizere yolimba ya mankhwala a urology. Chengdu Daxan Innovative Medical Tech Co., Ltd. yomwe imagwira ntchito pansi pa dzina la DAXAN — yapanga pulogalamu yogulitsa ma catheter ophilic hydrophilic yokonzeka kugwiritsidwa ntchito yopangidwa kuti ikwaniritse zofunikira pakugwira ntchito, kutsatira malamulo, komanso chitetezo cha odwala cha ogulitsa urology m'misika yolamulidwa.

Yakhazikitsidwa mu 2016 ndipo ikuthandizidwa ndi zaka zoposa zisanu ndi zinayi zaukadaulo wopanga ma catheter okonda madzi, DAXAN imagwira ntchito kuchokera ku malo oyeretsera okwana 6,000+ m² a ISO 13485:2016 ku Chengdu, China. Mphamvu yopangira pachaka imaposa ma catheter okonda madzi okwana 20 miliyoni, ndipo zinthu za kampaniyo zimatumizidwa kumayiko opitilira 25 ku Europe, North America, Asia-Pacific, ndi Middle East. Mndandanda wa DAXAN wokonzeka kugwiritsidwa ntchito - womwe ukuphatikizapo Duro-Pocket® closed system, Pre-Lubricated Nelaton, ndi DuroFlex™ flexible-tip catheter - umathandizidwa ndi ntchito yonse ya OEM/ODM private-label yomwe imaphimba kukula kwa FR CH06 mpaka CH24.

Ma Catheter Okonzeka Kugwiritsa Ntchito: Chofunika Kwambiri kwa Ogulitsa Urology Padziko Lonse

Zosankha zogulira zinthu zambiri mu gawo la catheterization nthawi ndi nthawi zapita patsogolo kwambiri kuposa kuyerekezera zinthu zosavuta. Ma catheter ogwiritsidwa ntchito nthawi ndi nthawi amafika atadzozedwa kale, atanyowa kale, kapena atayatsidwa kale pamalo opangira, zomwe zimachotsa njira zowonjezera zokonzekera zomwe zimafunikira ndi ma catheter otseguka. Pa njira zogulira zipatala ndi chisamaliro cha kunyumba, izi zimakwaniritsa zofunikira zopewera matenda ndikuchepetsa nkhawa kwa asing'anga ndi odwala omwe amadzipangira okha.

Matenda opatsirana pogwiritsa ntchito njira ya mkodzo (CAUTI) akadali chiopsezo chodziwika bwino m'malo omwe kugwiritsa ntchito catheter nthawi zina kumagwiritsidwa ntchito nthawi zonse kapena pafupipafupi. Mapangidwe a catheter otsekedwa komanso osakhudza ayamba kugwiritsidwa ntchito kwambiri m'misika ya ku Europe ndi North America chifukwa amachepetsa kukhudzana mwachindunji ndi pamwamba pa catheter panthawi yoyika. Kwa ogulitsa omwe amayesa mapulogalamu ogulitsa catheter nthawi zonse, kukhulupirika kwa kapangidwe ka RTU, mawonekedwe ochepetsa CAUTI, ndi kuchotsedwa kwa malamulo ambiri kwakhala njira yofunika kwambiri yopezera zinthu m'malo moganizira zachiwiri.

Mndandanda wa Zinthu za DAXAN Zokonzeka Kugwiritsa Ntchito: Duro-Pocket®, Pre-Lubricated Nelaton, ndi DuroFlex™

Mitundu ya mankhwala a DAXAN a RTU yagawidwa m'magulu atatu osiyana, iliyonse yopangidwira kugwiritsidwa ntchito kuchipatala. Pamodzi, imakhudza ana mpaka odwala akuluakulu, ana aakazi ndi amuna, komanso njira yodziwika bwino yodzipangira okha mankhwala ochepetsa ululu.

Catheter ya Duro-Pocket® Closed System Intermittent ndiyo maziko a DAXAN's no-touch RTU. Mtundu wa Ready-to-Use umabwera utasungunuka kale, osafuna mafuta owonjezera kapena kuyatsa madzi nthawi yogwiritsira ntchito. Nsonga yake yoyambira yopanda kukhudza yotsekedwa bwino idapangidwa kuti isunge kusabereka panthawi yonse yolowetsa - chinthu chomwe chimayang'ana mwachindunji kuchepetsa chiopsezo cha CAUTI. Maso opukutidwa ndi moto amachepetsa kukangana kwa mucosal ndikuchepetsa kuthekera kwa kuyabwa kwa minofu panthawi yolowetsa ndi kutulutsa. Chikwama chosonkhanitsira mkodzo chophatikizidwa chimatha kufika 1,300 mL ndipo chimapezeka m'makulidwe osiyanasiyana. Yopangidwa kuchokera ku TPU yofewa komanso yosinthika yachipatala, Duro-Pocket® RTU imaphimba ana (6-14FR), akazi (8-18FR), ndi amuna (8-18FR). Mapaketi wamba ndi mayunitsi 30 pa bokosi lililonse ndi mayunitsi 300 pa katoni iliyonse.

Catheter ya Pre-Lubricated Nelaton Ready-to-Use imagwira ntchito pamsika waukulu wa catheterization wokhazikika nthawi ndi nthawi. Yopangidwa kuchokera ku TPU yopanda DEHP komanso yopanda BPA yokhala ndi eyelets yopopedwa m'mbali, imaphimba kukula kwakukulu kuyambira kwa Ana ndi Amuna mpaka Akuluakulu Akazi ndi Amuna, kuyambira 6 mpaka 24FR. Catheter imafika ku fakitale yopaka mafuta kale popanda njira yowonjezera yowonjezera, zomwe zimapangitsa kuti ikhale yoyenera ku malo operekera chithandizo komanso njira zoperekera chisamaliro kunyumba.

DuroFlex™ Pre-Lubricated Flexible Tip ISC Catheter imamaliza mzerewu ndi kapangidwe kake kamene kamapangidwa makamaka kuti kagwiritsidwe ntchito pa urethra wa amuna. Nsonga yake yosinthasintha yooneka ngati mpira imagwirizana ndi ma curve achilengedwe ndi mawonekedwe a urethra wa amuna, zomwe zimachepetsa kukana kwa kulowetsedwa ngati pali kusiyana kwa anatomical kapena stricture ya urethra. DuroFlex™ imapezeka mu kukula kwa 10–16FR ndi 40 cm, ndipo ili ndi chikwama chogwirira chosakhudza kuti chilowetsedwe ndi dzanja limodzi mwaukhondo ndipo imayikidwa m'matumba a aluminiyamu osabala omwe ali ndi mawonekedwe awiri otseguka.

Ntchito za OEM/ODM: Mapulogalamu a Catheter Okhala ndi Zizindikiro Zachinsinsi Pa Makulidwe Onse a CH06–CH24 FR

Pulogalamu ya DAXAN ya OEM/ODM imalola ogulitsa ndi otumiza kunja kuti apange mizere ya catheter yokonzedwa bwino yogwiritsidwa ntchito ndi zinthu zomwezo zomwe zimathandizidwa ndi zomangamanga zomwezo zomwe zimathandizira zinthu za DAXAN. Zosankha zosintha zimaphimba kukula konse kwa FR kuyambira CH06 mpaka CH24, ndi makonzedwe angapo a kutalika kwa chubu, mitundu inayi ya nsonga - Nelaton yolunjika, nsonga ya mpira, nsonga yofewa, ndi Tiemann/Coudé - komanso kusankha kwa zinthu za chubu cha PVC kapena TPU. Zolemba zachinsinsi, zojambula zopangidwira, ndi mawonekedwe akunja a katoni zonse zimaperekedwa mkati mwa pulogalamu ya OEM.

Ukadaulo wopaka utoto womwe uli pansi pa zinthuzi zolembedwa paokha ndi nsanja yopaka utoto ya Coatapex™ Hydrolyx™ hydrophilic. Yopangidwa kuchokera ku chemistry ya polyvinylpyrrolidone (PVP), Coatapex™ Hydrolyx™ imapeza coefficient of friction (COF) yotsika kufika pa 0.02 ndipo imasunga mafuta ochulukirapo kwa maola opitilira 24 mutayambitsa, kuthandizira kuchepetsa kupsinjika kwabwino kwa odwala omwe amapaka katemera kangapo patsiku. Nsanja yopaka utotoyi imaphatikizaponso mphamvu zotsutsana ndi mabakiteriya, zotsutsana ndi encrustation, komanso zotsutsana ndi thrombosis pamwamba, zomwe zimapatsa ogulitsa zilembo zachinsinsi zidziwitso zaukadaulo zomwe zimapitirira zomwe zimanenedwa kale kuti catheter yopaka utoto. Nsanja yopaka utotoyi imathandizidwa ndi ma patent a DAXAN omwe amaphatikizapo ukadaulo wopaka utoto wopanda mafuta wambiri (Patent No. ZL201811203221.3) komanso utoto wopaka utoto wopangidwa ndi madzi (Patent No. ZL201810063901.3).

Ndi zaka zoposa zisanu ndi zinayi zaukadaulo wopanga zinthu zopangidwa ndi OEM komanso netiweki yogwira ntchito yotumiza kunja yomwe imafalikira m'maiko opitilira 25, DAXAN imapereka kukula kwa kupanga, zomangamanga zoyendetsera, komanso kuzama kwa kusintha komwe mapulogalamu ogulitsa ma catheter ambiri amafunikira.

Phukusi Lotsatira: ISO 13485 Cleanroom, EC MDR 2017/745, Dual FDA 510(k), ndi NMPA

Kutsatira malamulo ndi maziko a udindo wa DAXAN monga wogulitsa catheter yachipatala yogulitsa zinthu zambiri m'misika yogawa padziko lonse lapansi. Dongosolo loyang'anira khalidwe la mankhwala limamangidwa pa satifiketi ya ISO 13485:2016, muyezo wodziwika padziko lonse lapansi wa khalidwe lopanga zida zachipatala, womwe umalimbikitsa malamulo operekedwa ndi DAXAN komanso kuwongolera kupanga.

Pa mulingo wolowera pamsika, DAXAN ili ndi CE Marking pansi pa EU Medical Device Regulation 2017/745, yovomerezedwa pansi pa njira ya Full Quality Assurance, yomwe imalola kulembetsa ndi kufalitsa zinthu m'maiko onse a EU ndi EEA. Zilolezo ziwiri zosiyana za FDA 510(k) zikuphimba msika wa US: K212567 ya mzere wazinthu za catheter zosakanikirana ndi hydrophilic, ndi K243175 ya mzere wa catheter wosakanikirana wa TPU. Kulembetsa kwa FDA kwa DAXAN (FEI 3023329815) kumatsimikiziridwa payokha kudzera mu database ya FDA 510(k). Kulembetsa kwa China NMPA (kale CFDA) kumakhudza kutsatira malamulo amsika waku China ndipo kumapereka chizindikiro chowonjezera chodalirika kwa ogulitsa omwe akugula kuchokera kwa opanga ochokera ku China. Zolemba zotumizira kunja zimaphatikizapo Satifiketi Yogulitsa Yaulere ndi Satifiketi Yoyambira yoperekedwa ndi CCPIT.

Ndondomeko iyi ya malamulo atatu - yomwe ikukhudza EU, United States, ndi China kuchokera ku malo amodzi opanga omwe ali ndi satifiketi ya ISO 13485 - ndi yosiyana kwambiri pakati pa opanga ma catheter ochokera ku China, zomwe zimathandiza ogulitsa ochokera kunja kuphatikiza misika yambiri pansi pa mgwirizano umodzi wa OEM ndi zilolezo zomwe zilipo kale.

Kukula kwa Kupanga ndi Kufikira Padziko Lonse: Mayunitsi 20+ pachaka Kutumizidwa ku Mayiko Oposa 25

KUMANJAMphamvu ya kuthandizira mapulogalamu ogawa zinthu zambiri imachokera ku zomangamanga zotsimikizika zopangira. Kutulutsa kwapachaka kumaposa ma catheter opitilira 20 miliyoni okonda madzi, opangidwa mu chipinda chotsukira chopitilira 6,000 m² cha ISO 13485:2016 chokhala ndi mizere yopangira ma extrusion, molding, punching, ndi automated packaging. Kukula kumeneku kumapereka kukhazikika kwa kuchuluka kwa zinthu komanso kukhazikika kwa kutumiza komwe ogulitsa am'deralo amafunikira popanga ma portfolio azinthu za urology m'madera ambiri.

Kuyambira pomwe idakhazikitsidwa mu 2016, DAXAN yapanga netiweki yotumizira katundu kunja yomwe imafikira mayiko opitilira 25 ku Europe, North America, Asia-Pacific, ndi Middle East. Kufalikira kumeneku kukuwonetsa pafupifupi zaka khumi zaukadaulo woyang'anira kutumiza katundu padziko lonse lapansi, zolemba za misonkho, ndi zofunikira pamalamulo am'deralo - chidziwitso chomwe chimathandizira nthawi yotsogola yodziwikiratu kwa ogawana omwe akulowa m'misika yatsopano.

Ndi catheter yotsimikizika ya mizere itatu yokonzeka kugwiritsidwa ntchito, pulogalamu yonse ya OEM/ODM yachinsinsi yothandizidwa ndi nsanja yophimba ya Coatapex™ Hydrolyx™, komanso njira yotsatirira malamulo yomwe imafalikira m'misika ya EU, US, ndi China, DAXAN imapatsa ogulitsa urology wochuluka bwenzi lopanga limodzi lopangidwa kuti ligwirizane ndi zosowa za kugawa zida zamankhwala padziko lonse lapansi. Ogulitsa ndi otumiza kunja omwe akufuna kuwonanso zomwe zafotokozedwa mu malonda, malamulo a ntchito za OEM, kapena zikalata zovomerezeka akuitanidwa kuti akacheze. www.daxanmedical.com