I-Catheter Elungele Ukusetshenziswa Ngobuningi Yabasabalalisi Be-Urology: Izinsizakalo ze-DAXAN Global OEM ODM

Njengoba izinto eziza kuqala ekuthengweni kwempahla ohlelweni lokuhlinzeka nge-urology emhlabeni wonke zishintsha kusukela ekutholakaleni komkhiqizo okuyisisekelo kuya ekupheleleni kohlelo lokuhlinzeka, ukukhetha Umhlinzeki We-Catheter Okulungele Ukusetshenziswa sekuyinto enqumayo abasabalalisi abakha imigqa yemikhiqizo ye-urology eqinile. I-Chengdu Daxan Innovative Medical Tech Co., Ltd. esebenza ngaphansi kwegama lomkhiqizo i-DAXAN — ithuthukise iphothifoliyo ye-catheter e-hydrophilic elungele ukusetshenziswa ngobuningi eyenzelwe ukuhlangabezana nezidingo zokusebenza, ukuthobela imithetho, kanye nokuphepha kwesiguli sabasabalalisi be-urology ezimakethe ezilawulwayo.

Yasungulwa ngo-2016 futhi isekelwa yiminyaka engaphezu kweyisishiyagalolunye yesipiliyoni sokukhiqiza ama-catheter asebenzisa amanzi, i-DAXAN isebenza endaweni yokuhlanza eqinisekisiwe yi-ISO 13485:2016 engamamitha-mitha angu-6,000+ eChengdu, eShayina. Amandla okukhiqiza ngonyaka adlula ama-catheter asebenzisa amanzi ayizigidi ezingu-20, futhi imikhiqizo yenkampani ithunyelwa emazweni angaphezu kuka-25 kulo lonke elaseYurophu, eNyakatho Melika, e-Asia-Pacific, naseMpumalanga Ephakathi. Uhlu lwe-DAXAN olulungele ukusetshenziswa - oluhlanganisa uhlelo oluvaliwe lwe-Duro-Pocket®, i-Pre-Lubricated Nelaton, kanye ne-DuroFlex™ flexible-tip catheter - luhambisana nensizakalo ephelele yelebula yangasese ye-OEM/ODM ehlanganisa osayizi be-FR i-CH06 kuya ku-CH24.

Ama-Catheter Alungele Ukusetshenziswa: Okubaluleke Kakhulu Kwabasabalalisi Be-Urology Emhlabeni Wonke

Izinqumo zokuthenga ngobuningi esigabeni sokufaka i-catheter ngezikhathi ezithile zidlule kakhulu ngale kokuqhathaniswa okulula kwencazelo yomkhiqizo. Ama-catheter aphakathi alungele ukusetshenziswa afika esegcotshwe kusengaphambili, efakwe amanzi kusengaphambili, noma evuselelwe kusengaphambili endaweni yokukhiqiza, okususa izinyathelo ezengeziwe zokulungiselela ezidingekayo ngama-catheter avulekile. Ngezindlela zokuthenga esibhedlela kanye nokunakekelwa kwasekhaya, lokhu kubhekana nezidingo zokulawula ukutheleleka futhi kunciphisa umthwalo kodokotela kanye neziguli ezenza ukuzikhipha i-catheter.

Ukutheleleka kwe-catheter-associated urinary tract (CAUTI) kusalokhu kuyingozi eyaziwayo emtholampilo ezindaweni lapho kusetshenziswa khona i-catheter ngezikhathi ezithile njalo noma ngezikhathi eziningi. Imiklamo ye-catheter evaliwe kanye ne-no-touch ithole ukudonswa okukhulu ezimakethe zaseYurophu naseNyakatho Melika ngoba inciphisa ukuthintana ngqo ngesandla nobuso be-catheter ngesikhathi sokufakwa. Kwabasabalalisi abahlola izinhlelo ze-OEM zokusabalalisa i-catheter ngezikhathi ezithile, ubuqotho bomklamo we-RTU, izici zokunciphisa i-CAUTI, kanye nokususwa kwemithetho yemakethe eminingi kube yisici esiyinhloko sokuthola esikhundleni sokucatshangelwa kwesibili.

Uhlu lwemikhiqizo ye-DAXAN's Ready-to-Use Catheter: i-Duro-Pocket®, i-Pre-Lubricated Nelaton, kanye ne-DuroFlex™

Uhlu lwemikhiqizo ye-RTU ye-DAXAN luhlelwe ngemigqa emithathu ehlukene, ngayinye yenzelwe ukusetshenziswa kwezokwelapha okuthile. Ndawonye, ​​ihlanganisa izingane kuya kubantu abadala, izakhi zofuzo zabesifazane nabesilisa, kanye nezimo ezijwayelekile ngokusebenzisa izimo eziyinkimbinkimbi zokuzilungisa.

I-Duro-Pocket® Closed System Intermittent Catheter iyisihluthulelo se-DAXAN's no-touch RTU. Uhlobo lwe-Ready-to-Use lufika lunamanzi anele, aludingi ukugcotshwa okwengeziwe noma ukuvuselelwa kwamanzi lapho lusetshenziswa. Ithiphu yalo yokufaka engathinteki evalwe ngokuphelele yenzelwe ukugcina ukungazali kuyo yonke inqubo yokufaka - imininingwane ehlose ngqo ukunciphisa ingozi ye-CAUTI. Amashiya acwebezelwe ngomlilo anciphisa ukungqubuzana kwe-mucosal futhi anciphise amathuba okucasuka kwezicubu ngesikhathi sokufakwa nokukhishwa. Isikhwama sokuqoqa umchamo esihlanganisiwe siphatha kufika ku-1,300 mL futhi sitholakala ngosayizi abahlukahlukene. Yenziwe nge-TPU ethambile, eguquguqukayo yezinga lezokwelapha, i-Duro-Pocket® RTU ihlanganisa osayizi be-Pediatric (6-14FR), Owesifazane (8-18FR), kanye nowesilisa (8-18FR). Ukupakisha okujwayelekile okuthengisiwe kungamayunithi angama-30 ebhokisini ngalinye kanye namayunithi angama-300 ebhokisini ngalinye.

I-catheter ye-Pre-Lubricated Nelaton Ready-to-Use ibhekana nemakethe ebanzi ejwayelekile yokufakwa kwe-catheter ngezikhathi ezithile. Yakhiwe nge-TPU yezinga lezokwelapha engena-DEHP ne-BPA enama-eyelets aseceleni acwebezelisiwe, ihlanganisa ububanzi obukhulu kusukela kwabesifazane nabesilisa kuya kwabesifazane nabesilisa abadala, ehlanganisa i-6-24FR. I-catheter ifika efektri igcotshwe kusengaphambili ngaphandle kwesinyathelo esengeziwe sokusebenza esidingekayo, okwenza ifaneleke kahle kokubili iziteshi zokuhlinzeka ngezinsizakalo zezikhungo kanye neziteshi zokunakekelwa kwasekhaya.

I-DuroFlex™ Pre-Lubricated Flexible Tip ISC Catheter iqedela uhlelo ngomklamo owenzelwe ngqo i-anatomy ye-urethral yesilisa. I-tip yayo eguquguqukayo efana nebhola ivumelana nama-curve emvelo kanye ne-anatomical contours ye-urethra yesilisa, inciphisa ukumelana kokufakwa ezimweni zokushintshashintsha kwe-anatomical noma i-urethral stricture. Itholakala ngobukhulu obungu-10-16FR no-40 cm ubude, i-DuroFlex™ inesivikelo esingathinti sokufakwa okuhlanzekile ngesandla esisodwa futhi ipakishwe ezikhwameni ze-aluminium foil ezihlanzekile ngazinye ezinomklamo ophindwe kabili wokuvula.

Izinsizakalo ze-OEM/ODM: Izinhlelo ze-Catheter Ezinelebula Elizimele Kuzo Zonke Izilinganiso ze-CH06–CH24 FR

Uhlelo lwe-OEM/ODM lwe-DAXAN luvumela abasabalalisi nabangenisi ngobuningi ukuthi bathuthukise imigqa ye-catheter e-hydrophilic elungele ukusetshenziswa esekelwa yingqalasizinda efanayo yokukhiqiza esekela imikhiqizo yekhathalogi ye-DAXAN. Izinketho zokwenza ngokwezifiso zihlanganisa ububanzi obugcwele bosayizi be-FR kusukela ku-CH06 kuya ku-CH24, ngokulungiswa kobude beshubhu obuhlukahlukene, ukukhetha izinhlobo ezine zethiphu - i-Nelaton eqondile, i-ball-tip, i-soft-tip, kanye ne-Tiemann/Coudé - kanye nokukhethwa kwezinto zeshubhu le-PVC noma le-TPU. Ukulebula okuyimfihlo, ubuciko bokupakisha ngokwezifiso, kanye nokucaciswa kwekhathoni yangaphandle konke kufakwa ngaphakathi kohlelo lwe-OEM.

Ubuchwepheshe bokumboza obusekelwe kule mikhiqizo yelebula yangasese yiplatifomu yokumboza ephihlizayo ye-Coatapex™ Hydrolyx™. Yakhiwe nge-polyvinylpyrrolidone (PVP), i-Coatapex™ Hydrolyx™ ifinyelela i-coefficient of friction (COF) ephansi njenge-0.02 futhi igcina i-superlubricity eqinile isikhathi esingaphezu kwamahora angama-24 ngemuva kokusebenza, isekela ukunciphisa ukungqubuzana okubalulekile emtholampilo kweziguli ezifaka i-catheter izikhathi eziningi nsuku zonke. Iplatifomu yokumboza iphinde ifake izakhiwo zomphezulu ezilwa namagciwane, ezilwa nokuvuvukala, kanye ne-anti-thrombogenic, inikeze abasabalalisi belebula yangasese imininingwane yobuchwepheshe edlula izimangalo ze-catheter ezijwayelekile ezigcotshwe ngaphambilini. Iplatifomu yokumboza isekelwa yi-patent ye-DAXAN ehlanganisa ubuchwepheshe bokumboza obungenawo amandla okusebenzisa (Patent No. ZL201811203221.3) kanye ne-hydrophilic lubricious coating esekelwe emanzini (Patent No. ZL201810063901.3).

Njengoba ineminyaka engaphezu kweyisishiyagalolunye yesipiliyoni sokukhiqiza i-OEM yokumboza enamathela emanzini kanye nenethiwekhi yokuthumela ngaphandle esebenzayo ehlanganisa amazwe angaphezu kwama-25, i-DAXAN inikeza isikali sokukhiqiza, ingqalasizinda yokulawula, kanye nokujula kokwenza ngokwezifiso okudingwa yizinhlelo ze-OEM zokusabalalisa i-catheter ngezikhathi ezithile.

Iphothifoliyo yokuthobelana: ISO 13485 Cleanroom, EC MDR 2017/745, Dual FDA 510(k), kanye ne-NMPA

Ukuthobela imithetho kuyisisekelo sokuma kwe-DAXAN njengomhlinzeki we-catheter yezokwelapha ngobuningi ezimakethe zokusatshalaliswa komhlaba wonke. Uhlelo lokuphatha ikhwalithi lwakhiwe ngesitifiketi se-ISO 13485:2016, indinganiso eyaziwayo emhlabeni wonke yekhwalithi yokukhiqiza amadivayisi ezokwelapha, esekela ukuthunyelwa kwemithetho ye-DAXAN kanye nokulawula ukukhiqizwa.

Ezingeni lokufinyelela emakethe, i-DAXAN ine-CE Marking ngaphansi koMthethonqubo Wedivayisi Yezokwelapha we-EU 2017/745, ovunyelwe ngaphansi komzila we-Full Quality Assurance, ovumela ukubhaliswa komkhiqizo nokusatshalaliswa kuwo wonke amazwe angamalungu e-EU kanye ne-EEA. Imvume emibili ehlukene ye-FDA 510(k) ihlanganisa imakethe yase-US: i-K212567 yomugqa womkhiqizo we-catheter ohlala emanzini, kanye ne-K243175 yomugqa we-catheter ohlala emanzini i-TPU. Ukubhaliswa kwe-FDA Establishment Registration (FEI 3023329815) kwe-DAXAN kuqinisekiswa ngokuzimela ngedathabheyisi ye-FDA 510(k). Ukubhaliswa kwe-NMPA yase-China (eyayikade i-CFDA) kubhekana nokuthobela imithetho yemakethe yaseShayina yasekhaya futhi kunikeza isignali eyengeziwe yokwethenjwa kwabasabalalisi abathola kubakhiqizi abavela eShayina. Imibhalo yokuthumela ngaphandle ifaka isitifiketi sokuthengisa samahhala kanye nesitifiketi somsuka esikhishwe yi-CCPIT.

Le phothifoliyo yokulawula enezimakethe ezintathu - ehlanganisa i-EU, i-United States, ne-China evela endaweni eyodwa yokukhiqiza eqinisekisiwe yi-ISO 13485 - iyisici esibalulekile phakathi kwabakhiqizi be-catheter abasekelwe eShayina, okuvumela abangenisi ukuthi bahlanganise ukuhlinzekwa kwemakethe amaningi ngaphansi komlingani oyedwa we-OEM kanye nokukhishwa okukhona kakade.

Isikali Sokukhiqiza kanye Nokufinyelela Emhlabeni Wonke: Amayunithi angu-20M+ Ngonyaka Athunyelwa Emazweni Angaphezu Kwangu-25

KWESOKUDLAAmandla ka-'s okusekela izinhlelo zokusatshalaliswa ngobuningi asekelwe engqalasizinda yokukhiqiza eqinisekisiwe. Umkhiqizo waminyaka yonke udlula ama-catheter ayizigidi ezingama-20 aphilizayo, akhiqizwa egumbini lokuhlanza eliqinisekiswe yi-ISO 13485:2016 elinomthamo wokukhipha, ukubumba, ukubhoboza, kanye nemigqa yokukhiqiza yokupakisha ezenzakalelayo. Lesi sikali sinikeza ukuvumelana kwevolumu ye-batch kanye nokuqina kokulethwa okudingwa ngabasabalalisi besifunda lapho bakha amaphothifoliyo omkhiqizo we-urology wezindawo eziningi.

Kusukela yasungulwa ngo-2016, i-DAXAN isungule inethiwekhi yokuthumela ngaphandle esebenzayo efinyelela emazweni angaphezu kuka-25 kulo lonke elaseYurophu, eNyakatho Melika, e-Asia-Pacific, naseMpumalanga Ephakathi. Lobubanzi bokusatshalaliswa bubonisa cishe iminyaka eyishumi yesipiliyoni sokuphatha ukuthunyelwa kwamanye amazwe, imibhalo yentela, kanye nezidingo zomthetho zesifunda - ulwazi olusekela izikhathi zokuhola ezibikezelwayo kakhulu kubalingani bokusabalalisa abangena ezimakethe ezintsha.

Ngephothifoliyo ye-catheter eqinisekisiwe enemigqa emithathu elungele ukusetshenziswa, uhlelo oluphelele lwelebula yangasese ye-OEM/ODM olusekelwa yipulatifomu yokumboza ye-Coatapex™ Hydrolyx™, kanye nohlaka lokuthobela imithetho oluhlanganisa izimakethe ze-EU, US, kanye ne-China, i-DAXAN inikeza abasabalalisi be-urology ngobuningi umlingani wokukhiqiza womthombo owodwa owakhelwe izidingo zokusatshalaliswa kwamadivayisi ezokwelapha emhlabeni jikelele. Abasabalalisi nabangenisi abafuna ukubuyekeza imininingwane yomkhiqizo, imigomo yesevisi ye-OEM, noma imibhalo yezomthetho bayamenywa ukuthi bavakashele. www.daxanmedical.com