Kupanga Tekna Kumakondwerera Kukhala Ndi Mzere Wonse wa Hyperbaric Chambers tsopano CE Wotsimikizika Pansi pa Medical Device Directive
Ma Hyperbaric Chambers ochokera ku Tekna Manufacturing tsopano akudziwika ku EU ngati Medical Medical Devices. Ili ndi gawo pamwamba pamakampani ambiri'Ochita nawo mpikisano, omwe sagwirizana ndi miyezo yapamwamba iyi ndipo saloledwa mwalamulo kugulitsa zida zawo kuti azigwiritsa ntchito mankhwala.
September 9, 2020
Dziko lokonda zamankhwala ndi zaumoyo'Chidwi chozungulira zipinda za hyperbaric kuti azigwiritsa ntchito pochiza mabala osachiritsa ndipo zinthu zina zambiri zikukula. Zipinda za Hyperbaric ndi njira yosavuta yolimbikitsira odwala mpaka kawiri kapena katatu kuthamanga kwapakatikati popuma mpweya. Zipinda zingapo za hyperbaric zimaperekedwa kuti zikwaniritse zosowa zosiyanasiyana, kuphatikiza (zamabizinesi ndi osamalira) zothandizira odwala osakwatira kapena odwala angapo nthawi imodzi. Kutsogolera njira ndi ukadaulo wawo muukadaulo wa hyperbaric ndi Mtengo wa magawo Tekna Manufacturing Private Limited. M'makampani osangalatsa, Tekna posachedwa yalengeza kuti kampaniyo yalandila MD Certification MDD (motsogozedwa ndi Medical Device Directive) yazipinda zake zonse za hyperbaric, ndikuwalola kuti azigulitsa mwalamulo zida ngati zida zamankhwala zamakalasi a IIb ku European Union. Chizindikirocho chinatenga zaka ziwiri zathunthu kuti apeze ndipo ndi umboni woti kudzipereka kwa Tekna kuyenera kupanga bwino ndikupereka zida zabwino kwambiri komanso zodalirika zotheka.
"Takhala tikugulitsa malonda athu kuyambira koyambirira kwa 2000 ndikuthandizira upainiya ku USA, "atero a Todd Janca, Woyambitsa ndi Mutu wa Zomangamanga ndi New Product Development wa Tekna Manufacturing Pvt. Ltd. "Chitsimikizo cha CE chikuwonjezera pamndandanda wazovomerezeka zomwe ntchito zathu ku India zalandira, zimathandizira kukulitsa kufikira kwathu padziko lonse lapansi, komanso zimatsimikizira chitetezo ndi zinthu zathu. ”
Sriram Narasimhan, Mtsogoleri wa Tekna Manufacturing Pvt. Ltd., ali ndi chidwi chofanana ndi chiphaso chatsopanochi: "Ngakhale chithandizo chodziwika ku United States, kuzindikira za hyperbaric oxygen therapy (HBOT) kukungoyamba kukula padziko lonse lapansi. Zinthu zina zomwe zimabweretsa chidwi pamundawu ndi maphunziro angapo omwe akuwonetsa mphamvu ya HBOT pochiza odwala omwe ali ndi COVID-19. Ndi satifiketi ya CE titha kulowa m'misika yosiyanasiyana mkati ndi kunja kwa EU. Ine'Ndine wokondwa kuti tithandizira kufalitsa ukadaulo uwu. ”
Tekna Kupanga Pvt. Ltd. ikuyembekeza kuti chiphaso chawo chiziwathandiza kuti achite zosiyana ndi omwe akupikisana nawo, omwe nthawi zambiri amagulitsa ma knockoffs otsika omwe sangathe kupeza MD Certification MDD. Amalondawa saloledwa mwalamulo kutcha Hyperbaric Oxygen Therapy Chambers ngati zida zachipatala.
Malinga ndi kampaniyo, Tekna adalandira chilolezo ku US FDA ku 1999 ndipo akhala akugulitsa malonda awo ku US kuyambira pamenepo. Mu 2016, Tekna Production Pvt. Ltd. (India) idapangidwa kuti iwonjezere kufikira pazogulitsa zawo ndikupereka chithandizo kwakanthawi kwa makasitomala padziko lonse lapansi. India India adalembetsa ndi FDA, idavomerezedwa ku ISO 13485, ndipo anali m'modzi mwa oyamba kulandira MDSAP. Inalandiranso mindandanda yake ya UL ndi chitsimikizo cha CB pazogulitsa zawo mu 2019.
Akatswiri adayankha mwachidwi Tekna's Malo Othandizira Oxygen Therapy Chambers.
Dr. Tyler Sexton, Wachiwiri kwa Purezidenti wa American College of Hyperbaric Medicine, yemwe wakhala akuchiritsa odwala hyperbaric kuyambira zaka za m'ma XNUMX ndipo amaperekanso mapulogalamu angapo ophunzitsira a Hyperbaric Specialists, adati pakuwunika kwa nyenyezi zisanu, "Takhala tikugwiritsa ntchito Tekna zipinda za hyperbaric kwanthawi yayitali kwambiri. Ndiabwino kwambiri pazomwe amachita. Ndathandizira odwala zikwizikwi ndi zipinda zawo za hyperbaric ndipo ndawapeza kuti ndi zipinda zabwino kwambiri komanso zotetezeka zomwe zikupezeka [pamsika]. [Tsopano asing'anga] ku Europe [ndi ku US] atha kufikira zipinda za Tekna hyperbaric kuti akwaniritse ntchito ya HBOT. Ndikulakalaka zonse zabwino ku gulu la Tekna kuti lipeze gawo pamsika wapadziko lonse. ”
Kuti mudziwe zambiri pitani https://hyperbaric-chamber.com.
About Tekna Kupanga Zinthu
Tekna ndiye Mtsogoleri Wotsogola wa Monoplace ndi Multiplace Hyperbaric Chambers for Hyperbaric Oxygen Therapy.
Media Contact
Sriram Narasimhan
+1 (813) 773-1921
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