Ukukhiqizwa KweTekna Kubungaza Ukuba Nomugqa Ophelele Wamagumbi E-Hyperbaric manje sekuqinisekiswe yi-CE Ngaphansi Kokuqondiswa Kwedivayisi Yezokwelapha

Ama-Tekna Hyperbaric Chambers manje aqinisekiswe yi-CE Ngaphansi Kokuqondiswa Kwedivayisi Yezokwelapha

Ama-Hyperbaric Chambers avela eTekna Manufacturing manje asehlonishwa e-EU njengamadivayisi wezokwelapha aqinisekisiwe. Lesi yisinyathelo esingenhla kuningi lenkampani'esincintisana nabo, abangahlangabezani nalezi zindinganiso ezisezingeni eliphakeme futhi abavunyelwe ngokomthetho ukumaketha amadivayisi abo ukuze asetshenziselwe ukwelashwa.

September 9, 2020

Izwe lomthandi wezokwelapha nezempilo'Inzalo ezungeze amakamelo e-hyperbaric ukuze isetshenziswe ekwelapheni amanxeba angapholi futhi kunezinye izimo ezahlukahlukene ezikhulayo. Amakamelo we-Hyperbaric ayindlela ehlaselayo yokucindezela iziguli kuze kube kabili noma kathathu ingcindezi evamile yomkhathi ngenkathi uphefumula umoya-mpilo. Kukhethwa amakamelo we-hyperbaric ukuhlangabezana nezidingo ezahlukahlukene, kufaka phakathi (zamabhizinisi nabanakekeli) ukwelapha iziguli ezingashadile noma iziguli eziningi ngasikhathi sinye. Ukuhola indlela ngobuchwepheshe babo kubuchwepheshe be-hyperbaric I-Tekna Manufacturing Private Limited. Ezindabeni ezithokozisayo zomkhakha, uTekna usanda kumemezela ukuthi inkampani ithole i-CE Certification MDD yabo (ngaphansi kwe-Medical Device Directive) ngalo lonke uhla lwayo lwamakamelo e-hyperbaric, ebavumela ukuthi bathengise ngokusemthethweni amadivayisi njengamadivayisi wezokwelapha wesigaba IIb e-European Union. Lesi sitifiketi sithathe iminyaka emibili egcwele ukusithola futhi siyisivumelwano sokuzinikela kweTekna okufanele ikhiqize futhi ihambise amadivayisi ahamba phambili futhi athembeke kakhulu.

"Besilokhu sikhangisa imikhiqizo yethu kusukela ekuqaleni kweminyaka yama-2000 futhi sisize ama-hyperbarics angamaphayona e-USA, ”kuphawula uTodd Janca, uMsunguli kanye neNhloko Yezobunjiniyela kanye Nokuthuthukiswa Komkhiqizo Omusha weTekna Manufacturing Pvt. Ltd. "Isitifiketi se-CE singeza ohlwini lwezitifiketi imisebenzi yethu yase-India esikutholile, sisiza ukwandisa ukufinyelela kwethu emhlabeni wonke, futhi siqinisekisa ukuphepha nekhwalithi yemikhiqizo yethu. ”

Sriram Narasimhan, Umqondisi weTekna Manufacturing Pvt. Ltd., unomdlandla ofanayo ngesitifiketi esisha: “Nakuba kuwukwelapha okuvamile e-United States, ukuqwashisa nge-hyperbaric oxygen therapy (HBOT) kusanda kuqala ukukhula emhlabeni wonke. Ezinye izinto ezithakaselayo eziletha ukunakekela kulo mkhakha izifundo eziningi ezibonisa ukusebenza kahle kwe-HBOT ekwelapheni iziguli ezingenwe yi-COVID-19. Ngesitifiketi se-CE singangena ezimakethe ezahlukahlukene ngaphakathi nangaphandle kwe-EU. I'ngiyajabula ukuthi sizofaka isandla ekusabalalisweni kwalobu buchwepheshe. ”

Tekna Ukukhiqiza Pvt. Ltd.ithemba ukuthi isitifiketi sabo sizobenza bakwazi ukugqama kulabo abancintisana nabo abangaqinisekisiwe, abavame ukuthengisa ama-knockoffs asezingeni eliphansi angakwazi ukuthola i-CE Certification MDD. Laba bathengisi abavunyelwe ngokomthetho ukufaka amalebuli abo e-Hyperbaric Oxygen Therapy Chambers njengamadivayisi wezokwelapha.

Ngokusho kwenkampani, uTekna uthole imvume yabo ye-US FDA ngo-1999 futhi bebelokhu bethengisa imikhiqizo yabo kulo lonke elaseMelika kusukela lapho. Ngo-2016, iTekna Manufacturing Pvt. I-Ltd. (India) yasungulwa ukukhulisa ukufinyelela kwemikhiqizo yabo emhlabeni wonke futhi inikeze izinsizakalo ezifika ngesikhathi kumakhasimende emhlabeni jikelele. Isikhungo saseNdiya sibhaliswe ne-FDA, siqinisekiswe nge-ISO 13485, futhi saba phakathi kwabokuqala ukuthola i-MDSAP. Iphinde yathola uhlu lwayo lwe-UL kanye nesitifiketi se-CB ngemikhiqizo yabo ngo-2019.

Ochwepheshe baphendule ngothando kuTekna'Amakamelo Wokwelashwa Kwe-Oxygen Hyperbaric.

UDkt.Tyler Sexton, Iphini Likamongameli we-American College of Hyperbaric Medicine, obelapha iziguli ezine-hyperbaric therapy kusukela ngeminyaka yamashumi ayisishiyagalolunye futhi unikeza nezinhlelo eziningi zokuqeqesha Ochwepheshe be-Hyperbaric, kusho ekubuyekezweni kwezinkanyezi ezinhlanu, “Besisebenzisa iTekna amakamelo we-hyperbaric isikhathi eside kakhulu. Bangcono kakhulu kulokho abakwenzayo. Ngilaphe izinkulungwane zeziguli ngamakamelo azo e-hyperbaric futhi ngazithola zingamagumbi amahle kakhulu futhi aphephe kakhulu atholakala [emakethe]. [Manje odokotela] kulo lonke elaseYurophu [nase-US] bangafinyelela amakamelo we-Tekna hyperbaric wokusebenzisa i-HBOT ekusebenzeni kwabo. Ngifisela konke impumelelo eqenjini laseTekna ekutholeni isabelo semakethe yomhlaba. ”

Ukuze uthole olunye ulwazi vakashela https://hyperbaric-chamber.com.

Mayelana ne-Tekna Manufacturing

I-Tekna ingumkhiqizi oholayo we-Monoplace kanye ne-Multiplace Hyperbaric Chambers ye-Hyperbaric Oxygen Therapy.

Media Contact

Sriram Narasimhan

+1 (813) 773-1921

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