ISITifiketi se-EC

Uhlelo Lokuqinisekisa Ikhwalithi Egcwele

Inombolo Yesitifiketi.

10000322014-PA-NA-IND PRJC-581415-2018-PRC-IND

Lokhu kwenzelwa ukuqinisekisa ukuthi uhlelo lwekhwalithi lwe:

27 May 2024

I-Tekna Manufacturing Private Limited

C19, Industrial Estate, Guindy, Chennai - 600 032, India.
Ngokuklanywa, ukukhiqizwa nokuhlolwa kokugcina komkhiqizo / ukuhlolwa kwe-:

IZIMPAHLA ZOKUSEBENZA NGOKUPHELELAYO

Kuhloliwe maqondana nalokhu:

INQUBO YOKUHLOLA UKUSETSHENZISWA KOKUSETSHENZISWA KWENQUBOMGOMO ECHAZIWE KWISITHASISELO II NGAPHANDLE KWESIGABA 4 SOMKHANDLU WOKUYALELA 93/42 / EEC KUMADIVAYISI OKWEZEMPILO, NJENGOBA KUCHIBIYELWE

futhi kutholakale ukuthi kuyahanjelwa.

Imininingwane ethe xaxa yomkhiqizo (we) kanye nemibandela yesitifiketi inikezwa ikhasi elengeziwe.

Indawo nosuku:

IHøvik, ngomhlaka 08 Julayi 2020

Ku:

I-DNV GL PRESAFE AS Inombolo Yomzimba Eyazisiwe: 2460

______________________________________________________________________________

UMariann Jeremiassen

Isitifiketi siqinisekiswa ngamadijithi ubuchwepheshe be-blockchain. Ngemininingwane engaphezulu, bona www.dnvgl.com/assurance/certificates-in-the- blockchain.html

Prod 021

Isaziso: Isitifiketi singaphansi kwemigomo nemibandela njengoba kubekiwe Esivumelwaneni Sezitifiketi. Ukwehluleka ukuthobela kungenza lesi Sitifiketi singasebenzi.

UMZIMBA OZISISIWE: DNV GL PRESAFE AS, Veritasveien 3, N-1363 Høvik, Norway - Inombolo Yebhizinisi Elibhalisiwe: NO 997 067 401 MVA.

I-MSD-CO-078-A Rev 0.0 Ikhasi 1 kwe-3

Inombolo Yesitifiketi.

10000322014-PA-NA-IND PRJC-581415-2018-PRC-IND

Amandla

27 May 2020

Ukusetshenziswa koMyalelo Womkhandlu 93/42 / EEC wangomhla ziyi-14 kuNhlangulana 1993, owamukelwa njenge- “Forskrift om Medisinsk Utstyr” nguMnyango Wezempilo Nokunakekelwa Kwezinsizakalo waseNorway.

Umlando wesitifiketi:

Incazelo Yokubuyekeza

0.0 Imikhiqizo Yesitifiketi Sangempela embozwe yilesi Sitifiketi:

Usuku okukhululwa ngalo

2020-07-08

Class

IIb

Product Incazelo

I-Monoplace Hyperbaric Chambers

Hlanganisa ama-Chambers we-Hyperbaric

Amakamelo angama-Rectangular Hyperbaric

Amakamelo we-Hyperbaric Modular Rectangular

Igama Product

Ama-Monoplace Hyperbaric Chambers 32 "kuya ku-40" Multiplace Hyperbaric Chambers 60 "to 96"

I-IIb I-Rectangular Hyperbaric Chambers 6 ukuya kwezi-10 izihlalo IIb

Ama-Modular Rectangular Hyperbaric Chambers izihlalo ezi-2 ukuya kwezi-12

IIb

ITekna Manufacturing Private Limited C19, Industrial Estate, Guindy, Chennai - 600 032, India

Omele i-EU

OBELIS SA, Bd. IGeneral Wahis, 53 1030 Brussels, eBelgium.

Uhlu oluphelele lwamadivayisi lufakwa kuMzimba Owazisiwe

Amasayithi ambozwe yilesi sitifiketi
Ikheli Legama Lesayithi

UMZIMBA OZISISIWE: DNV GL PRESAFE AS, Veritasveien 3, N-1363 Høvik, Norway - Inombolo Yebhizinisi Elibhalisiwe: NO 997 067 401 MVA.

I-MSD-CO-078-A Rev 0.0 Ikhasi 2 kwe-3

Inombolo Yesitifiketi.

10000322014-PA-NA-IND PRJC-581415-2018-PRC-IND

Imibandela

27 May 2020

Isitifiketi singaphansi kwemigomo nemibandela elandelayo:

•  Noma yimuphi umkhiqizi (bheka u-2001/95 / EC ukuthola incazelo eqondile) unesibopho somonakalo odalwe yisici esikuye

  umkhiqizo (imikhiqizo), ngokuyalelwa ngu-85/374 / EEC, njengoba uchitshiyelwe, maqondana nesikweletu esingalungile

  Imikhiqizo.

•  Isitifiketi sisebenza kuphela emikhiqizweni kanye / noma endaweni yokukhiqiza ebhalwe ngenhla.

•  Umkhiqizi uzofeza izibopho ezivela ohlelweni lwekhwalithi njengoba kuvunyelwe futhi kugcinwa

  ukuze ihlale yanele futhi isebenza kahle.

•  UMenzi uzokwazisa i-Presafe nganoma yikuphi ukuvuselelwa okuhlosiwe kohlelo lwekhwalithi kanye nentando ye-Presafe

  hlola izinguquko bese unquma ukuthi isitifiketi sihlala sisebenza yini.

• Aud Kuzobanjwa ukuhlolwa kwamabhuku ngezikhathi ezithile, ukuze kuqinisekiswe ukuthi uMenzi ugcina futhi asebenzise ifayili le-

  uhlelo lwekhwalithi. I-Presafe iyaligodla ilungelo, endaweni ethile noma ngokususelwa, lokuvakasha okungamenyezelwanga.

  Okulandelayo kungenza lesi Sitifiketi singasebenzi:  Izinguquko ohlelweni lwekhwalithi ezithinta ukukhiqizwa.
  Aud Ukuhlolwa kwezikhathi ezithile okungabanjwanga ewindini lesikhathi esivunyelwe.

  Isimemezelo se-Conformity nokumakwa komkhiqizo

  Lapho uhlangana nemigomo nemibandela engenhla, umkhiqizi angaqamba isimemezelo se-EC sokuhambisana futhi anamathisele ngokusemthethweni uphawu lwe-CE olulandelwa inombolo kamazisi yoMzimba owazisiwe we-Presafe.

  Ukuphela Kwesitifiketi

UMZIMBA OZISISIWE: DNV GL PRESAFE AS, Veritasveien 3, N-1363 Høvik, Norway - Inombolo Yebhizinisi Elibhalisiwe: NO 997 067 401 MVA.

I-MSD-CO-078-A Rev 0.0 Ikhasi 3 kwe-3