Satifiketi ya MDD

CHITSANZO CHA EC

Ndondomeko Yotsimikizika Yathunthu

No Chiphaso.: Project Nambala: Yoyambira Mpaka:

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

Izi ndikutsimikizira kuti mtundu wabwino wa:

27 May 2024

Mtengo wa magawo Tekna Manufacturing Private Limited

C19, Industrial Estate, Guindy, Chennai - 600 032, India.
Kwa kapangidwe, kapangidwe kake ndi kuyesa komaliza kwa kuyesa / kuyesa kwa:

MALO OGWIRITSA NTCHITO

Yayesedwa mokhudzana ndi:

NJIRA YOYESETSETSA KUKONDA KULIMBIKITSA NTCHITO YOFotokozedwa M'ndime Yachiwiri II KUPHUNZITSA CHIGAWO CHACHIWIRI CHA Bwalo La Malangizo 4/93 / EEC PADZIPHUNZITSO ZA MANKHWALA.

ndipo adapezeka kuti akutsatira.

Zambiri pazazogulitsazo komanso momwe zitsimikiziridwe zimaperekedwa.

Malo ndi tsiku:

Høvik, 08 Julayi 2020

Kwa:

DNV GL PRESAFE AS Thupi Lodziwitsidwa Na.: 2460

______________________________________________________________________________

Mariann Jeremiassen

Satifiketi imatsimikiziridwa ndi digito ndiukadaulo wa blockchain. Kuti mumve zambiri, onani www.dnvgl.com/assurance/certificates-in-the- blockchain.html

Njira 021

Chidziwitso: Satifiketiyo ikukwaniritsa mfundo ndi zofotokozedwa mu Pangano la Certification. Kulephera kutsatira izi kungapangitse kuti Chiphasochi chikhale chosavomerezeka.

THUPI LODZIWITSIDWA: DNV GL PRESAFE AS, Veritasveien 3, N-1363 Høvik, Norway - Nambala Yogulitsa Yolembetsa: NO 997 067 401 MVA.

MSD-CO-078-A Rev 0.0 Tsamba 1 pa 3

No Chiphaso.: Project Nambala: Yoyambira Mpaka:

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

Ulamuliro

27 May 2020

Kugwiritsa ntchito Council Directive 93/42 / EEC ya 14 June 1993, yotchedwa "Forskrift om Medisinsk Utstyr" ndi Unduna wa Zaumoyo ndi Ntchito Zosamalira ku Norway.

Mbiri ya satifiketi:

Kufotokozera Zosintha

0.0 Zomwe Zikalata Zoyambirira Zapangidwa ndi Satifiketi iyi:

Tsiku losindikiza

2020-07-08

Maphunziro

IIb

Mafotokozedwe Akatundu

Malo osungunuka a Hyperbaric Chambers

Lembani Multipericic Chambers

Makona Ozungulira Amakona Okwanira

Ma Modular Amakona Ozungulira a Hyperbaric Chambers

Name mankhwala

Monoplace Hyperbaric Chambers 32 "mpaka 40" Multiplace Hyperbaric Chambers 60 "mpaka 96"

IIb Amakona Ozungulira Hyperbaric Chambers 6 mpaka 10 mipando IIb

Modular Rectangular Hyperbaric Chambers 2 mpaka 12 mipando

IIb

Mtengo wa magawo Tekna Manufacturing Private Limited C19, Industrial Estate, Guindy, Chennai - 600 032, India

Woimira EU

OBELIS SA, Bd. General Wahis, 53 1030 Brussels, Belgium.

Mndandanda wathunthu wazida umasungidwa ku Thupi Lodziwitsidwa

Masamba omwe ali ndi satifiketi iyi
Adilesi Yapatsamba

THUPI LODZIWITSIDWA: DNV GL PRESAFE AS, Veritasveien 3, N-1363 Høvik, Norway - Nambala Yogulitsa Yolembetsa: NO 997 067 401 MVA.

MSD-CO-078-A Rev 0.0 Tsamba 2 pa 3

No Chiphaso.: Project Nambala: Yoyambira Mpaka:

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

Migwirizano ndi zokwaniritsa

27 May 2020

Satifiketi ili ndi mfundo zotsatirazi:

  • Producer Wopanga aliyense (onani 2001/95 / EC kuti mumve tanthauzo lenileni) amayenera kuwonongeka chifukwa cha chilema chake

    Zogulitsa, malinga ndi malangizo 85/374 / EEC, monga yasinthidwa, yokhudza zovuta zomwe zili ndi vuto

    mankhwala.

  •  Satifiketiyi ndi yovomerezeka pazinthu zomwe zatchulidwa pamwambapa.

  •  Wopanga azikwaniritsa zomwe zikuyenera kuchokera muntchito yoyenererayi malinga ndi kuvomerezedwa ndikusungidwa

    kotero kuti imakhalabe yokwanira komanso yothandiza.

  •  Wopanga amadziwitsa Presafe pazomwe akufuna kusintha pamachitidwe abwino ndi Presafe will

    kuwunika kusintha ndikusankha ngati satifiketiyo ikugwirabe ntchito.

  • Aud Kufufuza kwakanthawi kumachitika, kuti muwonetsetse kuti Wopanga amasunga ndikugwiritsa ntchito

    dongosolo labwino. Otetezedwa amakhala ndi ufuluwo, pamalo pomwepo kapena potengera kukayikirana, kukacheza maulendo osadziwika.

    Otsatirawa atha kupereka satifiketi iyi kukhala yosagwira:
    Aud Kufufuza kwakanthawi kosachitika mu nthawi yololedwa.

    Kukhazikitsa pamalingaliro ndi chizindikiro cha malonda

    Mukakumana ndi zomwe zanenedwa pamwambapa, wopanga akhoza kulemba chilengezo cha EC chofananira ndikulemba mwalamulo chizindikiritso cha CE ndikutsatiridwa ndi nambala Yodziwika Yodziwika ya Presafe.

    Kutha kwa Chiphaso

THUPI LODZIWITSIDWA: DNV GL PRESAFE AS, Veritasveien 3, N-1363 Høvik, Norway - Nambala Yogulitsa Yolembetsa: NO 997 067 401 MVA.

MSD-CO-078-A Rev 0.0 Tsamba 3 pa 3

Mukusowa chithandizo chosankha Malo Anu Opambana?