Setifikeiti sa MDD

KERETE EA EC

Sisteme e Felletseng ea Netefatso ea Boleng

Nomoro ea setifikeiti.: Nomoro ea Morero: E sebetsa ho fihlela:

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

Sena ke ho netefatsa hore sistimi ea boleng ba:

27 May 2024

Tekna Manufacturing Private Limited

C19, Industrial Estate, Guindy, Chennai - 600 032, India.
Bakeng sa moralo, tlhahiso le tlhahlobo ea ho qetela ea sehlahisoa / tlhahlobo ea:

LITLHAKU TSE KHOLO

E se e hlahlobiloe mabapi le:

MOKHATLO OA TEKOLO EA BOPHELLO O HLALOSITSOENG SEHOPHELONG II II Kantle ho Karolo ea 4 ea Tataiso ea Lekhotla 93/42 / EEC MABAPI LE LITLHAKU TSA MOKHOA

'me a fumanoa a latela.

Lintlha tse ling tsa sehlahisoa (se) le maemo a netefatso a fanoa ka lekhasi le fetang.

Sebaka le letsatsi:

Høvik, 08 Phupu 2020

Bakeng sa:

DNV GL PRESAFE JOALOKAHA 'mele o tsebisitsoeng ea: 2460

______________________________________________________________________________

Mariann Jeremiassen

Setifikeiti se netefalitsoe ka dijithale ke theknoloji ea blockchain. Ho fumana lintlha tse ling, bona www.dnvgl.com/assurance/certificates-in-the- blockchain.html

PROD 021

Tsebiso: Setifikeiti se na le lipehelo le lipehelo tse boletsoeng ho Tumellano ea Setifikeiti. Ho sitoa ho latela ho ka etsa hore Setifikeiti sena se se sebetse.

BODI E TSEBISOANG: DNV GL PRESAFE AS, Veritasveien 3, N-1363 Høvik, Norway - Nomoro ea Khoebo e ngolisitsoeng: NO 997 067 401 MVA.

MSD-CO-078-A Rev 0.0 Leqephe la 1 la 3

Nomoro ea setifikeiti.: Nomoro ea Morero: E sebetsa ho fihlela:

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

matla

27 May 2020

Ts'ebeliso ea Directive ea Lekhotla 93/42 / EEC ea la 14 Phuptjane 1993, e amohetsoeng e le "Forskrift om Medisinsk Utstyr" ke Lefapha la Bophelo le Litšebeletso tsa Tlhokomelo la Norway.

Nalane ea setifikeiti:

Tlhaloso ea Nchafatso

Lihlahisoa tsa Setifikeiti sa Pele tse koahetsoeng ke Setifikeiti sena:

Letsatsi la phatlalatso

2020-07-08

Class

IIb

Tlhaloso ea Sehlahisoa

Monoplace Hyperbaric Chambers

Multiplace Chambers Hyperbaric

Likamore tse likhutlo li 'ne tsa Hyperbaric

Likamore tsa Hyperbaric tsa Modular Rectangular

Name Product

Monoplace Hyperbaric Chambers 32 "ho 40" Multiplace Hyperbaric Chambers 60 "ho isa ho 96"

IIb likhutlo tse 'ne tsa Hyperbaric Chambers litulo tse 6 ho isa ho tse 10 IIb

Modular Rectangular Hyperbaric Chambers litulo tse 2 ho isa ho tse 12

IIb

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

Moemeli oa EU

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

Lenane le felletseng la lisebelisoa le kentsoe ho 'mele o tsebisitsoeng

Libaka tse koahetsoeng ke setifikeiti sena
Aterese ea Lebitso la Sebaka

BODI E TSEBISOANG: DNV GL PRESAFE AS, Veritasveien 3, N-1363 Høvik, Norway - Nomoro ea Khoebo e ngolisitsoeng: NO 997 067 401 MVA.

MSD-CO-078-A Rev 0.0 Leqephe la 2 la 3

Nomoro ea setifikeiti.: Nomoro ea Morero: E sebetsa ho fihlela:

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

Lipallo le lipehelo

27 May 2020

Setifikeiti se na le lipehelo le lipehelo tse latelang:

  • Mohlahisi e mong le e mong (bona 2001/95 / EC bakeng sa tlhaloso e nepahetseng) o ikarabella bakeng sa tšenyo e bakiloeng ke sekoli ho eena

    sehlahisoa (s), ho latela taelo ea 85/374 / EEC, joalo ka ha e ntlafalitsoe, mabapi le mokoloto oa phoso

    lihlahisoa.

  •  Setifikeiti se sebetsa feela bakeng sa lihlahisoa le / kapa moaho oa tlhahiso o thathamisitsoeng kaholimo.

  • Moetsi o tla phethahatsa boitlamo bo hlahang ho sistimi ea boleng joalo ka ha e amohetsoe le ho tšehetsoa

    e le hore e lule e lekana ebile e sebetsa hantle.

  • Moetsi o tla tsebisa Presafe ka ntlafatso efe kapa efe e reriloeng ea sistimi ea boleng le thato ea Presafe

    lekola liphetoho mme o etse qeto ea hore na setifikeiti se lula se sebetsa.

  • Aud Litlhahlobo tsa nako le nako li tla ts'oaroa, molemong oa ho netefatsa hore Moetsi o boloka le ho sebelisa

    boleng tsamaiso. Presafe e boloka tokelo, sebakeng kapa e ipapisitse le lipelaelo, tsa ho etela batho ba sa tsebisoa.

    Tse latelang li ka etsa hore Setifikeiti sena se se sebetse:  Liphetoho tsamaisong ea boleng e amang tlhahiso.
    Aud Litlhahlobo tsa nako le nako tse sa tšoareloeng nakong ea nako e lumelletsoeng.

    Phatlalatso ea tumellano le ho tšoaea sehlahisoa

    Ha a kopana le lipehelo le lipehelo tse kaholimo, mohlahisi a ka ngola phatlalatso ea EC ea tumellano mme a hlomathisa semolao lets'oao la CE mme a lateloa ke nomoro ea boitsebahatso ea 'mele e tsebisitsoeng ea Presafe.

    Qetellong ea Setifikeiti

BODI E TSEBISOANG: DNV GL PRESAFE AS, Veritasveien 3, N-1363 Høvik, Norway - Nomoro ea Khoebo e ngolisitsoeng: NO 997 067 401 MVA.

MSD-CO-078-A Rev 0.0 Leqephe la 3 la 3

U hloka thuso ho khetha Khetho ea Hao e Phethahetseng?