EC FAAMA TALAGA

Tulaga Atoa Inisiua Faiga

Tusi Faamaonia Nu.: Polokalama Nu: Faʻamaonia Seʻia:

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

Ole mea lea e faʻamaonia ai o le tulaga lelei o:

27 Me 2024

Tekna Gaosiga Tumaoti Limited

C19, Esetete Alamanuia, Guindy, Chennai - 600 032, Initia.
Mo le mamanu, gaosiga ma mulimuli asiasiga oloa / tofotofoina o:

FUAFUAGA FAʻAMASINO

Na iloiloina e tusa ma le:

O LE FUAFUAINA O GALUEGA FAʻAMATALAGA FAʻAMATALAGA I LE FAʻAMATALAGA II FAʻAIʻUINA O LE Vaega 4 O LE FONOTONI FAʻATONU 93/42 / EEC I FUAFUAʻI FUAFUAGA, PEI FUAFUA

ma ua maua e usitaʻi.

O loʻo iai isi faʻamatalaga o oloa (s) ma tuʻutuʻuga mo tusi pasi e faʻaaogaina tele.

Nofoaga ma le aso:

Høvik, 08 Iulai 2020

Mo:

DNV GL PRESAFE AS Faʻailoaina Tino Nu: 2460

______________________________________________________________________________

Mariann Ierassen

O le tusi faamaonia ua faʻamaonia faʻamaonia e poloka tekonolosi. Mo nisi faʻamatalaga, vaʻai i le www.dnvgl.com/assurance/certlets-in-the- blockchain.html

PROD 021

Faasilasilaga: O le Tusi Faamaonia e noatia i tuutuuga ma aiaiga e pei ona faataatia mai i le Tusi Faamaonia Maliega. O le le usitaʻi e ono le aoga ai lenei Tusi Faʻamaonia.

TINO FAʻAALIIA: DNV GL PRESAFE AS, Veritasveien 3, N-1363 Høvik, Nouei - Resitara Enterprise Nu: LEAI 997 067 401 MVA.

MSD-CO-078-A Rev 0.0 Itulau 1 o le 3

Tusi Faamaonia Nu.: Polokalama Nu: Faʻamaonia Seʻia:

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

Puleaga

27 Me 2020

Faʻaogaina o le Council Directive 93/42 / EEC o le 14 Iuni 1993, na avea ma "Forskrift om Medisinsk Utstyr" e le Norwegian Ministry of Health and Care Services.

Talafaʻasolopito tusi:

Faʻamatalaga Toe Faʻamatalaga

0.0 Original Certificate Products o loʻo ufiufi e lenei Tusi Faʻamaonia:

Mataupu Aso

2020-07-08

vasega

IIb

Faamatalaga oloa

Monoplace Hyperbaric Chambers

Faʻateleina potu ole Hyperbaric

Potu Tafatolu Hyperbaric

Potu Faʻataʻavaleina Modular Rectangular Hyperbaric

Igoa oloa

Monoplace Hyperbaric Chambers 32 "i le 40" Multiplace Hyperbaric Chambers 60 "i le 96"

IIb Rectangular Hyperbaric Chambers 6 i le 10 nofoa IIb

Modular Rectangular Hyperbaric Chambers 2 i le 12 nofoa

IIb

Tekna Oloa Gaosi Tumaoti Limited C19, Alamanuia Fale, Guindy, Chennai - 600 032, Initia

Sui a le EU

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

O le lisi atoa o masini ua faila i le Notified Body

Nofoaga ufiufi e lenei tusi faʻamaonia
Tuatusi igoa igoa

TINO FAʻAALIIA: DNV GL PRESAFE AS, Veritasveien 3, N-1363 Høvik, Nouei - Resitara Enterprise Nu: LEAI 997 067 401 MVA.

MSD-CO-078-A Rev 0.0 Itulau 2 o le 3

Tusi Faamaonia Nu.: Polokalama Nu: Faʻamaonia Seʻia:

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

Tuutuuga ma aiaiga

27 Me 2020

O le tusi faamaonia e noatia i le nei tuutuuga ma aiaiga:

•  Soʻo se tagata gaosi oloa (silasila i le 2001/95 / EC mo se faʻamatalaga saʻo) e noatia mo le faʻaleagaina na mafua mai i se faʻaletonu i lana

  oloa (s), ina ia tusa ai ma le faʻatonuga 85/374 / EEC, e pei ona teuteuina, e uiga i aitalafu o faaletonu

  Oloa.

•  O le tusi faʻamaonia e naʻo le aoga mo oloa ma / poʻo fale gaosi oloa lisi atu i luga.

•  E tatau i le gaosi oloa ona faʻataunuʻuina aitalafu e afua mai i le tulaga lelei e pei ona pasia ma lagolagoina

  ia ia tumau ona lava ma lelei.

•  E tatau i le gaosi oloa ona faʻailoa ia Presafe soʻo se faamoemoe e faʻafouina le lelei o le tino ma Presafe o le a

  iloilo suiga ma filifili pe tumau le tusi pasi.

•  O le a faia faʻavaitaimi suʻesuʻega, ina ia faʻamaonia ai o loʻo tausia ma faʻaogaina e le Kamupani

  faiga lelei. Presafe faasao le aia tatau, i luga o se avanoa tulaga pe faʻavae i luga o masalosaloga, e totogi le faʻailoaina asiasiga.

  O mea nei e ono le aoga ai lenei Tusi Faʻamaonia: Suiga i le tulaga lelei aʻafiaga aafia ai gaosiga.
   O suʻega faʻavaitaimi e le faia i totonu o faʻataga taimi faʻamalama.

  Tautinoga taʻutinoga ma faʻailogaina o oloa

  Pe a feiloaʻi ma tuʻutuʻuga ma aiaiga i luga atu, e mafai e le tagata gaosi ona tusia se EC faʻaaliga o le mulimulitaʻi ma faʻatulafono faʻapipiʻi le faailoga CE sosoʻo ai ma le Notified Tino faʻailoaina numera o Presafe.

  Faaiuga o le Tusi Faamaonia

TINO FAʻAALIIA: DNV GL PRESAFE AS, Veritasveien 3, N-1363 Høvik, Nouei - Resitara Enterprise Nu: LEAI 997 067 401 MVA.

MSD-CO-078-A Rev 0.0 Itulau 3 o le 3