CERTIFICATE EC

ʻŌnaehana hōʻoia piha piha

Palapala No.: No Papahana: ʻIke a hiki i:

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

E hōʻoia kēia i ka ʻōnaehana maikaʻi o:

27 May 2024

ʻO Limited Tekna Manufacturing Private Limited

C19, Waiwai Hana, Guindy, Chennai - 600 032, ʻInia.
No ka hoʻolālā, hana a me ka nānā hope huahana o:

KEKAHI HYPERBARIC

Ua loiloi ʻia me ka mahalo iā:

NĀ KAUOHA MAKAHI MAKAHI I NĀ MEA I KAHI ANNEX II E WAIWAI ANA I KA ʻĀINA 4 O KE KĀLĀWAI DIRECTIVE 93/42 / EEC NO NĀ LĀKAI LOA, I KAHI I HUI

a loaʻa e hoʻokō.

ʻO nā kikoʻī hou aʻe o ka huahana (s) a me nā kūlana no ka hōʻoia ʻana i hāʻawi ʻia ma overleaf.

Kahi a me ka lā:

ʻO Høvik, 08 Iulai 2020

no ka:

ʻO DNV GL PRESAFE KAHI Kākau ʻia No.: 2460

______________________________________________________________________________

ʻO Mariann Ierassen

Hōʻoia ʻia ka palapala e ka ʻenehana blockchain. No ka ʻike hou aku, e ʻike www.dnvgl.com/assurance/cert Certificate-in-the- blockchain.html

PROD 021

Hoʻolaha: Aia ka palapala i nā huaʻōlelo a me nā kūlana e like me ka mea i hōʻike ʻia i loko o ka ʻaelike hōʻoia. ʻO ka hoʻokō ʻole e hoʻoliʻiliʻi paha kēia palapala.

KE KINO NUI: DNV GL PRESAFE AS, Veritasveien 3, N-1363 Høvik, Nolewai - ʻOihana ʻĀina Kakau: NO 997 067 401 MVA.

MSD-CO-078-A Rev 0.0 ʻAoʻao 1 o 3

Palapala No.: No Papahana: ʻIke a hiki i:

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

Ke mana hoʻokolokolo

27 May 2020

Noi o ka ʻaha aʻoaʻo kuhikuhi 93/42 / EEC o ka 14 Iune 1993, i lawe ʻia ma ke ʻano he "Forskrift om Medisinsk Utstyr" na ke Kuhina Nui o nā lawelawe olakino a me nā lawelawe mālama.

Mōʻaukala palapala:

Hōʻike Hoʻohou

0.0 Nā huahana palapala hōʻoia i uhi ʻia e kēia palapala:

Laka hopena

2020-07-08

papa

IIb

Product Description

ʻO Monoplace Hyperbaric Chambers

ʻO nā Mokuna Hou'Ouaua

Nā Keena Hyperbaric Rectangular

Nā Chambers Hyperbaric Modular Rectangular

Product Name

ʻO Monoplace Hyperbaric Chambers 32 "a 40" Multiplace Hyperbaric Chambers 60 "a 96"

IIb Rectangular Hyperbaric Chambers 6 a 10 noho IIb

Nā Chambers Hyperbaric Modular Rectangular 2 a 12 mau noho

IIb

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

Lunamakaainana EU

OBELIS SA, Bd. ʻO General Wahis, 53 1030 Palukela, Pelekiuma.

Waiho ʻia ka papa inoa piha o nā hāmeʻa me ka Notified Body

Nā pūnaewele i uhi ʻia e kēia palapala
Wahi inoa inoa pūnaewele

KE KINO NUI: DNV GL PRESAFE AS, Veritasveien 3, N-1363 Høvik, Nolewai - ʻOihana ʻĀina Kakau: NO 997 067 401 MVA.

MSD-CO-078-A Rev 0.0 ʻAoʻao 2 o 3

Palapala No.: No Papahana: ʻIke a hiki i:

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

Kumu, a me na kumu

27 May 2020

Aia ka palapala i kēia mau huaʻōlelo a me nā kūlana:

•  ʻO kēlā me kēia mea hana (ʻike i ka 2001/95 / EC no ka wehewehe kikoʻī) kuleana ia no ka poino i hoʻokumu ʻia e kahi kīnā ʻole i kāna

  huahana (s), e like me ke kuhikuhi 85/374 / EEC, e like me ka mea i hoʻoponopono ʻia, e pili ana i ke kuleana o ka hemahema

  nā huahana.

•  Kūpono wale ka palapala hōʻoia no nā huahana a me / a i ʻole nā ​​wahi hana i helu ʻia ma luna.

• Fulfill E hoʻokō ka mea hana i nā kuleana e puka mai ana mai ka ʻōnaehana e like me ka mea i ʻae ʻia a mālama ʻia

  ia i mea e lawa ai ka lawa pono.

•  E hoʻomaopopo ka mea hana iā Presafe i kēlā me kēia mea e hoʻohou nei i ka ʻōnaehana maikaʻi a makemake ʻo Presafe

  Loiloi i nā loli a hoʻoholo inā paʻa ka palapala.

•  E mālama ʻia nā loiloi manawa, i mea e hōʻoia ai e mālama a pili ana ka mea hana

  ʻōnaehana maikaʻi. Mālama ʻo Presafe i ke kuleana, ma ke kahua a i ʻole pili i ka kānalua, e uku i nā kipa i hōʻike ʻole ʻia.

  Hiki i nā mea aʻe ke hoʻoilina i kēia palapala:  Nā loli i ka ʻōnaehana maikaʻi e hoʻopili ana i ka hana.
  Not ʻAʻole mālama ʻia nā loiloi wā ma loko o ka puka manawa i ʻae ʻia.

  Hoʻolaha kūlike a me ka māka ʻana o ka huahana

  Ke hui ʻana me nā huaʻōlelo a me nā kūlana ma luna, hiki i ka mea hana ke huki i kahi hoʻolaha EC no ka hana ʻana a kau i ke kānāwai i ka māka CE a ukali ʻia e ka helu hoʻomaopopo ʻia o Presafe.

  Pau o ka palapala

KE KINO NUI: DNV GL PRESAFE AS, Veritasveien 3, N-1363 Høvik, Nolewai - ʻOihana ʻĀina Kakau: NO 997 067 401 MVA.

MSD-CO-078-A Rev 0.0 ʻAoʻao 3 o 3