EC akwụkwọ

Sistemụ Nlekọta Ogo zuru ezu

Akwụkwọ No.: No No.: Kwuru Ruo:

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

Nke a bụ iji gosi na usoro ịdị mma nke:

27 May 2024

Tekna n'ichepụta n'onwe Limited

C19, Industriallọ Ọrụ, Guindy, Chennai - 600 032, India.
Maka imewe, imepụta na nyocha ngwaahịa ikpeazụ / nnwale nke:

YLỌ HYPERBARIC

Enyochala maka:

AKWKWỌ AKWFKWỌ AKW CONKWỌ AHFRFTA KWURU NA ANNEX II KWURU NKEBI NKE 4 nke KWESUNR D KWES 93R 42 XNUMX/XNUMX / EEC NA Ngwaọrụ ọgwụ, ASEBERE

ma chọpụta ime.

A na-enye nkọwa zuru ezu banyere ngwaahịa (s) na ọnọdụ maka asambodo overleaf.

Ebe na ụbọchị:

Høvik, 08 Julaị 2020

Maka:

DNV GL PRESAFE AS Egosiri Isi No.: 2460

______________________________________________________________________________

Mariann Jeremiassen

Asambodo ahụ bụ teknụzụ site na teknụzụ blockcheni na - enyocha ya site na ntanetị. Maka ozi ndị ọzọ, lee www.dnvgl.com/assurance/certificates-in-the- blockchain.html

Ngwa 021

Mara: Asambodo ahụ dabere na usoro na ọnọdụ dị ka edepụtara na Nkwekọrịta Asambodo. Ọfụma ime ihe nwere ike ime ka Asambodo a ghara ịdị irè.

AHTA AH NOTR:: DNV GL PRESAFE AS, Veritasveien 3, N-1363 Høvik, Norway - Reglọ ọrụ edebanyere aha No: NO 997 067 401 MVA.

MSD-CO-078-A Rev 0.0 Peeji nke 1 nke 3

Akwụkwọ No.: No No.: Kwuru Ruo:

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

Ikike

27 May 2020

Itinye akwụkwọ nke Ntụziaka Council 93/42 / EEC nke 14 June 1993, nke ndị “Ministry of Health and Care Services” nke Norway kpọrọ “Forskrift om Medisinsk Utstyr”.

Akwụkwọ akụkọ ihe mere eme:

Ntughari nyocha

0.0 Ngwaahịa Asambodo mbụ nke Asambodo a:

Ụbọchị enyere

2020-07-08

klas

IIb

Product Description

Ụlọ Hyperbaric Monoplace

Ụlọ Hyperbaric dị iche iche

Lọ Hyperbaric akụkụ anọ

Hylọ Hyperbaric Module Modular

Product Name

Oplọ Hyperbaric Monoplace 32 "ruo 40" placelọ Hyperbaric Ọtụtụ Multi 60 "ruo 96"

Blọ Hyperbaric nke akụkụ anọ nke IIb nwere oche 6 ruo 10 oche IIb

Hylọ Hyperbaric Modular nwere akụkụ abụọ na oche 2

IIb

Tekna n'ichepụta nkeonwe C19, ụlọ ọrụ ụlọ ọrụ, Guindy, Chennai - 600 032, India

Onye nnọchi anya EU

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

A na-edebanye aha ndepụta nke ngwaọrụ zuru ezu na ahụ gị ekwuputara

Saịtị kpuchitere asambodo a
Adreesị Aha saịtị

AHTA AH NOTR:: DNV GL PRESAFE AS, Veritasveien 3, N-1363 Høvik, Norway - Reglọ ọrụ edebanyere aha No: NO 997 067 401 MVA.

MSD-CO-078-A Rev 0.0 Peeji nke 2 nke 3

Akwụkwọ No.: No No.: Kwuru Ruo:

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

Usoro na ọnọdụ

27 May 2020

The akwụkwọ bụ n'okpuru ndị na-esonụ usoro na ọnọdụ:

•  Onye nrụpụta ọ bụla (lee afọ 2001/95 / EC maka nkọwapụta ọ bụla) kwesiri ịda mba maka mmebi dị na ya.

  ngwaahịa (s), dabere na ntuziaka 85/374 / EEC, ka emeziri, gbasara ọrụ nke nkwarụ

  ngwaahịa.

• Asambodo ahụ dị irè maka ngwaahịa na / ma ọ bụ ụlọ nrụpụta edepụtara n'elu.

• Onye nrụpụta ga-arụ ọrụ dịịrị site na sistemụ ogo dị ka akwadoro ma kwado ya

  ya mere na ọ na-anọgide zuru oke na oru oma.

•  Onye nrụpụta ga-agwa Presafe nke mmelite ọ bụla echere maka usoro ịdị mma ya na Presafe ga

  chọpụta mgbanwe ma kpebie ma ọ bụrụ na akwụkwọ ahụ ka dị irè.

•  A ga-eme nyocha oge ụfọdụ, iji nyochaa na Onye nrụpụta na-ekwusi ike ma tinye ya

  mma usoro. Presafe nwere ikike, n'otu ebe ma ọ bụ dabere na enyo, ịkwụ ụgwọ nleta na-enweghị ọkwa.

  Ndị na-esonụ nwere ike ijikwa Asambodo a abaghị uru:  Mgbanwe na usoro ịdị mma na-emetụta mmepụta.
  Its A naghị eme nyocha oge ha oge na windo oge enyere.

  Nkwupụta nkwenye na akara nke ngwaahịa

  Mgbe ị na-ezute usoro na ọnọdụ dị n'elu, onye nrụpụta nwere ike wepụta nkwupụta EC nke kwekọrọ ma tinye iwu CE n'ụzọ iwu na akara ọkwa ọkwa ọkwa nke Presafe.

  Ọgwụgwụ nke Asambodo

AHTA AH NOTR:: DNV GL PRESAFE AS, Veritasveien 3, N-1363 Høvik, Norway - Reglọ ọrụ edebanyere aha No: NO 997 067 401 MVA.

MSD-CO-078-A Rev 0.0 Peeji nke 3 nke 3