CE MDD CertificateDownload EC CERTIFICATE Full Quality Assurance System Certificate No.: Project No.: Valid Until: 10000322014-PA-NA-IND PRJC-581415-2018-PRC-IND This is to certify that the quality system of: 27 May 2024 Tekna Manufacturing Private Limited C19, Industrial Estate, Guindy, Chennai – 600 032, India.For design, production and final product inspection/testing of: HYPERBARIC CHAMBERS Has been assessed with respect to: THE CONFORMITY ASSESSMENT PROCEDURE DESCRIBED IN ANNEX II EXCLUDING SECTION 4 OF COUNCIL DIRECTIVE 93/42/EEC ON MEDICAL DEVICES, AS AMENDED and found to comply. Further details of the product(s) and conditions for certification are given overleaf. Place and date: Høvik, 08 July 2020 For: DNV GL PRESAFE AS Notified Body No.: 2460 ______________________________________________________________________________ Mariann Jeremiassen The certificate is digitally verified by blockchain technology. For more info, see www.dnvgl.com/assurance/certificates-in-the- blockchain.html PROD 021 Notice: The Certificate is subject to terms and conditions as set out in the Certification Agreement. Failure to comply may render this Certificate invalid. NOTIFIED BODY: DNV GL PRESAFE AS, Veritasveien 3, N-1363 Høvik, Norway – Registered Enterprise No: NO 997 067 401 MVA . MSD-CO-078-A Rev 0.0 Page 1 of 3 Certificate No.: Project No.: Valid Until: 10000322014-PA-NA-IND PRJC-581415-2018-PRC-IND Jurisdiction 27 May 2020 Application of Council Directive 93/42/EEC of 14 June 1993, adopted as “Forskrift om Medisinsk Utstyr” by the Norwegian Ministry of Health and Care Services. Certificate history: Revision Description 0.0 Original Certificate Products covered by this Certificate: Issue Date 2020-07-08 Class IIb Product Description Monoplace Hyperbaric Chambers Multiplace Hyperbaric Chambers Rectangular Hyperbaric Chambers Modular Rectangular Hyperbaric Chambers Product Name Monoplace Hyperbaric Chambers 32” to 40” Multiplace Hyperbaric Chambers 60” to 96” IIb Rectangular Hyperbaric Chambers 6 to 10 seats IIb Modular Rectangular Hyperbaric Chambers 2 to 12 seats IIb Tekna Manufacturing Private Limited C19, Industrial Estate, Guindy, Chennai – 600 032, India EU Representative OBELIS S.A, Bd. General Wahis, 53 1030 Brussels, Belgium. The complete list of devices is filed with the Notified Body Sites covered by this certificateSite Name Address NOTIFIED BODY: DNV GL PRESAFE AS, Veritasveien 3, N-1363 Høvik, Norway – Registered Enterprise No: NO 997 067 401 MVA . MSD-CO-078-A Rev 0.0 Page 2 of 3 Certificate No.: Project No.: Valid Until: 10000322014-PA-NA-IND PRJC-581415-2018-PRC-IND Terms and conditions 27 May 2020 The certificate is subject to the following terms and conditions: Any producer (see 2001/95/EC for a precise definition) is liable for damage caused by a defect in his product(s), in accordance with directive 85/374/EEC, as amended, concerning liability of defective products. The certificate is only valid for the products and/or manufacturing premises listed above. The Manufacturer shall fulfil the obligations arising out of the quality system as approved and uphold it so that it remains adequate and efficient. The Manufacturer shall inform Presafe of any intended updating of the quality system and Presafe will assess the changes and decide if the certificate remains valid. Periodical audits will be held, in order to verify that the Manufacturer maintains and applies the quality system. Presafe reserves the right, on a spot basis or based on suspicion, to pay unannounced visits. The following may render this Certificate invalid: Changes in the quality system affecting production. Periodical audits not held within the allowed time window. Conformity declaration and marking of product When meeting with the terms and conditions above, the producer may draw up an EC declaration of conformity and legally affix the CE mark followed by the Notified Body identification number of Presafe. End of Certificate NOTIFIED BODY: DNV GL PRESAFE AS, Veritasveien 3, N-1363 Høvik, Norway – Registered Enterprise No: NO 997 067 401 MVA . MSD-CO-078-A Rev 0.0 Page 3 of 3 Need help selecting Your Perfect Chamber? Ask an Expert! #ttshowcase_0 .tt_theme_speech .ttshowcase_rl_quote_sided .ttshowcase_rl_quote, #ttshowcase_0 .tt_theme_speech .ttshowcase_rl_quote_block .ttshowcase_rl_quote, #ttshowcase_0 .tt_theme_speech .ttshowcase_rl_quote_sided .ttshowcase_rl_quote a, #ttshowcase_0 .tt_theme_speech .ttshowcase_rl_quote_block .ttshowcase_rl_quote a { background:#f5f5f5; color:#333333; }#ttshowcase_0 .tt_theme_speech .ttshowcase_rl_quote_block .ttshowcase_rl_quote:after, #ttshowcase_0 .tt_theme_speech .tt_quote_info-below .ttshowcase_rl_quote:after, #ttshowcase_0 .tt_theme_speech .tt_quote_info-above .ttshowcase_rl_quote:after { border-color: #f5f5f5 transparent; }#ttshowcase_0 .tt_theme_speech .ttshowcase_rl_quote_sided .ttshowcase_rl_quote:after { border-color: transparent #f5f5f5; }#ttshowcase_0 .tt_theme_speech .tt_info-left, #ttshowcase_0 .tt_theme_speech .tt_info-right, { }.ttshowcase_rl_title { color: white; font-size: 14px; } .ttshowcase_rl_subtitle { color: white; } .ttshowcase_rl_subtitle a:link { color: white; } .ttshowcase_rl_subtitle a:visited { color: white; } .ttshowcase_rl_subtitle a:before { color: white; } .ttshowcase_rl_subtitle a:hover { color: red; } .ttshowcase_rl_quote { font-size: 16px; font-weight: bold; } Our chamber is unstoppable. It’s in it’s 15th year of operation, and we’ve never had a down day. Jay – Owner – Director of Operations Our Hyperbaric Chamber is fantastic! Better than we had hoped for! Dr ThomasHybrid 4000 Since our first order of three Monoplace Chambers in 2000 we have purchased over $1 Million dollars of HBOT Systems from Tekna. John Richmond – BioaerisHybrid 3200 In the Tekna Chamber, our patients consistently comment how comfortable their dives are. Hugo – Chamber Operator Our chamber was built and installed in 2002. It’s a workhorse. We’ve never had any problems. Jay – Owner – Director of Operations The six person Multiplace system that you build for us in 2009 continues to be reliable and cost effective to operate. Roy Schmidt – TN Hyperbaric Centers6000 The Hybrid 4000 is the nicest Monoplace Chamber I have ever seen. Susan M.Hybrid 4000 The patients think the Tekna Chamber looks cool and they love the roominess. Hugo – Chamber Operator Not you’r typical clunky chamber. Everything about the Tekna 7200 says high end medical equipment. Dr. Matthews7200 DL The Tekna Chamber is operator friendly and has all the safety bells and whistles. Hugo – Chamber Operator We have been extremely pleased with the quality, workmanship, and reliability of our two Model 6000 Multiplace Chambers. Steven Meress – Midwest Hyperbarics6000 The Tekna 4000 is incredibly easy to use. Learning how to use it took no effort at all. Very nice! Dr. A. HillHybrid 4000 All of our patients love the Tekna chamber. It is so comfortable and roomy. Dr.Bill L.7200 DL { "@context": "http://schema.org", "@type": "Product", "name": "Tekna Hyperbaric Chambers", "review": [ { "@type": "Review", "reviewBody": "Our chamber is unstoppable. 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", "author": { "@type": "Person", "name": "Susan M." }, "datePublished": "2017-12-07", "reviewRating": { "@type": "Rating", "ratingValue": "5", "bestRating": "5", "worstRating": "0" } }, { "@type": "Review", "reviewBody": "The patients think the Tekna Chamber looks cool and they love the roominess.", "author": { "@type": "Person", "name": "Hugo – Chamber Operator" }, "datePublished": "2017-12-23", "reviewRating": { "@type": "Rating", "ratingValue": "5", "bestRating": "5", "worstRating": "0" } }, { "@type": "Review", "reviewBody": "Not you'r typical clunky chamber. 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