ISO 13485 2016 MDSAP CertificateDownload CERTIFICATE OF REGISTRATION TEKNA Manufacturing Pvt. Ltd. C-19, Industrial Estate, Guindy Chennai, Tamil Nadu 600032 INDIA UL Medical Regulatory Services of UL LLC®(UL) issues this certificate to the Firm named above, after auditing the Firm’s quality management system and finding it in conformance per the defined scope with respect to: ISO 13485:2016 with additional regulatory requirements listed on final page of this certificate. The design, manufacture, service and installation of hyperbaric chambers. Authorized by Michael J. Windler, P.E. Manager of Global Regulatory Service Distinguished Member of the Technical Staff UL Life and Health SciencesUL LLC Check Certificate Status: here REPs Facility ID: File Number Certificate Number Initial Issue Date A28843 3017.200413 April 13, 2020 Cycle Start Date Effective Date Expiry Date April 13, 2020 April 13, 2020 April 12, 2023 This quality system registration is included in UL’s Directory of Registered Firms and applies to the provision of goods and/or services as specified in the scope of registration from the address(es) shown above. By issuance of this certificate the firm represents that it will maintain its registration in accordance with the applicable requirements. This certificate is not transferable and remains the property of UL Medical and Regulatory Services of UL LLC. Certificates may be verified by visiting the Online Certifications Directory on UL.com. 00-MB-F0867 Issue 1.0 Page 1 of 2 UL Medical and Regulatory Services UL, LLC is an MDSAP Recognized Auditing Organization UL LLC 333 Pfingsten Road Northbrook, IL 60062-2096 USA UL and the UL logo are trademarks of Underwriters Laboratories Inc. © 2011. CERTIFICATE OF REGISTRATION TEKNA Manufacturing Pvt. Ltd. C-19, Industrial Estate, Guindy Chennai, Tamil Nadu 600032 INDIA Additional Regulatory Requirements REPs Facility ID: Australia:– Therapeutic Goods (Medical Devices) Regulations, 2002, Schedule 3 Part 1 (excluding Part 1.6) – Full Quality Assurance Procedure Brazil:– RDC ANVISA n. 16/2013 – RDC ANVISA n. 23/2012 – RDC ANVISA n. 67/2009 Canada:– Medical Devices Regulations – Part 1- SOR 98/282 Japan:– MHLW Ministerial Ordinance 169, Article 4 to Article 68 – PMD Act (,as applicable) United States: – 21 CFR 820 – 21 CFR 803 – 21 CFR 806 – 21 CFR 807 – Subparts A to D – 21 CFR 821 (where applicable) File Number Certificate Number Initial Issue Date A28843 3017.200413 April 13, 2020 Cycle Start Date Effective Date Expiry Date April 13, 2020 April 13, 2020 April 12, 2023 This quality system registration is included in UL’s Directory of Registered Firms and applies to the provision of goods and/or services as specified in the scope of registration from the address(es) shown above. By issuance of this certificate the firm represents that it will maintain its registration in accordance with the applicable requirements. This certificate is not transferable and remains the property of UL Medical and Regulatory Services of UL LLC. Certificates may be verified by visiting the Online Certifications Directory on UL.com. 00-MB-F0867 Issue 1.0 Page 2 of 2 UL Medical and Regulatory Services UL, LLC is an MDSAP Recognized Auditing Organization UL LLC 333 Pfingsten Road Northbrook, IL 60062-2096 USA UL and the UL logo are trademarks of Underwriters Laboratories Inc. © 2011. #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; } The Hybrid 4000 is the nicest Monoplace Chamber I have ever seen. Susan M.Hybrid 4000 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 The Tekna Chamber is operator friendly and has all the safety bells and whistles. Hugo – Chamber Operator 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 In the Tekna Chamber, our patients consistently comment how comfortable their dives are. Hugo – Chamber Operator The patients think the Tekna Chamber looks cool and they love the roominess. Hugo – Chamber Operator All of our patients love the Tekna chamber. It is so comfortable and roomy. Dr.Bill L.7200 DL The Tekna 4000 is incredibly easy to use. Learning how to use it took no effort at all. Very nice! Dr. A. HillHybrid 4000 We have been extremely pleased with the quality, workmanship, and reliability of our two Model 6000 Multiplace Chambers. Steven Meress – Midwest Hyperbarics6000 Our chamber was built and installed in 2002. It’s a workhorse. We’ve never had any problems. Jay – Owner – Director of Operations 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 Not you’r typical clunky chamber. Everything about the Tekna 7200 says high end medical equipment. Dr. Matthews7200 DL { "@context": "http://schema.org", "@type": "Product", "name": "Tekna Hyperbaric Chambers", "review": [ { "@type": "Review", "reviewBody": "The Hybrid 4000 is the nicest Monoplace Chamber I have ever seen. ", "author": { "@type": "Person", "name": "Susan M." }, "datePublished": "2017-12-07", "reviewRating": { "@type": "Rating", "ratingValue": "5", "bestRating": "5", "worstRating": "0" } }, { "@type": "Review", "reviewBody": "Our chamber is unstoppable. It’s in it’s 15th year of operation, and we’ve never had a down day.", "author": { "@type": "Person", "name": "Jay – Owner – Director of Operations" }, "datePublished": "2017-12-23", "reviewRating": { "@type": "Rating", "ratingValue": "5", "bestRating": "5", "worstRating": "0" } }, { "@type": "Review", "reviewBody": " Our Hyperbaric Chamber is fantastic! Better than we had hoped for!", "author": { "@type": "Person", "name": "Dr Thomas" }, "datePublished": "2017-12-06", "reviewRating": { "@type": "Rating", "ratingValue": "5", "bestRating": "5", "worstRating": "0" } }, { "@type": "Review", "reviewBody": "The Tekna Chamber is operator friendly and has all the safety bells and whistles.", "author": { "@type": "Person", "name": "Hugo – Chamber Operator" }, "datePublished": "2017-12-23", "reviewRating": { "@type": "Rating", "ratingValue": "5", "bestRating": "5", "worstRating": "0" } }, { "@type": "Review", "reviewBody": "The six person Multiplace system that you build for us in 2009 continues to be reliable and cost effective to operate.", "author": { "@type": "Person", "name": "Roy Schmidt – TN Hyperbaric Centers" }, "datePublished": "2017-12-23", "reviewRating": { "@type": "Rating", "ratingValue": "5", "bestRating": "5", "worstRating": "0" } }, { "@type": "Review", "reviewBody": "In the Tekna Chamber, our patients consistently comment how comfortable their dives are.", "author": { "@type": "Person", "name": "Hugo – Chamber Operator" }, "datePublished": "2017-12-23", "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": " All of our patients love the Tekna chamber. It is so comfortable and roomy.", "author": { "@type": "Person", "name": "Dr.Bill L." }, "datePublished": "2017-12-06", "reviewRating": { "@type": "Rating", "ratingValue": "5", "bestRating": "5", "worstRating": "0" } }, { "@type": "Review", "reviewBody": "The Tekna 4000 is incredibly easy to use. Learning how to use it took no effort at all. Very nice!", "author": { "@type": "Person", "name": "Dr. A. Hill" }, "datePublished": "2017-12-07", "reviewRating": { "@type": "Rating", "ratingValue": "5", "bestRating": "5", "worstRating": "0" } }, { "@type": "Review", "reviewBody": "We have been extremely pleased with the quality, workmanship, and reliability of our two Model 6000 Multiplace Chambers.", "author": { "@type": "Person", "name": "Steven Meress – Midwest Hyperbarics" }, "datePublished": "2017-12-23", "reviewRating": { "@type": "Rating", "ratingValue": "5", "bestRating": "5", "worstRating": "0" } }, { "@type": "Review", "reviewBody": "Our chamber was built and installed in 2002. It’s a workhorse. We’ve never had any problems.", "author": { "@type": "Person", "name": "Jay – Owner – Director of Operations" }, "datePublished": "2017-12-23", "reviewRating": { "@type": "Rating", "ratingValue": "5", "bestRating": "5", "worstRating": "0" } }, { "@type": "Review", "reviewBody": "Since our first order of three Monoplace Chambers in 2000 we have purchased over $1 Million dollars of HBOT Systems from Tekna.", "author": { "@type": "Person", "name": "John Richmond – Bioaeris" }, "datePublished": "2017-12-23", "reviewRating": { "@type": "Rating", "ratingValue": "5", "bestRating": "5", "worstRating": "0" } }, { "@type": "Review", "reviewBody": "Not you'r typical clunky chamber. Everything about the Tekna 7200 says high end medical equipment.", "author": { "@type": "Person", "name": "Dr. Matthews" }, "datePublished": "2017-12-07", "reviewRating": { "@type": "Rating", "ratingValue": "5", "bestRating": "5", "worstRating": "0" } } ], "aggregaterating": { "@type": "AggregateRating", "reviewCount": "13", "ratingCount": "13", "bestRating": "5", "worstRating": "0", "ratingValue": "5" }, "image": "https://hyperbaric-chamber.com/wp-content/uploads/MONOPLACE-HYPERBARIC-CHAMBER-MULTIPLACE-HYPERBARIC-CHAMBER-OEM-SALES.jpg", "description": "Tekna Hyperbaric Chambers", "url": "https://hyperbaric-chamber.com" } Need help selecting Your Perfect Chamber? Ask an Expert!