Tekna Manufacturing Celebrates Having Entire Line of Hyperbaric Chambers now CE Certified Under the Medical Device Directive
Hyperbaric Chambers from Tekna Manufacturing are now recognized in the EU as Certified Medical Devices. This is a step above most of the company’s competitors, who do not meet these high quality standards and are not legally permitted to market their devices for medical use.
Tampa, FL (PRUnderground) September 16th, 2020
The medical and health enthusiast world’s interest surrounding hyperbaric chambers for their use in treating non-healing wounds and a wide range of other conditions is on the rise. Hyperbaric chambers are a non-invasive way to pressurize patients up to two or three times normal atmospheric pressure while breathing oxygen. A selection of hyperbaric chambers is offered to meet a diverse range of needs, including (for businesses and caretakers) treating single patients or multiple patients at one time. Leading the way with their expertise in hyperbaric technology is Tekna Manufacturing Private Limited.. In exciting industry news, Tekna recently announced that the company has received their CE Certification MDD (under the Medical Device Directive) for its entire range of hyperbaric chambers, allowing them to legally market the devices as a class IIb medical devices in the European Union. The certification took a full two years to obtain and is a testament to the devotion Tekna has to quality manufacturing and delivering the best and most reliable devices possible.
“We have been marketing our products since the early 2000’s and helped pioneer hyperbarics in the USA,” commented Todd Janca, Founder and Head of Engineering and New Product Development of Tekna Manufacturing Pvt. Ltd. “The CE certification adds to the list of certifications our India operations have received, helps expand our global reach, and validates the safety and quality of our products.”
Sriram Narasimhan, Director of Tekna Manufacturing Pvt. Ltd., is equally enthusiastic about the new certification: “Though a common therapy in the United States, awareness of hyperbaric oxygen therapy (HBOT) is only just starting to grow in the rest of the world. Some items of interest bringing attention to the field are multiple studies showing the efficacy of HBOT in treating patients infected by COVID-19. With the CE certification we can enter various markets in and out of the EU. I’m glad we will be contributing to the spread of this technology.”
Tekna Manufacturing Pvt. Ltd. hopes their certification will enable them to stand out from their uncertified competitors, who often market low quality knockoffs that are unable to obtain the CE Certification under the Medical Device Directive. These merchants are not legally allowed to label their Hyperbaric Oxygen Therapy Chambers as medical devices and often use lower pressures to circumvent the regulations, which, however make them ineffective.
According to the company, Tekna received their US FDA clearance in 1999 and have been selling their products across the US since. In 2016, Tekna Manufacturing Pvt. Ltd. (India) was formed to increase the global reach of their products and provide timely service to customers across the world. The India facility is registered with the FDA, is certified to ISO 13485, and was among the first to receive MDSAP. It also received its UL listing and CB certification for their products in 2019.
Experts have responded passionately to Tekna’s Hyperbaric Oxygen Therapy Chambers.
Dr. Tyler Sexton, Vice President of the American College of Hyperbaric Medicine, who has been treating patients with hyperbaric therapy since the nineties and also offers multiple training programs for Hyperbaric Specialists, said in a five-star review, “We have been using Tekna hyperbaric chambers for a very long time. They are the best at what they do. I have treated thousands of patients with their hyperbaric chambers and have found them to be the best and safest chambers available on the [market]. [Now physicians] across Europe [and the US] can access Tekna hyperbaric chambers for implementing HBOT in their practice. I wish all success to the Tekna team in gaining a global market share.”
For more information visit https://hyperbaric-chamber.com.
About Tekna Manufacturing
Tekna is the Leading Manufacturer of Monoplace and Multiplace Hyperbaric Chambers for Hyperbaric Oxygen Therapy.