Defibtech Makes Its First International Shipment of Automated External Defibrillators (AEDs)
CE Marking approval, ISO 13485 certification pave the way for international growth.
GUILFORD, CONN. – May 25, 2004 – Defibtech today announced the international release of its Lifeline(TM) automated external defibrillators (AEDs), with its first major shipment to a customer in Italy. A leading innovator in the AED market, Defibtech recently paved the way for international sales by gaining CE Marking approval and ISO 13485 certification. Over the next several weeks and months, the company will continue its international rollout of the innovative Lifeline defibrillator to its distributors in Europe, South America, the Middle East and Asia.
The CE Marking is recognized by member countries of the European Union, as well as a number of other countries in Latin America, South America and Asia. The ISO 13485 certification places Defibtech in full quality compliance with European Union (EU) Directives for Medical Devices in the design, production, sales and services for automated external defibrillators (AEDs) and accessories. The certification process included a full quality system audit by an approved Notified Body to the ISO 13485 standard (Quality systems - Medical devices).
Featuring industry-leading biphasic defibrillation technology, the Defibtech AED is the market's most affordable unit, with a single-unit list price of $1,495 in the United States. The device has received several awards, including an Excellence in Design Award in the medical category from Appliance Manufacturer magazine. Easy to use and portable, the Defibtech AED actually "talks" to the user, giving audible step-by-step instructions on how to give lifesaving defibrillation. The AED's bright coloring and award-winning design make it easy to find and operate quickly. Having the industry's longest operational battery life, the Defibtech AED is built to the durability standards of professional emergency personnel.
AEDs dramatically improve the chances of surviving sudden cardiac arrest (SCA), which causes the heart to become arrhythmic and stop pumping blood effectively. The majority of SCA victims receiving timely defibrillation survive; without it, fewer than 5 percent of SCA victims live. AEDs deliver a defibrillating electrical shock that restores the heart's rhythm to normal. More than 400,000 people die from SCA annually.
About Defibtech
Defibtech relentlessly pursues one goal: making the best automatic external defibrillators (AEDs) in the world at affordable prices. Defibtech designs and manufactures the FDA-cleared Lifeline™ and ReviveR™ brand AEDs and related accessories. Defibtech's products are sold through its network of distribution partners in the United States and around the world. Founded in 1999, Defibtech is headquartered in Guilford, Connecticut and manufactures all of its defibrillators in the United States in state-of-the-art ISO 13485:2003 certified facilities. For more information about Defibtech and its products, visit www.defibtech.com or call 1-866-DEFIB-4-U (1-866-333-4248).
Contact
Defibtech, LLC
Greg Slusser
Vice President, Sales & Marketing
866-333-5641
greg@defibtech.com
or Defibtech Sales:
866-333-4248
sales@defibtech.com
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