Defibtech Receives CE Marking and ISO-13485 Certification
GUILFORD, CT – February 11, 2004 – Defibtech, a leading innovator in the Automated External Defibrillation (AED) market, today announced that it has received approval to place the CE Marking on its devices.
The certification process included a full quality system audit by an approved Notified Body to the ISO 13485 standard (Quality systems - Medical devices). The CE Marking approval process certified that Defibtech is 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 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 Defibtech AED features industry leading biphasic defibrillation technology, self-testing capability, simple and intuitive user interface and voice prompts, longest operational battery life (up to 7 years), and a professional-grade, real-world rugged design. The Defibtech AED is also the value leader with a Manufacturer's Suggested Retail Price (MSRP) of $1,495. This price includes everything a customer needs to completely deploy this lifesaving solution, including the AED, defibrillation pads and a 5-year 125-shock battery pack.
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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