August 22, 2012
Toronto, Canada. (August 22, 2012) Benetech Inc. is a software development company that creates and markets tools for use in prenatal screening. Its flagship product, Benetech PRA is used daily by hundreds of leading hospitals and labs around the world to screen millions of pregnancies each year for chromosomal anomalies.
Benetech announced today that it has received CE Mark approval for its Benetech PRA software product for prenatal screening. Full information on the certificate is as follows:
EC Certificate – Full Quality Assurance System Approval Certificate
Annex IV, section 3 of Council Directive 98/79/EC on In Vitro Diagnostic Medical Devices
Scope of Certificate:
The design and development, manufacture and servicing of software used for the calculation of the risk of prenatal anomalies.
Device Classification:
Annex II List B
Device Descriptions:
Benetech PRA Software for estimating the risk of having a fetus with a range of congenital abnormalities including Trisomy 21
Model:
2.4.x.x
“We are very excited to receive this certification for the European market”, said company founder Ken McEvoy, “It’s just another affirmation that Benetech PRA is a top quality product and is suitable for use in the most stringent prenatal screening practices.”
Contact:
Les Hansen
President
Benetech Inc.
www.benetech.com
1 800 253 8611
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About Benetech Inc.
Located in Toronto Canada, Benetech was founded in 1987 and has been privately owned and operated ever since. Benetech PRA is used by some of the leading hospitals and labs in the world and is considered a gold standard for prenatal screening. The quality systems of Benetech Inc. have been registered by UL LLC.® to ISO 13485:2003. More information on Benetech Inc. and its products can be found at www.benetech.com.
About UL
UL LLC.® is a premier global independent safety science company with more than 118 years of history. Employing more than 10,000 professionals in over 100 countries, UL has five distinct business units – Product Safety, Environment, Life & Health, Knowledge Services, and Verification Services – to meet the expanding needs of our customers and to deliver on our public safety mission. Additional information about UL may be found at UL.com.