CE Марка Irvine Scientific

Irvine Scientific, a leader in Assisted Reproductive Technologies (ART) announced today that it has received CE mark for a full range of its media designed for ART: Complete P-1® Medium with DSS™, Blastocyst Freeze Media, Blastocyst Thaw Media, Embryo Freeze Media, Embryo Thaw Media, Complete Early Cleavage Medium® (ECM®) with DSS™ and Complete MultiBlast Medium® with DSS™, Sperm Washing Medium, Sperm Maintenance Medium w/ HSA, 7% PVP w/ HSA, 10% PVP w/ HSA.

CE mark on ART products demonstrates that the manufacturer’s products comply with the relevant European health and safety legislation. CE Marking is widely recognized by regulatory authorities around the world. Irvine Scientific’s commitment to quality begins with strict adherence to regulatory guidelines. Irvine Scientific seeks to have regulatory approval for all its products worldwide and the European CE Mark is another step in this direction.

“We at Irvine Scientific are pleased to share this achievement especially with our European customers and network of distributors. We are also proud to be the only US based manufacturer of ART media to have received CE mark on a complete range of our culture media after having undergone extensive review from European Regulatory bodies.” said Tim Mullane, Chief Operating Officer, Irvine Scientific.

Irvine Scientific, a subsidiary of Japan Energy Corporation, is a leading manufacturer and supplier of ART products, medical devices, cytogenetics, and a wide range of cell culture media.

Date:    March 30th, 2010

Irvine Scientific, a leader in Assisted Reproductive Technology (ART), announced today it received CE mark approval for its Vit Kit®-Freeze, Vit Kit®-Thaw and Oil for Embryo Culture.
This news accompanies the recent announcement of CE mark approval for a number of other media for ART from Irvine Scientific.

CE is a mandatory conformity mark in European Economic Area for certain product groups to in dicate compliance with the essential consumer safety, health and environmental requirements as
set out in European Directives and is widely recognized by regulatory authorities around the world.
“Irvine Scientific’s commitment to deliver outstanding products includes strict adherence to regulatory guidelines. Our ART customers expect the highest quality products and service from their culture media suppliers and recognize CE mark as an indicator of high product quality control and good manufacturing management.
The addition of CE mark on our vitrification and oil products
will drive us forward into the European market," said Makoto Shintani, President and CEO, Irvine
Scientific.