FUJIFILM Irvine Scientific, Inc., a world leader in the innovation, development and manufacture of cell culture media and Assisted Reproductive Technologies (ART), today announced the receipt of CE Mark approval for key ART products. CE Marking is a distinction that the products conform to standards set by the European Union health and safety legislation.
The products that received CE Marking include:
- Continuous Single Culture-NX (CSCM-NX) and Continuous Single Culture-NX Complete (CSCM-NXC). A clinically-proven, low lactate single-step medium that helps improve blastocyst development. Available with and without human serum albumin (HSA) protein supplement.
- Arctic Sperm Cryopreservation Medium. A TEST-yolk buffer-free, dual-buffered medium designed for modern sperm processing.
- Multipurpose Handling Medium (MHM) in a 12X12 configuration. A dual-buffer handling medium that maintains a stable environment for all manipulations performed outside of the incubator, such as oocyte retrieval and rinsing, sperm processing and intracytoplasmic sperm injection, (ICSI), and embryo transfer.
FUJIFILM Irvine Scientific is devoted to meeting or exceeding regulatory standards worldwide and was one of the first ART manufacturing companies in the United States to receive ISO 13485 Quality System certification, the rigorous international quality assurance standard designed specifically for medical devices. Each product is manufactured in accordance with the Guidelines for Manufacture of Medical Device and In Vitro Diagnostic Products and the Good Manufacturing Practices (GMPs) for Medical Devices.
FUJIFILM Irvine Scientific leads the way in production of high-quality ART solutions that consistently meet worldwide regulatory requirements. We are pleased to now offer these innovative solutions to all of our European customers.”
Marc Brignola, Senior Director Sales and Marketing, Assisted Reproductive Technologies