AUSTIN, Texas, March 27, 2019 — Global medical device manufacturer, OriGen Biomedical, Inc. announced today that it has received the CE Mark for OriGen’s CryoPur™ sterile cryopreservation solution and CryoStore™ Accessories Product Lines. The CE Mark approval indicates that the CryoPur™ and CryoStore™ products comply with specific standards and requirements of relevant EU Medical Device Directives, enabling OriGen to market and sell its products in all European Union member countries.
“We are pleased and proud that our CryoPur™ solutions and CryoStore™ accessory components are again available to healthcare providers in Europe,” said Richard Martin, CEO and President of OriGen Biomedical, Inc. “We would like to thank everybody who expressed interest and support of these products for their patience and understanding during the reinstatement of the CE Mark.”
The CE Mark was temporarily suspended due to lack of technical file documentation at the time of audit, as the application involved rigorous review against safety standards. The CE Mark reinstatement is the third major global regulatory milestone for OriGen for the last several months, following the FDA 510 (k) clearance for the CryoStore™ Multi-Chamber Freezing Bag, and the award of ISO 13485:2016 Certification and MDSAP Certification for product manufacturing. Quality is the foundation of OriGen products, and all these regulatory achievements demonstrate OriGen’s commitment to provide high quality medical devices improving patients’ health worldwide.
OriGen Biomedical, Inc
OriGen Biomedical, Inc. is a leading producer of cryopreservation, cell culture, and ECMO respiratory products. OriGen’s focus is to produce a range of products to treat respiratory distress, cancer, genetic conditions, and other life-threatening diseases. Our products are designed with the patient and user in mind and we strive to maintain excellent customer service to ensure that patient care is the priority.
OriGen Biomedical is a growing, privately-held medical device manufacturer founded in 1997 and headquartered in Austin, Texas. Our engineers have many years of experience with dozens of different specialty medical devices. OriGen is certified annually to ISO 13485 standards, and regularly inspected by the FDA, ISO-certification organizations, and our customers.
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