Cervos Medical's CERVOS® KeyPRP System Achieves EU MDR Certification Advancing Regenerative Medicine with Quality, Safety, and Exclusive European Distribution through Aspire Medical
AVON, Mass., May 13, 2025 /PRNewswire/ -- Cervos Medical, a wholly owned subsidiary of Ranfac Corp, is proud to announce the CERVOS® KeyPRP System has received official certification under the European Union Medical Device Regulation (MDR) EU 2017/745. This certification affirms the system's compliance with the EU's most stringent standards for medical device safety, performance, and quality.
"Getting CE (MDR) certification for our Platelet Separator isn't just about meeting regulations—it's proof of our commitment to safety, quality, and compliance," said Michaela Gates, Quality Assurance Project Manager at Ranfac. "We are incredibly proud of our team's hard work here at Ranfac. With this certification, we're excited to explore new markets in the EU and see the impact of our CE-marked Platelet Separator growth."
The MDR certification represents a major milestone in Cervos Medical's ongoing mission to support healthcare providers with innovative regenerative solutions. In Europe, the CERVOS® KeyPRP System is available exclusively through Aspire Medical, Cervos's official European sales partner.
"This certification validates our ongoing dedication to product excellence and patient safety," said Eric Kreuz, Vice President of Quality Assurance and Regulatory Affairs at Ranfac. "With the strength and support of our parent company, Ranfac Corp, we are well-positioned to bring innovative regenerative technologies to clinicians and patients across global markets."
Cervos Medical continues to lead in the development of advanced autologous tissue processing systems, supporting clinicians in the areas of platelet-rich plasma (PRP), bone marrow aspiration, and adipose tissue processing.
About Cervos MedicalCervos Medical is a regenerative medicine company focused on developing innovative, minimally invasive technologies for autologous tissue collection and processing. A wholly owned subsidiary of Ranfac Corp, Cervos combines clinical insight with advanced engineering to deliver solutions that meet the highest regulatory and performance standards.
About Ranfac CorporationBased in Avon, Massachusetts, Ranfac Corp has been a trusted name in medical device manufacturing for over 100 years.
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