InGeneron, Inc. Announces EU Quality Management System Certificate Under MDR Regulation (EU) 2017/745 for Medical Devices [Yahoo! Finance]
INTERTEK GROUP UNSP/ADR (IKTSY)
NASDAQ:AMEX Investor Relations:
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Source: Yahoo! Finance
announced receipt of a CE Certificate (No. 28620235524 issued January 19, 2026) for the Transpose Ultra ® (Sterile Kit) and the Processing Unit (Centrifuge) in accordance with Regulation (EU) 2017/745 on medical devices (the Medical Device Regulation, MDR). Intertek Medical Notified Body AB (2862) conducted an extensive review of the submitted Technical Documentation and performed Quality Management System audits in accordance with ISO 13485. The Transpose Ultra System was first certified in the European Union on March 25, 2015, as a "Class I Sterile" device under the Medical Device Directive (MDD 93/42/EEC) thereby allowing the CE mark to be affixed to the product and its labeling. Dr. Eckhard Alt, MD, PhD, Executive Chairman of InGeneron, Inc. stated that receipt of MDR certification marks an important milestone in the Company's continued ability to provide cell therapy medical devices in the European Union and for future growth in other markets. This certification by Intertek, an
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