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bobby1151

05/22/26 12:20 PM

#353606 RE: Bielleaver #353605

CE Mark is only required for product's sold in the European Economic Area (EEA) & for Medical Devices - I THINK??
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The_Pro

05/22/26 1:57 PM

#353613 RE: Bielleaver #353605

NOT CURRENT

the Company also held CE Mark certification for both ActiPatch® and RecoveryRx® devices for sale in European markets. The Company elected not to renew the CE Mark certification due to limited commercial revenue in those markets relative to the ongoing regulatory costs associated with maintaining certification under the European Union Medical Device Regulation (“EU MDR”).