<?xml version='1.0' encoding='UTF-8'?><device xmlns='http://www.fda.gov/cdrh/gudid' xmlns:xsi='http://www.w3.org/2001/XMLSchema-instance'><publicDeviceRecordKey>0c0abc6a-cb0d-498b-b432-2489b9ba70f1</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2025-10-07</publicVersionDate><devicePublishDate>2025-09-29</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>B195EE225</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>eego amplifier</brandName><versionModelNumber>EE-225</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>313152485</dunsNumber><companyName>eemagine Medical Imaging Solutions GmbH</companyName><deviceCount>1</deviceCount><deviceDescription>physiological signal amplfier</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>false</lotBatch><serialNumber>true</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>MR Unsafe</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+493029048404</phone><phoneExtension xsi:nil="true"/><email>support@eemagine.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K172312</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>36740</gmdnCode><gmdnPTName>Electroencephalographic signal amplifier</gmdnPTName><gmdnPTDefinition>An electrical device intended to amplify the signal level and to provide impedance matching between two or more medical devices when bioelectrical signals from the brain are transmitted between them.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>GWL</productCode><productCodeName>AMPLIFIER, PHYSIOLOGICAL SIGNAL</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>