<?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>e0b4154a-2543-4b38-afae-e975e51583e5</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2025-02-17</publicVersionDate><devicePublishDate>2017-07-04</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>08718375863589</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>Technomed Europe</brandName><versionModelNumber>TE/S49-638</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>418415568</dunsNumber><companyName>Technomed Engineering B.V.</companyName><deviceCount>1</deviceCount><deviceDescription>Disposable Subdermal Needle Electrode; 1.5m wire
</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+31434086868</phone><phoneExtension xsi:nil="true"/><email>info@technomed.nl</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>47714</gmdnCode><gmdnPTName>Subdermal needle electrode</gmdnPTName><gmdnPTDefinition>A sterile, multi-purpose electrical conductor inserted beneath the dermal layer of a patient&apos;s skin to record/monitor electrical activity (biopotentials) for physiological measurements [typically electroencephalography (EEG), electromyography (EMG), and evoked-potential) and often to provide electrical stimulation. It typically consists of thin shaft of stainless steel connected to a lead wire that terminates with a safety connector for attachment to recording/monitoring and stimulation systems. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>GXZ</productCode><productCodeName>Electrode, Needle</productCodeName></fdaProductCode><fdaProductCode><productCode>IKT</productCode><productCodeName>Electrode, Needle, Diagnostic Electromyograph</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Length</sizeType><size unit="Millimeter" value="19"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Outer Diameter</sizeType><size unit="Millimeter" value="0.45"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Needle Gauge</sizeType><size unit="Gauge" value="26"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>