<?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>23205201-d3ef-4729-95bd-c6d808251bb4</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2026-05-18</publicVersionDate><devicePublishDate>2023-03-15</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>08720256698050</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>Onera STS</brandName><versionModelNumber>01.00</versionModelNumber><catalogNumber>ONERA STS1 FLOW</catalogNumber><dunsNumber>492293557</dunsNumber><companyName>Onera B.V.</companyName><deviceCount>1</deviceCount><deviceDescription xsi:nil="true"/><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>+31403082177</phone><phoneExtension xsi:nil="true"/><email>info@onerahealth.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>47567</gmdnCode><gmdnPTName>Polysomnography analyser</gmdnPTName><gmdnPTDefinition>A mains electricity (AC-powered) device designed to record and interpret a variety of physiologic functions during sleep to evaluate sleep/sleep-related disorders (e.g., insomnia, hypersomnia, apnoea). It typically performs electroencephalography, electrocardiography, electro-oculography, electromyography, and respiration, temperature, and pulse oximetry readings. It may also provide audiovisual information about the sleeping patient for behavioral analysis and other measurements (e.g., gastric reflux, bedwetting). The device includes electrodes, measuring instruments, samplers, filters, amplifiers, and appropriate software for processing data and providing patient diagnoses.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>MNR</productCode><productCodeName>Ventilatory Effort Recorder</productCodeName></fdaProductCode><fdaProductCode><productCode>OLV</productCode><productCodeName>Standard Polysomnograph With Electroencephalograph</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Weight</sizeType><size unit="Gram" value="54"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Height</sizeType><size unit="Millimeter" value="21"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Length</sizeType><size unit="Millimeter" value="82"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Width</sizeType><size unit="Millimeter" value="63.5"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions><storageHandling><storageHandlingType>Storage Environment Humidity</storageHandlingType><storageHandlingHigh unit="Percent (%) Relative Humidity" value="90"/><storageHandlingLow unit="Percent (%) Relative Humidity" value="10"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="40"/><storageHandlingLow unit="Degrees Celsius" value="10"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>