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<eudamedExport entity="devices">
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    <udiDi>04065803301002</udiDi>
    <basicUdiDi>4065803301GR04ABQL</basicUdiDi>
    <tradeName>Ambistik PFT</tradeName>
    <deviceName>Ambient sensor</deviceName>
    <manufacturerName>Geratherm Respiratory GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159080</emdnCode>
    <emdnDescription>VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>654063</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:47:13.135Z</lastUpdated>
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  <row>
    <udiDi>04065803300005</udiDi>
    <basicUdiDi>4065803300GR04AAPZ</basicUdiDi>
    <tradeName>Ambistik</tradeName>
    <deviceName>Ambient Sensor</deviceName>
    <manufacturerName>Geratherm Respiratory GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159080</emdnCode>
    <emdnDescription>VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>634247</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:47:12.336Z</lastUpdated>
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    <udiDi>04065803203009</udiDi>
    <basicUdiDi>4065803203GR03ADQW</basicUdiDi>
    <tradeName>Diffustik</tradeName>
    <deviceName>Diffustik</deviceName>
    <manufacturerName>Geratherm Respiratory GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159003</emdnCode>
    <emdnDescription>DIFFUSION ANALYSIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>913857</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:47:11.534Z</lastUpdated>
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    <udiDi>04065803202002</udiDi>
    <basicUdiDi>4065803202GR03ACQB</basicUdiDi>
    <tradeName>Add-on CO Diffusion</tradeName>
    <deviceName>Add-on CO Diffusion</deviceName>
    <manufacturerName>Geratherm Respiratory GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159003</emdnCode>
    <emdnDescription>DIFFUSION ANALYSIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>259149</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:47:07.535Z</lastUpdated>
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  <row>
    <udiDi>04065803003005</udiDi>
    <basicUdiDi>4065803003GR01JAPT</basicUdiDi>
    <tradeName>Spiraflow &amp; Softclip Set</tradeName>
    <deviceName>Flow sensor and noseclip</deviceName>
    <manufacturerName>Geratherm Respiratory GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150185</emdnCode>
    <emdnDescription>SPIROMETRY INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>340968</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:47:06.729Z</lastUpdated>
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  <row>
    <udiDi>04065803201012</udiDi>
    <basicUdiDi>4065803201GR03ABPQ</basicUdiDi>
    <tradeName>PFTstik</tradeName>
    <deviceName>Pulmonary Function Testing device</deviceName>
    <manufacturerName>Geratherm Respiratory GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159003</emdnCode>
    <emdnDescription>DIFFUSION ANALYSIS EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>131710</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:47:05.934Z</lastUpdated>
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  <row>
    <udiDi>04065803200008</udiDi>
    <basicUdiDi>4065803200GR03AAP5</basicUdiDi>
    <tradeName>Bodystik</tradeName>
    <deviceName>Bodyplethysmograph</deviceName>
    <manufacturerName>Geratherm Respiratory GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159007</emdnCode>
    <emdnDescription>BODY PLETHYSMOGRAPHS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>785155</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:47:05.132Z</lastUpdated>
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  <row>
    <udiDi>04065803100001</udiDi>
    <basicUdiDi>4065803100GR02AAN9</basicUdiDi>
    <tradeName>Ergostik</tradeName>
    <deviceName>Cardiopulmonary exercise system</deviceName>
    <manufacturerName>Geratherm Respiratory GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159099</emdnCode>
    <emdnDescription>VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>618751</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:47:04.336Z</lastUpdated>
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  <row>
    <udiDi>04065803002008</udiDi>
    <basicUdiDi>4065803002GR01ACNK</basicUdiDi>
    <tradeName>Spirostik Blue</tradeName>
    <deviceName>Wireless Spirometer using Bluetooth 2.0</deviceName>
    <manufacturerName>Geratherm Respiratory GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>356246</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:47:02.735Z</lastUpdated>
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  <row>
    <udiDi>04065803000004</udiDi>
    <basicUdiDi>4065803000GR01AAMD</basicUdiDi>
    <tradeName>Spirostik</tradeName>
    <deviceName>USB 2.0 Spirometer</deviceName>
    <manufacturerName>Geratherm Respiratory GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006818</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>361333</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:47:01.930Z</lastUpdated>
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  <row>
    <udiDi>04057155000658</udiDi>
    <basicUdiDi>4057155Z12159082001KE</basicUdiDi>
    <tradeName>iSpiro</tradeName>
    <deviceName>iSpiro App</deviceName>
    <manufacturerName>eResearchTechnology GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159082</emdnCode>
    <emdnDescription>VAROUS PNEUMOLOGY AND RESPIRATORY PHYSIOPATHOLOGY INSTRUMENTS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1524xx</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:35:25.080Z</lastUpdated>
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  <row>
    <udiDi>04057155000351</udiDi>
    <basicUdiDi>4057155Z12150101003C7</basicUdiDi>
    <tradeName>SpiroSphere</tradeName>
    <deviceName>SpiroSphere</deviceName>
    <manufacturerName>eResearchTechnology GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>707400</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:35:24.268Z</lastUpdated>
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  <row>
    <udiDi>04057155000795</udiDi>
    <basicUdiDi>4057155Z12150101004C9</basicUdiDi>
    <tradeName>iSpiro Ultrasonic Sensor</tradeName>
    <deviceName>iSpiro Ultrasonic Sensor</deviceName>
    <manufacturerName>eResearchTechnology GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>707115</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:35:22.668Z</lastUpdated>
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  <row>
    <udiDi>04057155000191</udiDi>
    <basicUdiDi>4057155Z12150102001CA</basicUdiDi>
    <tradeName>AM3</tradeName>
    <deviceName>Asthma Monitor</deviceName>
    <manufacturerName>eResearchTechnology GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150102</emdnCode>
    <emdnDescription>PEAK FLOW SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1414xx</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:35:20.267Z</lastUpdated>
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  <row>
    <udiDi>04057155000023</udiDi>
    <basicUdiDi>4057155Z12150101001C3</basicUdiDi>
    <tradeName>MasterScope</tradeName>
    <deviceName>MasterScope</deviceName>
    <manufacturerName>eResearchTechnology GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008015</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>171400, 171410</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T17:35:19.465Z</lastUpdated>
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  <row>
    <udiDi>04048551225240</udiDi>
    <basicUdiDi>4048551000132SW</basicUdiDi>
    <tradeName>04048551225240</tradeName>
    <deviceName>Aspirators</deviceName>
    <manufacturerName>KARL STORZ SE &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005723</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159009</emdnCode>
    <emdnDescription>EQUIPMENT FOR REMOVAL OF SECRETIONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10432N</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:27:17.657Z</lastUpdated>
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    <udiDi>04048551048771</udiDi>
    <basicUdiDi>4048551000350TA</basicUdiDi>
    <tradeName>04048551048771</tradeName>
    <deviceName>Atomizes, ear surgery, metal</deviceName>
    <manufacturerName>KARL STORZ SE &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005723</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159002</emdnCode>
    <emdnDescription>AEROSOL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10456C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:23:56.186Z</lastUpdated>
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    <udiDi>04048551048740</udiDi>
    <basicUdiDi>4048551000136T6</basicUdiDi>
    <tradeName>04048551048740</tradeName>
    <deviceName>Atomizers, bronchoscopy</deviceName>
    <manufacturerName>KARL STORZ SE &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005723</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12159002</emdnCode>
    <emdnDescription>AEROSOL EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10454</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T15:23:55.884Z</lastUpdated>
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    <udiDi>03858893574767</udiDi>
    <basicUdiDi>385889357AWOX0016J</basicUdiDi>
    <tradeName>03858893574767</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Awatar Medical Aid d.o.o.</manufacturerName>
    <manufacturerSrn>HR-MF-000025777</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12159004</emdnCode>
    <emdnDescription>OXYGEN CONCENTRATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AW OXC001  10.S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T14:35:07.207Z</lastUpdated>
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    <udiDi>03830059851660</udiDi>
    <basicUdiDi>383005985MTABSYSSPIRORR</basicUdiDi>
    <tradeName>MESI mTABLET SPIRO diagnostic system</tradeName>
    <deviceName>MESI mTABLET SPIRO EN</deviceName>
    <manufacturerName>MESI, razvoj medicinskih naprav, d.o.o.</manufacturerName>
    <manufacturerSrn>SI-MF-000007761</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12150101</emdnCode>
    <emdnDescription>CLINICAL/DIAGNOSTIC SPIROMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301-004300</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-01T13:29:09.321Z</lastUpdated>
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