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<eudamedExport entity="devices">
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    <udiDi>06971771202631</udiDi>
    <basicUdiDi>B-06971771202631</basicUdiDi>
    <tradeName>06971771202631</tradeName>
    <deviceName>Blood Ketone Test Strip</deviceName>
    <manufacturerName>Hangzhou Lysun Biotechnology Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000010254</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EKS-101（25PCS）</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-22T20:57:50.505Z</lastUpdated>
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  <row>
    <udiDi>06935784440305</udiDi>
    <basicUdiDi>B-06935784440305</basicUdiDi>
    <tradeName>06935784440305</tradeName>
    <deviceName>Blood Ketone Test Strips</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GUK-S032</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-19T04:57:25.069Z</lastUpdated>
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  <row>
    <udiDi>D-CNMF000014455GUK-S035LL</udiDi>
    <basicUdiDi>B-CNMF000014455GUK-S035LL</basicUdiDi>
    <tradeName>D-CNMF000014455GUK-S035LL</tradeName>
    <deviceName>Blood Ketone Test Strips</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GUK-S035</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:57:04.261Z</lastUpdated>
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  <row>
    <udiDi>D-CNMF000014455GUK-S031LC</udiDi>
    <basicUdiDi>B-CNMF000014455GUK-S031LC</basicUdiDi>
    <tradeName>D-CNMF000014455GUK-S031LC</tradeName>
    <deviceName>Blood Ketone Test Strips</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GUK-S031</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:56:59.127Z</lastUpdated>
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  <row>
    <udiDi>D-CNMF000014455GUK-S034LJ</udiDi>
    <basicUdiDi>B-CNMF000014455GUK-S034LJ</basicUdiDi>
    <tradeName>D-CNMF000014455GUK-S034LJ</tradeName>
    <deviceName>Blood Ketone Test Strips</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GUK-S034</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:56:58.314Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-CNMF000014455GUK-S033LG</udiDi>
    <basicUdiDi>B-CNMF000014455GUK-S033LG</basicUdiDi>
    <tradeName>D-CNMF000014455GUK-S033LG</tradeName>
    <deviceName>Blood Ketone Test Strips</deviceName>
    <manufacturerName>Wuxi Biohermes Bio &amp; Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014455</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GUK-S033</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:56:54.540Z</lastUpdated>
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  <row>
    <udiDi>D-69750225319172CENSXR</udiDi>
    <basicUdiDi>B-69750225319172CENSXR</basicUdiDi>
    <tradeName>D-69750225319172CENSXR</tradeName>
    <deviceName>Blood β-Ketone Test Strips</deviceName>
    <manufacturerName>EAGLENOS SCIENCES, INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000036801</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EN500R1、EN500R2、 EN500R3、 EN500R4</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T01:17:00.730Z</lastUpdated>
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  <row>
    <udiDi>D-KR-MF-000015786BHB9N</udiDi>
    <basicUdiDi>B-KR-MF-000015786BHB9N</basicUdiDi>
    <tradeName>QUCARE® Pro beta-hydroxybutyrate test strip</tradeName>
    <deviceName>QUCARE® Pro</deviceName>
    <manufacturerName>DFI Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000015786</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6022</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T00:44:17.786Z</lastUpdated>
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  <row>
    <udiDi>D-GM771UW</udiDi>
    <basicUdiDi>B-GM771UW</basicUdiDi>
    <tradeName>RIGHTEST Max Dual Blood Glucose and Ketone Monitoring System</tradeName>
    <deviceName>Blood Glucose and Ketone Monitoring System</deviceName>
    <manufacturerName>Bionime Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000008450</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>771K01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T21:42:22.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-BK-SK19S</udiDi>
    <basicUdiDi>B-BK-SK19S</basicUdiDi>
    <tradeName>SANcheck ABEL β-Ketone Test Strip</tradeName>
    <deviceName>β-Ketone Test Strip</deviceName>
    <manufacturerName>General Life Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>TW-MF-000027109</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BK-SK1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:25:41.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8012992BGMSSketEFRL</udiDi>
    <basicUdiDi>B-8012992BGMSSketEFRL</basicUdiDi>
    <tradeName>GlucoMen areo B-Ketone Sensor</tradeName>
    <deviceName>GlucoMen areo B-Ketone Sensor</deviceName>
    <manufacturerName>A. MENARINI Diagnostics S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000023427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48106,48105,49245,48103,48688,48101,47953,47951,47952,48703,48820,48821,48530,48531</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:30:15.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8012992BGMSSketEF2KQ</udiDi>
    <basicUdiDi>B-8012992BGMSSketEF2KQ</basicUdiDi>
    <tradeName>GLUCOFIX TECH  B-Ketone Sensor</tradeName>
    <deviceName>GLUCOFIX TECH  B-Ketone Sensor</deviceName>
    <manufacturerName>A. MENARINI Diagnostics S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000023427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>48726 NL, 49911 FR, 50404 FR-E, 50415 FR, 48583 IT,  57171 UK-IT-FR</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:30:13.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487612AKT27</udiDi>
    <basicUdiDi>B-47136487612AKT27</basicUdiDi>
    <tradeName>MultiSure GK</tradeName>
    <deviceName>MultiSure GK blood ketone test strips</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S5640465, S5640466</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:38.490Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-47136487609BKT3J</udiDi>
    <basicUdiDi>B-47136487609BKT3J</basicUdiDi>
    <tradeName>KETOSURE POC</tradeName>
    <deviceName>KETOSURE POC Blood Ketone Test Strips</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S5640894</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:25.297Z</lastUpdated>
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  <row>
    <udiDi>D-47136487609A06R</udiDi>
    <basicUdiDi>B-47136487609A06R</basicUdiDi>
    <tradeName>KET-1</tradeName>
    <deviceName>KET-1 Blood Ketone Monitoring System</deviceName>
    <manufacturerName>Apex Biotechnology Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000019773</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S11004, S11008, S11009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:56:18.898Z</lastUpdated>
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  <row>
    <udiDi>07640402710324</udiDi>
    <basicUdiDi>B-07640402710324</basicUdiDi>
    <tradeName>FORA 6 𝝱-Ketone Test Strip</tradeName>
    <deviceName>𝝱 Ketone Test Strip</deviceName>
    <manufacturerName>ForaCare Suisse AG</manufacturerName>
    <manufacturerSrn>CH-MF-000019906</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACS053</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-07T04:02:17.375Z</lastUpdated>
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  <row>
    <udiDi>07640143659074</udiDi>
    <basicUdiDi>B-07640143659074</basicUdiDi>
    <tradeName>FORA 6 𝝱-Ketone Test Strip</tradeName>
    <deviceName>β-Ketone test strip</deviceName>
    <manufacturerName>ForaCare Suisse AG</manufacturerName>
    <manufacturerSrn>CH-MF-000019906</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACS053</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:58:03.399Z</lastUpdated>
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  <row>
    <udiDi>07640143658657</udiDi>
    <basicUdiDi>B-07640143658657</basicUdiDi>
    <tradeName>FORA 6 𝝱-Ketone Test Strip</tradeName>
    <deviceName>𝝱 Ketone Test Strip</deviceName>
    <manufacturerName>ForaCare Suisse AG</manufacturerName>
    <manufacturerSrn>CH-MF-000019906</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACS053</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:57:56.192Z</lastUpdated>
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  <row>
    <udiDi>07640143658008</udiDi>
    <basicUdiDi>B-07640143658008</basicUdiDi>
    <tradeName>FORA 6 𝝱-Ketone Test Strip</tradeName>
    <deviceName>𝝱-Ketone Test Strip</deviceName>
    <manufacturerName>ForaCare Suisse AG</manufacturerName>
    <manufacturerSrn>CH-MF-000019906</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACS053</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:57:32.132Z</lastUpdated>
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  <row>
    <udiDi>07640143653737</udiDi>
    <basicUdiDi>B-07640143653737</basicUdiDi>
    <tradeName>FORA 6</tradeName>
    <deviceName>𝝱-Ketone Test Strip</deviceName>
    <manufacturerName>ForaCare Suisse AG</manufacturerName>
    <manufacturerSrn>CH-MF-000019906</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060110</emdnCode>
    <emdnDescription>KETONE TEST STRIPS (Β-HYDROXYBUTYRATE TEST STRIPS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACS053</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:57:06.514Z</lastUpdated>
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</eudamedExport>