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    <tradeName>Sinocare iCan</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1204011502</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N/A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:47:59.679Z</lastUpdated>
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    <udiDi>06934175033928</udiDi>
    <basicUdiDi>6934175005A0003PR</basicUdiDi>
    <tradeName>Sinocare iCan® view Glucose Data Reader</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1204011502</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MDA 0204</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:47:59.519Z</lastUpdated>
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    <udiDi>06934175033966</udiDi>
    <basicUdiDi>6934175005A0001PM</basicUdiDi>
    <tradeName>GlucoMen® iCan</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z1204011502</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>59061</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:47:59.494Z</lastUpdated>
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    <udiDi>04015630888139</udiDi>
    <basicUdiDi>B-04015630888139</basicUdiDi>
    <tradeName>Accu-Chek Insight</tradeName>
    <deviceName>Accu-Chek Insight Meter mmol/L Replacement Kit</deviceName>
    <manufacturerName>Roche Diabetes Care GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006276</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>Z1204011502</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07249241001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:42:27.172Z</lastUpdated>
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    <udiDi>04015630083435</udiDi>
    <basicUdiDi>B-04015630083435</basicUdiDi>
    <tradeName>Accu-Chek Instant</tradeName>
    <deviceName>ACCU-CHEK INSTANT MMOL/L SC SET</deviceName>
    <manufacturerName>Roche Diabetes Care GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006276</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>Z1204011502</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09221808054</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:42:24.771Z</lastUpdated>
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    <udiDi>04015630083428</udiDi>
    <basicUdiDi>B-04015630083428</basicUdiDi>
    <tradeName>Accu-Chek Instant</tradeName>
    <deviceName>ACCU-CHEK INSTANT MMOL/L KIT</deviceName>
    <manufacturerName>Roche Diabetes Care GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006276</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>Z1204011502</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09221786041</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:42:22.352Z</lastUpdated>
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  <row>
    <udiDi>04015630070732</udiDi>
    <basicUdiDi>B-04015630070732</basicUdiDi>
    <tradeName>Accu-Chek</tradeName>
    <deviceName>Accu-Chek Guide Kit mmol/L FC</deviceName>
    <manufacturerName>Roche Diabetes Care GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006276</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>Z1204011502</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07400918057</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:42:19.956Z</lastUpdated>
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    <udiDi>04015630066445</udiDi>
    <basicUdiDi>B-04015630066445</basicUdiDi>
    <tradeName>Accu-Chek Mobile</tradeName>
    <deviceName>ACCU-CHEK Mobile Kit HCP mmol/l</deviceName>
    <manufacturerName>Roche Diabetes Care GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006276</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>Z1204011502</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06383602028</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:42:18.350Z</lastUpdated>
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    <udiDi>04015630063505</udiDi>
    <basicUdiDi>B-04015630063505</basicUdiDi>
    <tradeName>Accu-Chek Aviva</tradeName>
    <deviceName>Accu-Chek Aviva [Model NC] mmol/L Kit</deviceName>
    <manufacturerName>Roche Diabetes Care GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006276</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>Z1204011502</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06988709170</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:42:15.968Z</lastUpdated>
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  <row>
    <udiDi>04015630063161</udiDi>
    <basicUdiDi>B-04015630063161</basicUdiDi>
    <tradeName>Accu-Chek Mobile</tradeName>
    <deviceName>Accu-Chek Mobile LCM mmol/l HCP</deviceName>
    <manufacturerName>Roche Diabetes Care GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006276</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>Z1204011502</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>06383602057</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:42:14.357Z</lastUpdated>
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  <row>
    <udiDi>00386270002792</udiDi>
    <basicUdiDi>B-00386270002792</basicUdiDi>
    <tradeName>Dexcom ONE Continuous Glucose Monitoring System</tradeName>
    <deviceName>Dexcom ONE Continuous Glucose Monitoring System</deviceName>
    <manufacturerName>Dexcom</manufacturerName>
    <manufacturerSrn>US-MF-000010694</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STK-DO-109</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:50:57.234Z</lastUpdated>
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    <udiDi>00386270002785</udiDi>
    <basicUdiDi>B-00386270002785</basicUdiDi>
    <tradeName>Dexcom ONE Continuous Glucose Monitoring System</tradeName>
    <deviceName>Dexcom ONE Continuous Glucose Monitoring System</deviceName>
    <manufacturerName>Dexcom</manufacturerName>
    <manufacturerSrn>US-MF-000010694</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STT-DO-001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:50:54.821Z</lastUpdated>
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    <udiDi>00386270002778</udiDi>
    <basicUdiDi>B-00386270002778</basicUdiDi>
    <tradeName>Dexcom ONE Continuous Glucose Monitoring System</tradeName>
    <deviceName>Dexcom ONE Continuous Glucose Monitoring System</deviceName>
    <manufacturerName>Dexcom</manufacturerName>
    <manufacturerSrn>US-MF-000010694</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STP-DO-002</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:50:53.223Z</lastUpdated>
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    <udiDi>00386270002761</udiDi>
    <basicUdiDi>B-00386270002761</basicUdiDi>
    <tradeName>Dexcom ONE Continuous Glucose Monitoring System</tradeName>
    <deviceName>Dexcom ONE Continuous Glucose Monitoring System</deviceName>
    <manufacturerName>Dexcom</manufacturerName>
    <manufacturerSrn>US-MF-000010694</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STP-DO-109</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:50:52.420Z</lastUpdated>
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    <udiDi>00386270002747</udiDi>
    <basicUdiDi>B-00386270002747</basicUdiDi>
    <tradeName>Dexcom ONE Continuous Glucose Monitoring System</tradeName>
    <deviceName>Dexcom ONE Continuous Glucose Monitoring System</deviceName>
    <manufacturerName>Dexcom</manufacturerName>
    <manufacturerSrn>US-MF-000010694</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STP-DO-101</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:50:50.827Z</lastUpdated>
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    <udiDi>00386270002327</udiDi>
    <basicUdiDi>B-00386270002327</basicUdiDi>
    <tradeName>Dexcom ONE Continuous Glucose Monitoring System</tradeName>
    <deviceName>Dexcom ONE Continuous Glucose Monitoring System</deviceName>
    <manufacturerName>Dexcom</manufacturerName>
    <manufacturerSrn>US-MF-000010694</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STK-DO-013</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:50:48.422Z</lastUpdated>
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    <udiDi>00386270002297</udiDi>
    <basicUdiDi>B-00386270002297</basicUdiDi>
    <tradeName>Dexcom ONE Continuous Glucose Monitoring System</tradeName>
    <deviceName>Dexcom ONE Continuous Glucose Monitoring System</deviceName>
    <manufacturerName>Dexcom</manufacturerName>
    <manufacturerSrn>US-MF-000010694</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STP-DO-005</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:50:46.819Z</lastUpdated>
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    <udiDi>00386270001849</udiDi>
    <basicUdiDi>B-00386270001849</basicUdiDi>
    <tradeName>Dexcom ONE Continuous Glucose Monitoring System</tradeName>
    <deviceName>Dexcom ONE Continuous Glucose Monitoring System</deviceName>
    <manufacturerName>Dexcom</manufacturerName>
    <manufacturerSrn>US-MF-000010694</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STP-DO-102</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:50:46.016Z</lastUpdated>
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    <udiDi>00386270001832</udiDi>
    <basicUdiDi>B-00386270001832</basicUdiDi>
    <tradeName>Dexcom ONE Continuous Glucose Monitoring System</tradeName>
    <deviceName>Dexcom ONE Continuous Glucose Monitoring System</deviceName>
    <manufacturerName>Dexcom</manufacturerName>
    <manufacturerSrn>US-MF-000010694</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STS-DO-003</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:50:44.435Z</lastUpdated>
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    <udiDi>00386270001825</udiDi>
    <basicUdiDi>B-00386270001825</basicUdiDi>
    <tradeName>Dexcom ONE Continuous Glucose Monitoring System</tradeName>
    <deviceName>Dexcom ONE Continuous Glucose Monitoring System</deviceName>
    <manufacturerName>Dexcom</manufacturerName>
    <manufacturerSrn>US-MF-000010694</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1204011585</emdnCode>
    <emdnDescription>INVASIVE BLOOD SUGAR MONITORING SYSTEMS, SINGLE–USE SENSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>STS-DO-001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T13:50:42.049Z</lastUpdated>
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