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    <tradeName>mylife Aveo Blood Glucose Test Strips</tradeName>
    <deviceName>mylife Aveo Blood Glucose Test Strips</deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>700026226</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:07:38.568Z</lastUpdated>
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    <udiDi>08806712005720</udiDi>
    <basicUdiDi>8806712BGMTS0083M</basicUdiDi>
    <tradeName>mylife Aveo Blood Glucose Test Strips</tradeName>
    <deviceName>mylife Aveo Blood Glucose Test Strips</deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>700026225</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:07:36.057Z</lastUpdated>
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    <udiDi>08806712005713</udiDi>
    <basicUdiDi>8806712BGMTS0083M</basicUdiDi>
    <tradeName>mylife Aveo Blood Glucose Test Strips</tradeName>
    <deviceName>mylife Aveo Blood Glucose Test Strips</deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>700026283</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:07:34.855Z</lastUpdated>
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    <udiDi>08806712005706</udiDi>
    <basicUdiDi>8806712BGMTS0083M</basicUdiDi>
    <tradeName>mylife Aveo Blood Glucose Test Strips</tradeName>
    <deviceName>mylife Aveo Blood Glucose Test Strips</deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>700026282</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:07:33.647Z</lastUpdated>
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    <udiDi>08806712005690</udiDi>
    <basicUdiDi>8806712BGMTS0083M</basicUdiDi>
    <tradeName>mylife Aveo Blood Glucose Test Strips</tradeName>
    <deviceName>mylife Aveo Blood Glucose Test Strips</deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>700026298</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:07:27.655Z</lastUpdated>
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    <udiDi>08806712005683</udiDi>
    <basicUdiDi>8806712BGMTS0083M</basicUdiDi>
    <tradeName>mylife Aveo Blood Glucose Test Strips</tradeName>
    <deviceName>mylife Aveo Blood Glucose Test Strips</deviceName>
    <manufacturerName>i-SENS, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009173</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>700026227</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T03:07:26.469Z</lastUpdated>
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    <udiDi>08800076701328</udiDi>
    <basicUdiDi>88000767BGC0038K</basicUdiDi>
    <tradeName>ConfiGlu G1 Glucose Control solution 3</tradeName>
    <deviceName>ConfiGlu G1 Glucose Control Solution</deviceName>
    <manufacturerName>GenBody Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000043626</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BGC003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T02:32:24.828Z</lastUpdated>
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    <udiDi>08800076701106</udiDi>
    <basicUdiDi>88000767BGC0028H</basicUdiDi>
    <tradeName>ConfiGlu G1 Glucose Control solution 2</tradeName>
    <deviceName>ConfiGlu G1 Glucose Control solution</deviceName>
    <manufacturerName>GenBody Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000043626</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BGC002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T02:32:23.573Z</lastUpdated>
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    <udiDi>08800076700819</udiDi>
    <basicUdiDi>88000767BGSG001FP</basicUdiDi>
    <tradeName>ConfiGlu G1 Blood Glucose Test Strip</tradeName>
    <deviceName>ConfiGlu G1 Blood Glucose Test Strip</deviceName>
    <manufacturerName>GenBody Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000043626</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BGSG001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T02:32:16.451Z</lastUpdated>
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    <udiDi>06970221768697</udiDi>
    <basicUdiDi>B-06970221768697</basicUdiDi>
    <tradeName>Płyn kontrolny do pomiaru stężenia glukozy we krwi VivaChek Fad</tradeName>
    <deviceName>VivaChek Fad Blood Glucose Control Solution</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VGC02-031</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:35:52.011Z</lastUpdated>
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    <udiDi>06970221764132</udiDi>
    <basicUdiDi>B-06970221764132</basicUdiDi>
    <tradeName>VivaChek Fad Blood Glucose Test Strips</tradeName>
    <deviceName>VivaChek Fad Blood Glucose Test Strips</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VGS02-03A</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:35:49.608Z</lastUpdated>
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  <row>
    <udiDi>06970221764125</udiDi>
    <basicUdiDi>B-06970221764125</basicUdiDi>
    <tradeName>VivaChek Fad Blood Glucose Test Strips</tradeName>
    <deviceName>VivaChek Fad Blood Glucose Test Strips</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VGS02-032</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:35:43.598Z</lastUpdated>
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  <row>
    <udiDi>06970221763630</udiDi>
    <basicUdiDi>B-06970221763630</basicUdiDi>
    <tradeName>VivaChek Fad Blood Glucose Test Strips</tradeName>
    <deviceName>VivaChek Fad Blood Glucose Test Strips</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VGS02-038</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:35:41.199Z</lastUpdated>
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    <udiDi>06970221763593</udiDi>
    <basicUdiDi>B-06970221763593</basicUdiDi>
    <tradeName>VivaChek Ino Blood Glucose Test Strips</tradeName>
    <deviceName>VivaChek Ino Blood Glucose Test Strips</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VGS01-019</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:35:39.997Z</lastUpdated>
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    <udiDi>06970221763586</udiDi>
    <basicUdiDi>B-06970221763586</basicUdiDi>
    <tradeName>VivaChek Ino Blood Glucose Test Strips</tradeName>
    <deviceName>VivaChek Ino Blood Glucose Test Strips</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VGS01-014</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:35:33.990Z</lastUpdated>
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    <udiDi>06970221763579</udiDi>
    <basicUdiDi>B-06970221763579</basicUdiDi>
    <tradeName>VivaChek Ino Blood Glucose Test Strips</tradeName>
    <deviceName>VivaChek Ino Blood Glucose Test Strips</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VGS01-013</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:35:32.788Z</lastUpdated>
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    <udiDi>06970221763449</udiDi>
    <basicUdiDi>B-06970221763449</basicUdiDi>
    <tradeName>VivaChek Ino Blood Glucose Test Strips</tradeName>
    <deviceName>VivaChek Ino Blood Glucose Test Strips</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VGS01-017</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:35:31.591Z</lastUpdated>
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    <udiDi>06970221763432</udiDi>
    <basicUdiDi>B-06970221763432</basicUdiDi>
    <tradeName>VivaChek Fad Blood Glucose Test Strips</tradeName>
    <deviceName>VivaChek Fad Blood Glucose Test Strips</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VGS02-035</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:35:30.393Z</lastUpdated>
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    <udiDi>06970221763234</udiDi>
    <basicUdiDi>B-06970221763234</basicUdiDi>
    <tradeName>VivaChek Eco Blood Glucose test strips</tradeName>
    <deviceName>VivaChek Eco Blood Glucose Test Strips</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VGS01-022</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:35:14.793Z</lastUpdated>
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    <udiDi>06970221763142</udiDi>
    <basicUdiDi>B-06970221763142</basicUdiDi>
    <tradeName>VivaChek Ino Blood Glucose Test Strips</tradeName>
    <deviceName>VivaChek Ino Blood Glucose Test Strips</deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VGS01-016</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-06-29T20:35:11.205Z</lastUpdated>
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