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<eudamedExport entity="devices">
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    <basicUdiDi>B-07613427002040</basicUdiDi>
    <tradeName>OneTouch Verio Control Solution</tradeName>
    <deviceName>OneTouch Verio Control Solution</deviceName>
    <manufacturerName>LifeScan Europe GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000014224</manufacturerSrn>
    <authorisedRepresentativeName>LifeScan Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005105</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>022222</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:50:32.758Z</lastUpdated>
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  <row>
    <udiDi>07613427001487</udiDi>
    <basicUdiDi>B-07613427001487</basicUdiDi>
    <tradeName>OneTouch Select Plus Control Solution</tradeName>
    <deviceName>OneTouch Select Plus Control Solution</deviceName>
    <manufacturerName>LifeScan Europe GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000014224</manufacturerSrn>
    <authorisedRepresentativeName>LifeScan Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005105</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>023284</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:50:25.548Z</lastUpdated>
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    <udiDi>07613427000503</udiDi>
    <basicUdiDi>B-07613427000503</basicUdiDi>
    <tradeName>OneTouch Verio Control Solution</tradeName>
    <deviceName>OneTouch Verio Control Solution</deviceName>
    <manufacturerName>LifeScan Europe GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000014224</manufacturerSrn>
    <authorisedRepresentativeName>LifeScan Deutschland GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005105</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>022227</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:50:19.141Z</lastUpdated>
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    <udiDi>06978139071267</udiDi>
    <basicUdiDi>B-06978139071267</basicUdiDi>
    <tradeName>HbA1c Control</tradeName>
    <deviceName>HbA1c Control</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320301151</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:38:54.602Z</lastUpdated>
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    <udiDi>06976374752361</udiDi>
    <basicUdiDi>B-06976374752361</basicUdiDi>
    <tradeName>Quanlity Control For Urine Analyzer</tradeName>
    <deviceName>Quanlity Control For Urine Analyzer</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050207</emdnCode>
    <emdnDescription>URINE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BQ-B  U1: 1 × 8 mL; U2: 1 × 8 mL; U3: 1 × 8 mL（DR089）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:44:05.698Z</lastUpdated>
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    <udiDi>06976374752354</udiDi>
    <basicUdiDi>B-06976374752354</basicUdiDi>
    <tradeName>Quanlity Control For Urine Analyzer</tradeName>
    <deviceName>Urine Analysis Test Strips (Dry Chemistry Method)</deviceName>
    <manufacturerName>BIOBASE POCT CO.,LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045945</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050207</emdnCode>
    <emdnDescription>URINE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BQ-A  U1: 1 × 8 mL; U2: 1 × 8 mL; U3: 1 × 8 mL（DR088）</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:44:04.015Z</lastUpdated>
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    <udiDi>06975519631448</udiDi>
    <basicUdiDi>B-06975519631448</basicUdiDi>
    <tradeName>Vivadiag</tradeName>
    <deviceName>Lipid Testing System Control Solution</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050202</emdnCode>
    <emdnDescription>LIPID CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LA-137-2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:33:16.316Z</lastUpdated>
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    <udiDi>06975519631431</udiDi>
    <basicUdiDi>B-06975519631431</basicUdiDi>
    <tradeName>Vivadiag</tradeName>
    <deviceName></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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050202</emdnCode>
    <emdnDescription>LIPID CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LA-137-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:33:15.522Z</lastUpdated>
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    <udiDi>06975519630656</udiDi>
    <basicUdiDi>B-06975519630656</basicUdiDi>
    <tradeName>Vivadiag</tradeName>
    <deviceName>Lipid Testing System Control Solution</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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050202</emdnCode>
    <emdnDescription>LIPID CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LA-133-1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:33:03.505Z</lastUpdated>
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  <row>
    <udiDi>06975200381157</udiDi>
    <basicUdiDi>B-06975200381157</basicUdiDi>
    <tradeName>06975200381157</tradeName>
    <deviceName>Electrolyte Multiple Quality Control</deviceName>
    <manufacturerName>Shenzhen Xilaiheng Medical Electronics Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000047090</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q301</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:07:57.192Z</lastUpdated>
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    <udiDi>06974735362358</udiDi>
    <basicUdiDi>B-06974735362358</basicUdiDi>
    <tradeName>KEYU Urine Analyzer Quality Control Set</tradeName>
    <deviceName>Urine Analyzer Quality Control Set</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050207</emdnCode>
    <emdnDescription>URINE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UP-QC-Ⅳ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:37:01.509Z</lastUpdated>
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  <row>
    <udiDi>06974735362341</udiDi>
    <basicUdiDi>B-06974735362341</basicUdiDi>
    <tradeName>KEYU Urine Analyzer Quality Control Set</tradeName>
    <deviceName>Urine Analyzer Quality Control Set</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050207</emdnCode>
    <emdnDescription>URINE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UP-QC-Ⅲ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:37:00.686Z</lastUpdated>
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  <row>
    <udiDi>06974735362334</udiDi>
    <basicUdiDi>B-06974735362334</basicUdiDi>
    <tradeName>KEYU Urine Analyzer Quality Control Set</tradeName>
    <deviceName>Urine Analyzer Quality Control Set</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050207</emdnCode>
    <emdnDescription>URINE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UP-QC-Ⅱ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:36:59.889Z</lastUpdated>
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    <udiDi>06974735362327</udiDi>
    <basicUdiDi>B-06974735362327</basicUdiDi>
    <tradeName>KEYU Urine Analyzer Quality Control Set</tradeName>
    <deviceName>Urine Analyzer Quality Control Set</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050207</emdnCode>
    <emdnDescription>URINE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>UP-QC-Ⅰ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:36:59.092Z</lastUpdated>
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    <udiDi>06974735361535</udiDi>
    <basicUdiDi>B-06974735361535</basicUdiDi>
    <tradeName>KEYU Urine Analysis Specific Gravity Quality Control</tradeName>
    <deviceName>Urine Analysis Specific Gravity Quality Control</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050207</emdnCode>
    <emdnDescription>URINE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SG-QC-Ⅰ</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:36:11.065Z</lastUpdated>
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    <udiDi>06972337850150</udiDi>
    <basicUdiDi>B-06972337850150</basicUdiDi>
    <tradeName>06972337850150</tradeName>
    <deviceName>Electrolyte Control</deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050204</emdnCode>
    <emdnDescription>ELECTROLYTE CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QC-5  low：2.0mL×5、normal：2.0mL×5、high：2.0mL×5</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:49:02.064Z</lastUpdated>
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    <udiDi>06972235844947</udiDi>
    <basicUdiDi>B-06972235844947</basicUdiDi>
    <tradeName>Vaginitis Diagnosis Quality Control Kit</tradeName>
    <deviceName>Vaginitis Diagnosis Quality Control Kit</deviceName>
    <manufacturerName>Zhuhai Lituo Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000026852</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050299</emdnCode>
    <emdnDescription>SPECIFIC CONTROLS (CC) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LTA120101</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:47:51.601Z</lastUpdated>
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    <udiDi>06971969566125</udiDi>
    <basicUdiDi>B-06971969566125</basicUdiDi>
    <tradeName>Blood Glucose Control Solutions</tradeName>
    <deviceName>Blood Glucose Control Solutions</deviceName>
    <manufacturerName>YASEE BioMedical Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000037011</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCS-L2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:26:38.937Z</lastUpdated>
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    <udiDi>06971969566118</udiDi>
    <basicUdiDi>B-06971969566118</basicUdiDi>
    <tradeName>Blood Glucose Control Solutions</tradeName>
    <deviceName>Blood Glucose Control Solutions</deviceName>
    <manufacturerName>YASEE BioMedical Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000037011</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GCS-L1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T11:26:38.137Z</lastUpdated>
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    <udiDi>06971225937966</udiDi>
    <basicUdiDi>B-06971225937966</basicUdiDi>
    <tradeName>A1c Go HbA1c Control</tradeName>
    <deviceName>A1c Go HbA1c Control</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050205</emdnCode>
    <emdnDescription>DIABETES CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBDMAC2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:29:46.022Z</lastUpdated>
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