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    <basicUdiDi>B-06936595752229</basicUdiDi>
    <tradeName>Hemoglobin A1c Dry Chemistry Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZK2204Y2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:31.969Z</lastUpdated>
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    <udiDi>06936595752212</udiDi>
    <basicUdiDi>B-06936595752212</basicUdiDi>
    <tradeName>Hemoglobin A1c Dry Chemistry Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZK2204Y1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:29.579Z</lastUpdated>
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    <udiDi>06936595752205</udiDi>
    <basicUdiDi>B-06936595752205</basicUdiDi>
    <tradeName>Homocysteine Dry Chemistry Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC2202Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:28.388Z</lastUpdated>
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    <udiDi>06936595751925</udiDi>
    <basicUdiDi>B-06936595751925</basicUdiDi>
    <tradeName>hCG Pregnancy Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG2500Y1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:03.139Z</lastUpdated>
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    <udiDi>06936595751918</udiDi>
    <basicUdiDi>B-06936595751918</basicUdiDi>
    <tradeName>Detect 5 Progressive Pregnancy Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060199</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS (CC) - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CG2500Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:58:01.939Z</lastUpdated>
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  <row>
    <udiDi>06936595746129</udiDi>
    <basicUdiDi>B-06936595746129</basicUdiDi>
    <tradeName>Lipid Dry Chemistry Kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>MedicalSystem Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060109</emdnCode>
    <emdnDescription>MULTIPLE PARAMETER BLOOD TEST</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DC2203Y</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T15:52:38.961Z</lastUpdated>
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  <row>
    <udiDi>06936268412900</udiDi>
    <basicUdiDi>B-06936268412900</basicUdiDi>
    <tradeName>06936268412900</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TIANJIN EMPECS MEDICAL DEVICE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000036494</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1066529</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:28:02.225Z</lastUpdated>
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  <row>
    <udiDi>06936268412382</udiDi>
    <basicUdiDi>B-06936268412382</basicUdiDi>
    <tradeName>06936268412382</tradeName>
    <deviceName></deviceName>
    <manufacturerName>TIANJIN EMPECS MEDICAL DEVICE CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000036494</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1062630</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:27:58.591Z</lastUpdated>
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  <row>
    <udiDi>06935784450106</udiDi>
    <basicUdiDi>B-06935784450106</basicUdiDi>
    <tradeName>06935784450106</tradeName>
    <deviceName></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 Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W010106010801</emdnCode>
    <emdnDescription>BLOOD TEST STRIPS CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLU-C12</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:06:43.641Z</lastUpdated>
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  <row>
    <udiDi>06935784450076</udiDi>
    <basicUdiDi>B-06935784450076</basicUdiDi>
    <tradeName>06935784450076</tradeName>
    <deviceName></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 Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLU-S42</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:06:42.432Z</lastUpdated>
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  <row>
    <udiDi>06935784430344</udiDi>
    <basicUdiDi>B-06935784430344</basicUdiDi>
    <tradeName>06935784430344</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP-L224</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:06:35.200Z</lastUpdated>
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  <row>
    <udiDi>06935784430337</udiDi>
    <basicUdiDi>B-06935784430337</basicUdiDi>
    <tradeName>06935784430337</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP-L223</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:06:33.997Z</lastUpdated>
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  <row>
    <udiDi>06935784430320</udiDi>
    <basicUdiDi>B-06935784430320</basicUdiDi>
    <tradeName>06935784430320</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP-L222</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:06:32.799Z</lastUpdated>
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  <row>
    <udiDi>06935784430313</udiDi>
    <basicUdiDi>B-06935784430313</basicUdiDi>
    <tradeName>06935784430313</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP-L221</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:06:31.640Z</lastUpdated>
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  <row>
    <udiDi>06935784430245</udiDi>
    <basicUdiDi>B-06935784430245</basicUdiDi>
    <tradeName>06935784430245</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP-L124</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:06:30.424Z</lastUpdated>
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    <udiDi>06935784430238</udiDi>
    <basicUdiDi>B-06935784430238</basicUdiDi>
    <tradeName>06935784430238</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP-L123</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:06:29.218Z</lastUpdated>
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    <udiDi>06935784430221</udiDi>
    <basicUdiDi>B-06935784430221</basicUdiDi>
    <tradeName>06935784430221</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP-L122</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:06:28.031Z</lastUpdated>
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    <udiDi>06935784430214</udiDi>
    <basicUdiDi>B-06935784430214</basicUdiDi>
    <tradeName>06935784430214</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HP-L121</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:06:26.827Z</lastUpdated>
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    <udiDi>06935784420055</udiDi>
    <basicUdiDi>B-06935784420055</basicUdiDi>
    <tradeName>06935784420055</tradeName>
    <deviceName></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 Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101060101</emdnCode>
    <emdnDescription>GLUCOSE TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GLU-S32</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:06:14.810Z</lastUpdated>
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    <udiDi>06935784411176</udiDi>
    <basicUdiDi>B-06935784411176</basicUdiDi>
    <tradeName>06935784411176</tradeName>
    <deviceName></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>UNKNOWN</legislation>
    <emdnCode>W0101060107</emdnCode>
    <emdnDescription>HBA1C TEST STRIPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A1C-S42</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-24T12:06:13.648Z</lastUpdated>
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