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    <udiDi>D-02B0026YT</udiDi>
    <basicUdiDi>B-02B0026YT</basicUdiDi>
    <tradeName>D-02B0026YT</tradeName>
    <deviceName>Pepsinogen I/Pepsinogen II Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2X001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:29:23.852Z</lastUpdated>
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    <udiDi>D-02B0022YK</udiDi>
    <basicUdiDi>B-02B0022YK</basicUdiDi>
    <tradeName>D-02B0022YK</tradeName>
    <deviceName>Procalcitonin Reagent Kit</deviceName>
    <manufacturerName>Changsha Sinocare Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000012244</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2W001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:29:17.432Z</lastUpdated>
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    <udiDi>D-000012807182061Q5</udiDi>
    <basicUdiDi>B-000012807182061Q5</basicUdiDi>
    <tradeName>G17 Test Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>G17 Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069001</emdnCode>
    <emdnDescription>GASTRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-OT117</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:59:31.659Z</lastUpdated>
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    <udiDi>D-0000128071540B7QX</udiDi>
    <basicUdiDi>B-0000128071540B7QX</basicUdiDi>
    <tradeName>PCT/IL-6 Combined Test Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>PCT/IL-6 Combined Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069099</emdnCode>
    <emdnDescription>INDIVIDUAL AND SPECIFIC HORMONES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-OT122</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:58:34.757Z</lastUpdated>
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    <udiDi>D-0000128071510B2PY</udiDi>
    <basicUdiDi>B-0000128071510B2PY</basicUdiDi>
    <tradeName>PCT Test Kit (Fluorescence Immunoassay)</tradeName>
    <deviceName>PCT Test Kit (Fluorescence Immunoassay)</deviceName>
    <manufacturerName>Jiangsu Macro &amp; Micro-Test Med-Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012807</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWTS-OT098</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T05:58:29.146Z</lastUpdated>
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    <udiDi>06975984062990</udiDi>
    <basicUdiDi>69703416803205093JU</basicUdiDi>
    <tradeName>PCT STAT (eCLIA)</tradeName>
    <deviceName></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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320510402</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T03:32:03.369Z</lastUpdated>
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    <udiDi>06975984063003</udiDi>
    <basicUdiDi>69703416803205093JU</basicUdiDi>
    <tradeName>PCT STAT (eCLIA)</tradeName>
    <deviceName></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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320510403</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T03:32:03.330Z</lastUpdated>
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    <udiDi>06975984063010</udiDi>
    <basicUdiDi>69703416803205093JU</basicUdiDi>
    <tradeName>PCT STAT (eCLIA)</tradeName>
    <deviceName></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 Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320510404</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-04T03:32:03.231Z</lastUpdated>
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    <udiDi>08806133044469</udiDi>
    <basicUdiDi>88061330BD09JB</basicUdiDi>
    <tradeName>ichroma™ PCT</tradeName>
    <deviceName>ichroma™ PCT</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFPC-23-1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:39:16.804Z</lastUpdated>
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  <row>
    <udiDi>08806133044414</udiDi>
    <basicUdiDi>880613300612C8</basicUdiDi>
    <tradeName>AFIAS PCT Plus G</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SMFP-112</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:39:15.998Z</lastUpdated>
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    <udiDi>08806133044377</udiDi>
    <basicUdiDi>880613300128BW</basicUdiDi>
    <tradeName>ichroma™ PCT Plus G</tradeName>
    <deviceName>ichroma™ PCT Plus G</deviceName>
    <manufacturerName>Boditech Med Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000011028</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CFPC-136</reference>
    <placedOnMarketCountry>Lithuania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:39:14.403Z</lastUpdated>
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    <udiDi>08033891322786</udiDi>
    <basicUdiDi>803389132FEL-C007J</basicUdiDi>
    <tradeName>CHORUS FECAL ELASTASE</tradeName>
    <deviceName>CHORUS FECAL ELASTASE</deviceName>
    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000013311</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102069009</emdnCode>
    <emdnDescription>ELASTASE (PANCREATIC POLYPEPTIDE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>86114</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:18:58.863Z</lastUpdated>
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    <udiDi>08033891328474</udiDi>
    <basicUdiDi>803389132CFEL005H</basicUdiDi>
    <tradeName>CHORUS CLIA FECAL ELASTASE</tradeName>
    <deviceName>CHORUS CLIA FECAL ELASTASE</deviceName>
    <manufacturerName>DIESSE Diagnostica Senese S.p.A</manufacturerName>
    <manufacturerSrn>IT-MF-000013311</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102069009</emdnCode>
    <emdnDescription>ELASTASE (PANCREATIC POLYPEPTIDE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>82304</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:15:46.776Z</lastUpdated>
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    <udiDi>08028169208411</udiDi>
    <basicUdiDi>802816920BW01020608053R</basicUdiDi>
    <tradeName>Elafast®</tradeName>
    <deviceName>Elafast®</deviceName>
    <manufacturerName>Eurospital Spa</manufacturerName>
    <manufacturerSrn>IT-MF-000028468</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102069009</emdnCode>
    <emdnDescription>ELASTASE (PANCREATIC POLYPEPTIDE)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9191EP</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:39:39.455Z</lastUpdated>
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    <udiDi>06978465234558</udiDi>
    <basicUdiDi>697846523ProteinB07RL</basicUdiDi>
    <tradeName>Gastrin-17 Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Gastrin-17 Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102069001</emdnCode>
    <emdnDescription>GASTRIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×100 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:34:34.367Z</lastUpdated>
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    <udiDi>06978465234350</udiDi>
    <basicUdiDi>697846523ProteinB06RJ</basicUdiDi>
    <tradeName>Pepsinogen II Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Pepsinogen II Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×100 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:34:31.929Z</lastUpdated>
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    <udiDi>06978465234251</udiDi>
    <basicUdiDi>697846523ProteinB05RG</basicUdiDi>
    <tradeName>Pepsinogen I Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Pepsinogen I Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102069006</emdnCode>
    <emdnDescription>PEPSINOGEN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×100 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:34:30.358Z</lastUpdated>
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    <udiDi>06978465232950</udiDi>
    <basicUdiDi>697846523ProteinB03RC</basicUdiDi>
    <tradeName>Procalcitonin Assay kit(Chemiluminescence Immunoassay Method）</tradeName>
    <deviceName>Procalcitonin Assay kit(Chemiluminescence Immunoassay Method）</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2×100 test</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-02T20:34:25.527Z</lastUpdated>
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    <udiDi>06974472730342</udiDi>
    <basicUdiDi>697447273034MQ</basicUdiDi>
    <tradeName>Procalcitonin (PCT) test kit (fluorescence immunochromatography)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sanqi Biomedical(Shandong)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030641</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4973</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:16:16.496Z</lastUpdated>
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    <udiDi>06974472730335</udiDi>
    <basicUdiDi>697447273033MN</basicUdiDi>
    <tradeName>Procalcitonin (PCT) test kit (fluorescence immunochromatography)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sanqi Biomedical(Shandong)Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030641</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102069013</emdnCode>
    <emdnDescription>PROCALCITONIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4973</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T13:16:15.688Z</lastUpdated>
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