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    <tradeName>KEYU Fecal Occult Blood Rapid Test (Colloidal Gold)</tradeName>
    <deviceName>Fecal Occult Blood Rapid Test (Colloidal Gold)</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>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FOB-R-F</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:33:42.469Z</lastUpdated>
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    <udiDi>06974735360859</udiDi>
    <basicUdiDi>B-06974735360859</basicUdiDi>
    <tradeName>KEYU Fecal Occult Blood Rapid Test (Colloidal Gold)</tradeName>
    <deviceName>Fecal Occult Blood Rapid Test (Colloidal Gold)</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>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FOB-R-G</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:33:41.673Z</lastUpdated>
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    <udiDi>06974735360798</udiDi>
    <basicUdiDi>B-06974735360798</basicUdiDi>
    <tradeName>KEYU Fecal Occult Blood Diagnostic Kit (colloidal gold method)</tradeName>
    <deviceName>Fecal Occult Blood Diagnostic Kit (colloidal gold method)</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FOB-A</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:33:36.060Z</lastUpdated>
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    <udiDi>06974735360651</udiDi>
    <basicUdiDi>B-06974735360651</basicUdiDi>
    <tradeName>KEYU Fecal Occult Blood Diagnostic Kit (colloidal gold method)</tradeName>
    <deviceName>Fecal Occult Blood Diagnostic Kit (colloidal gold method)</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FOB-C</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:33:24.052Z</lastUpdated>
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    <udiDi>06974735360378</udiDi>
    <basicUdiDi>B-06974735360378</basicUdiDi>
    <tradeName>KEYU Fecal Occult Blood Diagnostic Kit (colloidal gold method)</tradeName>
    <deviceName>Fecal Occult Blood Diagnostic Kit (colloidal gold method)</deviceName>
    <manufacturerName>Zhuhai Keyu Biological Engineering Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000023195</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FOB-B</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:32:39.163Z</lastUpdated>
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    <udiDi>06971124113003</udiDi>
    <basicUdiDi>697112411AHPA015E</basicUdiDi>
    <tradeName>Automatic Homogenization Processor</tradeName>
    <deviceName>Automatic Homogenization Processor</deviceName>
    <manufacturerName>Xiamen Sciendox Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029485</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6000A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:37:56.907Z</lastUpdated>
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    <udiDi>06971124110200</udiDi>
    <basicUdiDi>697112411SLPA01E4</basicUdiDi>
    <tradeName>Sample liquefaction processor</tradeName>
    <deviceName>Sample liquefaction processor</deviceName>
    <manufacturerName>Xiamen Sciendox Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029485</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:37:35.251Z</lastUpdated>
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    <udiDi>06971124110002</udiDi>
    <basicUdiDi>697112411FAS00137</basicUdiDi>
    <tradeName>06971124110002</tradeName>
    <deviceName>Feces Analysis System</deviceName>
    <manufacturerName>Xiamen Sciendox Biological Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029485</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2000R</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:37:34.441Z</lastUpdated>
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    <udiDi>06970581430647</udiDi>
    <basicUdiDi>B-06970581430647</basicUdiDi>
    <tradeName>Accu-Tell® FOB Strip (Feces)</tradeName>
    <deviceName>Accu-Tell® FOB Strip</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-FOB-A22</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:42:50.872Z</lastUpdated>
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    <udiDi>06970581430432</udiDi>
    <basicUdiDi>B-06970581430432</basicUdiDi>
    <tradeName>Accu-Tell® FOB Cassette (Feces)</tradeName>
    <deviceName>Accu-Tell® Rapid FOB Test</deviceName>
    <manufacturerName>AccuBioTech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025172</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABT-FOB-B22</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T02:42:19.659Z</lastUpdated>
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    <udiDi>06970522647561</udiDi>
    <basicUdiDi>697052264SJPOZ0006VK</basicUdiDi>
    <tradeName>Hemoglobin &amp; Transferrin (FOB&amp;TF) non-quantitative  quality control</tradeName>
    <deviceName>Hemoglobin &amp; Transferrin (FOB&amp;TF) non-quantitative  quality control</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB0333C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:47:00.084Z</lastUpdated>
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    <udiDi>06970522646458</udiDi>
    <basicUdiDi>B-06970522646458</basicUdiDi>
    <tradeName>Group A Rotavirus &amp; Adenovirus Antigen Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Group A Rotavirus &amp; Adenovirus Antigen Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB1202</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:46:56.485Z</lastUpdated>
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    <udiDi>06970522646151</udiDi>
    <basicUdiDi>B-06970522646151</basicUdiDi>
    <tradeName>Helicobacter Pylori Antigen (HP) Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Helicobacter Pylori Antigen (HP) Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB1003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:46:46.877Z</lastUpdated>
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    <udiDi>06970522645444</udiDi>
    <basicUdiDi>B-06970522645444</basicUdiDi>
    <tradeName>Helicobacter Pylori Antigen (HP) Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Helicobacter Pylori Antigen (HP) Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB1002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:46:37.274Z</lastUpdated>
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    <udiDi>06970522640562</udiDi>
    <basicUdiDi>B-06970522640562</basicUdiDi>
    <tradeName>Lactoferrin (LF) Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Lactoferrin (LF) Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB0602</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:26.414Z</lastUpdated>
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    <udiDi>06970522640531</udiDi>
    <basicUdiDi>B-06970522640531</basicUdiDi>
    <tradeName>Calprotectin (Cal) Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Calprotectin   (Cal) Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB0502</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:24.013Z</lastUpdated>
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    <udiDi>06970522640432</udiDi>
    <basicUdiDi>B-06970522640432</basicUdiDi>
    <tradeName>Fecal Occult Blood &amp; Transferrin(FOB&amp;TF) Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Fecal Occult Blood &amp; Transferrin(FOB&amp;TF) Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB0303</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:22.804Z</lastUpdated>
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    <udiDi>06970522640425</udiDi>
    <basicUdiDi>B-06970522640425</basicUdiDi>
    <tradeName>Fecal Occult Blood &amp; Transferrin(FOB&amp;TF) Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Fecal Occult Blood &amp; Transferrin(FOB&amp;TF) Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB0302</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:20.402Z</lastUpdated>
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    <udiDi>06970522640388</udiDi>
    <basicUdiDi>B-06970522640388</basicUdiDi>
    <tradeName>Norovirus Antigen Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Norovirus Antigen Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Share info GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005132</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB1301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:14.402Z</lastUpdated>
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    <udiDi>06970522640326</udiDi>
    <basicUdiDi>B-06970522640326</basicUdiDi>
    <tradeName>Transferrin (TF) Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Transferrin (TF) Test Kit (Colloidal Gold)</deviceName>
    <manufacturerName>Sichuan Orienter Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000003026</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BB0203</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-30T01:45:13.197Z</lastUpdated>
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