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    <tradeName>06975146600008</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1 test/package</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:38:34.446Z</lastUpdated>
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    <udiDi>06975146600015</udiDi>
    <basicUdiDi>B-06975146600015</basicUdiDi>
    <tradeName>06975146600015</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:38:34.426Z</lastUpdated>
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    <udiDi>06975146600022</udiDi>
    <basicUdiDi>B-06975146600022</basicUdiDi>
    <tradeName>06975146600022</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:38:34.410Z</lastUpdated>
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    <udiDi>06975146600039</udiDi>
    <basicUdiDi>B-06975146600039</basicUdiDi>
    <tradeName>06975146600039</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:38:34.401Z</lastUpdated>
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    <udiDi>06975146600138</udiDi>
    <basicUdiDi>B-06975146600138</basicUdiDi>
    <tradeName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPX00101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:38:34.384Z</lastUpdated>
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    <udiDi>06975146600145</udiDi>
    <basicUdiDi>B-06975146600145</basicUdiDi>
    <tradeName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPX00101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:38:34.370Z</lastUpdated>
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    <udiDi>06975146600152</udiDi>
    <basicUdiDi>B-06975146600152</basicUdiDi>
    <tradeName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPX00120</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:38:34.350Z</lastUpdated>
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    <udiDi>06975146600169</udiDi>
    <basicUdiDi>B-06975146600169</basicUdiDi>
    <tradeName>06975146600169</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPX00101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:38:34.336Z</lastUpdated>
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    <udiDi>06975146600176</udiDi>
    <basicUdiDi>B-06975146600176</basicUdiDi>
    <tradeName>06975146600176</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPX00205</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:38:34.320Z</lastUpdated>
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    <udiDi>06975146600183</udiDi>
    <basicUdiDi>B-06975146600183</basicUdiDi>
    <tradeName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPX00205</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:38:34.293Z</lastUpdated>
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    <udiDi>06975146600190</udiDi>
    <basicUdiDi>B-06975146600190</basicUdiDi>
    <tradeName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPX00205</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:38:34.284Z</lastUpdated>
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    <udiDi>06975146600206</udiDi>
    <basicUdiDi>B-06975146600206</basicUdiDi>
    <tradeName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPX00305</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:38:34.260Z</lastUpdated>
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    <udiDi>06975146600213</udiDi>
    <basicUdiDi>B-06975146600213</basicUdiDi>
    <tradeName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPX00320</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:38:34.237Z</lastUpdated>
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  <row>
    <udiDi>06975146600220</udiDi>
    <basicUdiDi>B-06975146600220</basicUdiDi>
    <tradeName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPX00401</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:38:34.215Z</lastUpdated>
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    <udiDi>06975146600237</udiDi>
    <basicUdiDi>B-06975146600237</basicUdiDi>
    <tradeName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPX00405</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:38:34.194Z</lastUpdated>
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    <udiDi>06975146600244</udiDi>
    <basicUdiDi>B-06975146600244</basicUdiDi>
    <tradeName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPX00420</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:38:34.173Z</lastUpdated>
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    <udiDi>06975146600251</udiDi>
    <basicUdiDi>B-06975146600251</basicUdiDi>
    <tradeName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPX00501</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:38:34.160Z</lastUpdated>
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    <udiDi>06975146600268</udiDi>
    <basicUdiDi>B-06975146600268</basicUdiDi>
    <tradeName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPX00505</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:38:34.134Z</lastUpdated>
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    <udiDi>06975146600275</udiDi>
    <basicUdiDi>B-06975146600275</basicUdiDi>
    <tradeName>Rapid Monkeypox Virus Antigen Test Cassette (Colloidal gold)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MPX00520</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:38:34.112Z</lastUpdated>
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    <udiDi>06975146603665</udiDi>
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    <tradeName>06975146603665</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BioDetect（Xiamen）Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000001098</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100 tests/kit</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:38:34.090Z</lastUpdated>
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