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    <tradeName>RapidFor™ Rotavirus Rapid Test Kit (FIA)</tradeName>
    <deviceName>Rotavirus Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
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    <reference>VMPO64GD</reference>
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    <lastUpdated>2026-07-09T03:17:28.066Z</lastUpdated>
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    <udiDi>08684595030042</udiDi>
    <basicUdiDi>B-08684595030042</basicUdiDi>
    <tradeName>RapidFor™ Rotavirus Rapid Test Kit (FIA)</tradeName>
    <deviceName>Rotavirus Rapid Test Kit (FIA)</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
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    <udiDi>08683347941308</udiDi>
    <basicUdiDi>B-08683347941308</basicUdiDi>
    <tradeName>RapidFor™ Rotavirus Rapid Test Kit</tradeName>
    <deviceName>Rotavirus Rapid Test Kit</deviceName>
    <manufacturerName>Vitrosens Biotechnology Inc.</manufacturerName>
    <manufacturerSrn>TR-MF-000026452</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <lastUpdated>2026-07-08T21:04:28.002Z</lastUpdated>
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    <udiDi>06977903342114</udiDi>
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    <deviceName>Rotavirus Antigen Rapid Test</deviceName>
    <manufacturerName>GeneSign Biotech (Xiamen)Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000044463</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>GS110504C01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:32:11.117Z</lastUpdated>
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    <udiDi>06976753475720</udiDi>
    <basicUdiDi>B-06976753475720</basicUdiDi>
    <tradeName>Rotavirus Rapid Test Device (feces)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Cybereagen Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000037850</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A440401D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:00:24.319Z</lastUpdated>
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    <udiDi>06974854620575</udiDi>
    <basicUdiDi>B-06974854620575</basicUdiDi>
    <tradeName>JWF</tradeName>
    <deviceName>Rotavirus, Adenovirus Antigen Test Kit</deviceName>
    <manufacturerName>Beijing Jinwofu Bioengineering Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000035739</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2200925</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:52:56.248Z</lastUpdated>
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    <udiDi>06974785750372</udiDi>
    <basicUdiDi>B-06974785750372</basicUdiDi>
    <tradeName>Rotavirus Rapid Test (Feces)</tradeName>
    <deviceName>Rotavirus Rapid Test (Feces)</deviceName>
    <manufacturerName>Anhui Formaster Biosci Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002305</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IRO-3013</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:43:02.447Z</lastUpdated>
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    <udiDi>06974735360927</udiDi>
    <basicUdiDi>B-06974735360927</basicUdiDi>
    <tradeName>KEYU Rotavirus/Adenovirus Antigen  Rapid Test (Colloidal Gold)</tradeName>
    <deviceName>Rotavirus/Adenovirus Antigen  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>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RV/ADV-R-G</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:33:53.693Z</lastUpdated>
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    <udiDi>06974735360910</udiDi>
    <basicUdiDi>B-06974735360910</basicUdiDi>
    <tradeName>KEYU Rotavirus Group A Antigen Rapid Test (Colloidal Gold)</tradeName>
    <deviceName>Rotavirus Group A Antigen 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>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RV-R-F</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:33:49.675Z</lastUpdated>
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    <udiDi>06974735360774</udiDi>
    <basicUdiDi>B-06974735360774</basicUdiDi>
    <tradeName>KEYU Rotavirus Group A/Adenovirus Antigen 2in1 Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Rotavirus Group A/Adenovirus Antigen 2in1 Test Kit (Colloidal Gold)</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>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RV/ADV-I</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:33:34.460Z</lastUpdated>
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    <udiDi>06974735360767</udiDi>
    <basicUdiDi>B-06974735360767</basicUdiDi>
    <tradeName>KEYU Rotavirus (RV) Group A Antigen Test Kit (Colloidal gold method)</tradeName>
    <deviceName>Rotavirus (RV) Group A Antigen Test 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>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARV-I</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:33:30.962Z</lastUpdated>
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    <udiDi>06974735360637</udiDi>
    <basicUdiDi>B-06974735360637</basicUdiDi>
    <tradeName>KEYU Rotavirus Group A/Adenovirus Antigen 2in1 Test Kit (Colloidal Gold)</tradeName>
    <deviceName>Rotavirus Group A/Adenovirus Antigen 2in1 Test Kit (Colloidal Gold)</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>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RV/ADV-III</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:33:22.457Z</lastUpdated>
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    <udiDi>06974735360620</udiDi>
    <basicUdiDi>B-06974735360620</basicUdiDi>
    <tradeName>KEYU Rotavirus (RV) Group A Antigen Test Kit (Colloidal gold method)</tradeName>
    <deviceName>Rotavirus (RV) Group A Antigen Test 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>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARV-III</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:33:21.652Z</lastUpdated>
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    <udiDi>06974735360392</udiDi>
    <basicUdiDi>B-06974735360392</basicUdiDi>
    <tradeName>KEYU Rotavirus (RV) Group A Antigen Test Kit (Colloidal gold method)</tradeName>
    <deviceName>Rotavirus (RV) Group A Antigen Test 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>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARV-II</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:32:41.570Z</lastUpdated>
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    <udiDi>06974735360231</udiDi>
    <basicUdiDi>B-06974735360231</basicUdiDi>
    <tradeName>KEYU Rotavirus/Adenovirus Antigen  Rapid Test (Colloidal Gold)</tradeName>
    <deviceName>Rotavirus/Adenovirus Antigen  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>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RV/ADV-R-F</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:32:33.564Z</lastUpdated>
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    <basicUdiDi>B-06974735360224</basicUdiDi>
    <tradeName>KEYU Rotavirus Group A Antigen Rapid Test (Colloidal Gold)</tradeName>
    <deviceName>Rotavirus Group A Antigen 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>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RV-R-G</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:32:32.770Z</lastUpdated>
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    <udiDi>06974566302967</udiDi>
    <basicUdiDi>B-06974566302967</basicUdiDi>
    <tradeName>Rotavirus Group A Antigen Rapid Test</tradeName>
    <deviceName>Rotavirus Group A Antigen Rapid Test</deviceName>
    <manufacturerName>Zhuhai Encode Medical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019361</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W0105040606</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:53:59.331Z</lastUpdated>
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    <basicUdiDi>B-06974238910377</basicUdiDi>
    <tradeName>Rotavirus Antigen Rapid Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Immuno Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001118</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040606</emdnCode>
    <emdnDescription>ROTAVIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HROTA027G</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:58:28.509Z</lastUpdated>
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    <basicUdiDi>594476025TESTERAPIDEUY</basicUdiDi>
    <tradeName>AFP RAPID TEST CASSETTE (WHOLE BLOOD/SERUM/PLASMA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tody Laboratories Int. SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000032726</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0105040606</emdnCode>
    <emdnDescription>ALPHAFETOPROTEIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C61RT1027</reference>
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    <tradeName>TSH RAPID TEST CASSETTE (WHOLE BLOOD/SERUM/PLASMA)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tody Laboratories Int. SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000032726</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0105040606</emdnCode>
    <emdnDescription>THYROID STIMULATING HORMONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C61RT1001</reference>
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    <lastUpdated>2026-07-05T04:10:18.766Z</lastUpdated>
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