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    <tradeName>MTD Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>MTD Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090110</emdnCode>
    <emdnDescription>METHADONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP014</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:10:36.623Z</lastUpdated>
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    <udiDi>06974473302951</udiDi>
    <basicUdiDi>B-06974473302951</basicUdiDi>
    <tradeName>APAP Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>APAP Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090201</emdnCode>
    <emdnDescription>ACETAMINOPHENE (PARACETAMOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP028</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:10:31.020Z</lastUpdated>
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    <udiDi>06974473302784</udiDi>
    <basicUdiDi>B-06974473302784</basicUdiDi>
    <tradeName>K2 Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>K2 Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP026</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:10:30.218Z</lastUpdated>
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    <udiDi>06974473302715</udiDi>
    <basicUdiDi>B-06974473302715</basicUdiDi>
    <tradeName>ALC Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>ALC Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090207</emdnCode>
    <emdnDescription>ETHANOL (ALCOHOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP019</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:10:25.415Z</lastUpdated>
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    <udiDi>06974473302401</udiDi>
    <basicUdiDi>B-06974473302401</basicUdiDi>
    <tradeName>KET Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>KET Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP004</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:10:23.829Z</lastUpdated>
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    <udiDi>06974473302395</udiDi>
    <basicUdiDi>B-06974473302395</basicUdiDi>
    <tradeName>COC Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>COC Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090106</emdnCode>
    <emdnDescription>COCAINE + COCAINE METABOLITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP008</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:10:19.823Z</lastUpdated>
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    <udiDi>06974473302197</udiDi>
    <basicUdiDi>B-06974473302197</basicUdiDi>
    <tradeName>BAR/BZO/MOP Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>BAR/BZO/MOP Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:10:19.015Z</lastUpdated>
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    <udiDi>06974473301701</udiDi>
    <basicUdiDi>B-06974473301701</basicUdiDi>
    <tradeName>MQL Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>MQL Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090111</emdnCode>
    <emdnDescription>METHAQUALONE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP017</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:10:13.418Z</lastUpdated>
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    <udiDi>06974473301626</udiDi>
    <basicUdiDi>B-06974473301626</basicUdiDi>
    <tradeName>MET  Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>MET  Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090102</emdnCode>
    <emdnDescription>AMPHETAMINE/METHAMPHETAMINE SPECIFIC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP005</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:10:12.626Z</lastUpdated>
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    <udiDi>06974473301596</udiDi>
    <basicUdiDi>B-06974473301596</basicUdiDi>
    <tradeName>MOP/MET/MDMA Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>MOP/MET/MDMA Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP011</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:10:11.820Z</lastUpdated>
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    <udiDi>06974473301039</udiDi>
    <basicUdiDi>B-06974473301039</basicUdiDi>
    <tradeName>MOP/MET/KET/MDMA/THC/COC Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>MOP/MET/KET/MDMA/THC/COC Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP012</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:10:06.216Z</lastUpdated>
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    <udiDi>06974473300742</udiDi>
    <basicUdiDi>B-06974473300742</basicUdiDi>
    <tradeName>COT Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>COT Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090108</emdnCode>
    <emdnDescription>COTININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP015</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:10:04.712Z</lastUpdated>
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    <udiDi>06974473300483</udiDi>
    <basicUdiDi>B-06974473300483</basicUdiDi>
    <tradeName>PCP Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>PCP Rapid Test Kit (Colloidal gold method)</deviceName>
    <manufacturerName>Nanjing Synthgene Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000023810</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090114</emdnCode>
    <emdnDescription>PHENCYCLIDINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DP021</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:09:53.422Z</lastUpdated>
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    <udiDi>06974238910605</udiDi>
    <basicUdiDi>B-06974238910605</basicUdiDi>
    <tradeName>Oral Fluid Multi-Panel Drug Test Cup</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>W0102090105</emdnCode>
    <emdnDescription>CANNABINOIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N0FMP052C</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:59:14.987Z</lastUpdated>
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    <udiDi>06974238910599</udiDi>
    <basicUdiDi>B-06974238910599</basicUdiDi>
    <tradeName>Oral Fluid Multi-Panel Drug Test Kit (THC/AMP/ OPI/MET/COC /BZO)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Immuno Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001118</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090105</emdnCode>
    <emdnDescription>CANNABINOIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NOFMP051K</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:59:10.984Z</lastUpdated>
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    <udiDi>06974238910582</udiDi>
    <basicUdiDi>B-06974238910582</basicUdiDi>
    <tradeName>Cotinine (COT) Rapid Test (Saliva)</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>W0102090108</emdnCode>
    <emdnDescription>COTININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCOT050S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:59:10.185Z</lastUpdated>
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    <udiDi>06974238910575</udiDi>
    <basicUdiDi>B-06974238910575</basicUdiDi>
    <tradeName>Multi-Drug BecelCup Test Cup (Urine)</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>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HMDRO49B</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:59:09.389Z</lastUpdated>
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    <udiDi>06974238910568</udiDi>
    <basicUdiDi>B-06974238910568</basicUdiDi>
    <tradeName>Multi-Drug LazyCup Test Cup (Urine)</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>W0102090215</emdnCode>
    <emdnDescription>TRICYCLIC ANTIDEPRESSANTS (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HMDR048L</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:59:08.593Z</lastUpdated>
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    <udiDi>06974238910551</udiDi>
    <basicUdiDi>B-06974238910551</basicUdiDi>
    <tradeName>Multi-Drug Test Panel (Urine)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hangzhou Immuno Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001118</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090215</emdnCode>
    <emdnDescription>TRICYCLIC ANTIDEPRESSANTS (TOTAL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HMDR047</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:59:04.737Z</lastUpdated>
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    <udiDi>06974238910544</udiDi>
    <basicUdiDi>B-06974238910544</basicUdiDi>
    <tradeName>Cotinine (COT) Rapid Test (Saliva)</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>W0102090108</emdnCode>
    <emdnDescription>COTININE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCOT050S</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T14:59:04.704Z</lastUpdated>
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