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    <basicUdiDi>B-00884883002005</basicUdiDi>
    <tradeName>00884883002005</tradeName>
    <deviceName>CEDIA Multi-Drug Intermediate Calibrator</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1730380</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:14:13.901Z</lastUpdated>
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    <udiDi>00884883001961</udiDi>
    <basicUdiDi>B-00884883001961</basicUdiDi>
    <tradeName>00884883001961</tradeName>
    <deviceName>CEDIA Negative Calibrator</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1661388</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:14:07.489Z</lastUpdated>
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    <udiDi>00884883001138</udiDi>
    <basicUdiDi>B-00884883001138</basicUdiDi>
    <tradeName>00884883001138</tradeName>
    <deviceName>DRI Serum Tox Calibrator 4</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0976</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:11:55.340Z</lastUpdated>
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    <udiDi>00884883001121</udiDi>
    <basicUdiDi>B-00884883001121</basicUdiDi>
    <tradeName>00884883001121</tradeName>
    <deviceName>DRI Serum Tox Calibrator 3</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0967</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:11:54.526Z</lastUpdated>
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    <udiDi>00884883001107</udiDi>
    <basicUdiDi>B-00884883001107</basicUdiDi>
    <tradeName>00884883001107</tradeName>
    <deviceName>DRI Serum Tox Calibrator 1</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0963</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:11:50.544Z</lastUpdated>
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    <udiDi>00884883001091</udiDi>
    <basicUdiDi>B-00884883001091</basicUdiDi>
    <tradeName>00884883001091</tradeName>
    <deviceName>DRI Serum Tox Negative Calibrator</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0962</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:11:48.926Z</lastUpdated>
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    <udiDi>00884883001039</udiDi>
    <basicUdiDi>B-00884883001039</basicUdiDi>
    <tradeName>00884883001039</tradeName>
    <deviceName>DRI 300 mg/dL Alcohol Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0243</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:11:42.537Z</lastUpdated>
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    <udiDi>00884883001015</udiDi>
    <basicUdiDi>B-00884883001015</basicUdiDi>
    <tradeName>00884883001015</tradeName>
    <deviceName>DRI 50 mg/dL Alcohol Control</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000026031</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0239</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:11:26.463Z</lastUpdated>
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    <udiDi>00812101030134</udiDi>
    <basicUdiDi>B-00812101030134</basicUdiDi>
    <tradeName>ARK Meperidine Assay</tradeName>
    <deviceName>ARK Meperidine Assay</deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5039-0001-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:21:04.587Z</lastUpdated>
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    <udiDi>00812101030127</udiDi>
    <basicUdiDi>B-00812101030127</basicUdiDi>
    <tradeName>ARK Meperidine Assay</tradeName>
    <deviceName>ARK Meperidine Assay</deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5039-0001-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T17:21:03.806Z</lastUpdated>
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    <udiDi>08426950553618</udiDi>
    <basicUdiDi>84269505536188Q</basicUdiDi>
    <tradeName>DRI Ecstasy</tradeName>
    <deviceName>DRI Ecstasy</deviceName>
    <manufacturerName>Instrumentation Laboratory SpA</manufacturerName>
    <manufacturerSrn>IT-MF-000009277</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W15100075</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:06:41.317Z</lastUpdated>
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    <udiDi>06936020140416</udiDi>
    <basicUdiDi>69360201528X</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName>Multi-Drug One Step Test Kit (Colloidal Gold Method) (BZO/BAR/MDMA/MTD/OXY)</deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M90-05-25t</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:44.191Z</lastUpdated>
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    <udiDi>06936020140386</udiDi>
    <basicUdiDi>69360201118H</basicUdiDi>
    <tradeName>Singclean®</tradeName>
    <deviceName>Multi-Drug One Step Test Kit (Colloidal Gold Method)(COC/AMP/MET/MOP/THC)</deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M61-05-25t</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T07:04:43.394Z</lastUpdated>
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    <udiDi>06952804817534</udiDi>
    <basicUdiDi>B-06952804817534</basicUdiDi>
    <tradeName>Tilidin Rapid Test</tradeName>
    <deviceName>Tilidin Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</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>TLD-U11 TLD-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:31:27.756Z</lastUpdated>
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    <udiDi>06952804817497</udiDi>
    <basicUdiDi>B-06952804817497</basicUdiDi>
    <tradeName>Zaleplon Rapid Test</tradeName>
    <deviceName>Zaleplon Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</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>ZAL-U11 ZAL-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:31:21.756Z</lastUpdated>
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    <udiDi>06952804803681</udiDi>
    <basicUdiDi>B-06952804803681</basicUdiDi>
    <tradeName>Fentanyl FIA</tradeName>
    <deviceName>Fentanyl FIA</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</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>FYL-U23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:25:23.534Z</lastUpdated>
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    <udiDi>06952804803643</udiDi>
    <basicUdiDi>B-06952804803643</basicUdiDi>
    <tradeName>MDMA FIA</tradeName>
    <deviceName>MDMA FIA</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</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>MDMA-H23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:25:21.175Z</lastUpdated>
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    <udiDi>06952804803490</udiDi>
    <basicUdiDi>B-06952804803490</basicUdiDi>
    <tradeName>Ketamine FIA</tradeName>
    <deviceName>Ketamine FIA</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</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>KET-H23F3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:25:02.199Z</lastUpdated>
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    <udiDi>06952804802943</udiDi>
    <basicUdiDi>B-06952804802943</basicUdiDi>
    <tradeName>Cathine Rapid Test</tradeName>
    <deviceName>Cathine Rapid Test</deviceName>
    <manufacturerName>Assure Tech. (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000002170</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>CAT-U23</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-06-28T09:23:35.945Z</lastUpdated>
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    <udiDi>06950996098434</udiDi>
    <basicUdiDi>69509960GBDOA144008ZL</basicUdiDi>
    <tradeName>One Step Multi-Drug Test Dip Card (Urine)</tradeName>
    <deviceName>One Step Multi-Drug Test Dip Card (Urine)</deviceName>
    <manufacturerName>Zhejiang Orient Gene Biotech Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000017965</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GBDOA-144-008</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-06-28T06:34:39.879Z</lastUpdated>
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