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    <tradeName>Emit II Plus Oxycodone Assay</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090123</emdnCode>
    <emdnDescription>OXYCODINE</emdnDescription>
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    <reference>10720816</reference>
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    <lastUpdated>2026-07-16T03:47:08.180Z</lastUpdated>
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    <basicUdiDi>0858724003EDDP0515Z</basicUdiDi>
    <tradeName>ARK EDDP Assay</tradeName>
    <deviceName>ARK EDDP Assay</deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5051-0001-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <udiDi>00858724003773</udiDi>
    <basicUdiDi>0858724003TRA0406V</basicUdiDi>
    <tradeName>ARK Tramadol Assay</tradeName>
    <deviceName>ARK Tramadol Assay</deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
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    <lastUpdated>2026-07-16T03:43:04.112Z</lastUpdated>
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    <basicUdiDi>0858724003MHP0423Z</basicUdiDi>
    <tradeName>ARK Methylphenidate Metabolite Assay</tradeName>
    <deviceName>ARK Methylphenidate Metabolite Assay</deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5042-0001-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:43:03.307Z</lastUpdated>
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    <udiDi>00858724003469</udiDi>
    <basicUdiDi>0858724003ETG03633</basicUdiDi>
    <tradeName>ARK Ethyl Glucuronide Assay</tradeName>
    <deviceName>ARK Ethyl Glucuronide 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 Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090220</emdnCode>
    <emdnDescription>ETHYL GLUCURONIDE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5036-0001-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:43:01.712Z</lastUpdated>
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    <udiDi>00812101032084</udiDi>
    <basicUdiDi>0858724003ETG0773H</basicUdiDi>
    <tradeName>ARK Ethyl Glucuronide II Assay</tradeName>
    <deviceName>ARK Ethyl Glucuronide II 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 Sınıf B</riskClass>
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    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5077-0001-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:38:38.941Z</lastUpdated>
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    <basicUdiDi>0858724003KET0833G</basicUdiDi>
    <tradeName>ARK Ketamine II Assay</tradeName>
    <deviceName>ARK Ketamine II Assay</deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5083-0001-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <basicUdiDi>0858724003ZPC04399</basicUdiDi>
    <tradeName>ARK Zopiclone Assay</tradeName>
    <deviceName>ARK Zopiclone Assay</deviceName>
    <manufacturerName>ARK Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000023925</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5043-0001-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:38:37.346Z</lastUpdated>
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    <udiDi>00812101030561</udiDi>
    <basicUdiDi>0858724003FEN069Y8</basicUdiDi>
    <tradeName>ARK Fentanyl II Assay</tradeName>
    <deviceName>ARK Fentanyl II 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 Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5069-0001-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:38:32.528Z</lastUpdated>
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    <udiDi>00812101030479</udiDi>
    <basicUdiDi>0858724003BZD0733F</basicUdiDi>
    <tradeName>ARK HS Benzodiazepine II Assay</tradeName>
    <deviceName>ARK HS Benzodiazepine II 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 Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090104</emdnCode>
    <emdnDescription>BENZODIAZEPINES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5073-0001-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:38:31.725Z</lastUpdated>
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    <udiDi>00812101030448</udiDi>
    <basicUdiDi>0858724003PGB0592C</basicUdiDi>
    <tradeName>ARK Pregabalin II Assay</tradeName>
    <deviceName>ARK Pregabalin II 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 Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090199</emdnCode>
    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5059-0001-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:38:30.930Z</lastUpdated>
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    <udiDi>00812101030349</udiDi>
    <basicUdiDi>0858724003ABP055V9</basicUdiDi>
    <tradeName>ARK AB-PINACA Assay</tradeName>
    <deviceName>ARK AB-PINACA 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 Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090105</emdnCode>
    <emdnDescription>CANNABINOIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5055-0001-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:38:26.933Z</lastUpdated>
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    <udiDi>00812101030240</udiDi>
    <basicUdiDi>0858724003URJ0549L</basicUdiDi>
    <tradeName>ARK UR-144/JWH-018 Assay</tradeName>
    <deviceName>ARK UR-144/JWH-018 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 Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090105</emdnCode>
    <emdnDescription>CANNABINOIDS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5054-0001-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:38:26.174Z</lastUpdated>
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    <basicUdiDi>0858724003KET0563D</basicUdiDi>
    <tradeName>ARK Ketamine Assay</tradeName>
    <deviceName>ARK Ketamine 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 Sınıf B</riskClass>
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    <emdnDescription>DRUGS OF ABUSE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5056-0001-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:38:25.908Z</lastUpdated>
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    <basicUdiDi>0850624008EIAFEN202MD</basicUdiDi>
    <tradeName>Fentanyl II Enzyme Immunoassay</tradeName>
    <deviceName>Fentanyl II Enzyme Immunoassay</deviceName>
    <manufacturerName>Lin-Zhi International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003373</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
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    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-16T03:33:32.378Z</lastUpdated>
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    <udiDi>00850624008568</udiDi>
    <basicUdiDi>0850624008EIAEtG30225</basicUdiDi>
    <tradeName>Ethyl Glucuronide III Enzyme Immunoassay</tradeName>
    <deviceName>Ethyl Glucuronide III Enzyme Immunoassay</deviceName>
    <manufacturerName>Lin-Zhi International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003373</manufacturerSrn>
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    <emdnDescription>ETHYL GLUCURONIDE</emdnDescription>
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    <reference>09976523190</reference>
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    <tradeName>Buprenorphine Enzyme Immunoassay</tradeName>
    <deviceName>Buprenorphine Enzyme Immunoassay</deviceName>
    <manufacturerName>Lin-Zhi International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003373</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>08362955190</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:33:09.897Z</lastUpdated>
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    <tradeName>6-Acetylmorphine Enzyme Immunoassay</tradeName>
    <deviceName>6-Acetylmorphine Enzyme Immunoassay</deviceName>
    <manufacturerName>Lin-Zhi International, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003373</manufacturerSrn>
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    <reference>08240035190</reference>
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    <lastUpdated>2026-07-16T03:33:08.294Z</lastUpdated>
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    <tradeName>Atellica CH Ethyl Alcohol (ETOH)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_ETOH</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090207</emdnCode>
    <emdnDescription>ETHANOL (ALCOHOL)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097501</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:35:08.436Z</lastUpdated>
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    <tradeName>Atellica CH Opiates (Op)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_OP_2</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
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    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090113</emdnCode>
    <emdnDescription>OPIATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11097502</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:35:07.650Z</lastUpdated>
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