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    <tradeName>Atellica CH Phencyclidine (Pcp)</tradeName>
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    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <lastUpdated>2026-07-15T21:35:01.746Z</lastUpdated>
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    <udiDi>00842768001956</udiDi>
    <basicUdiDi>0405686901158VE</basicUdiDi>
    <tradeName>Emit II Plus Phencyclidine Assay</tradeName>
    <deviceName>IVDR_67_GLA_DUB-C_B_REAG_Phencyclidine Assay</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016336</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
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    <udiDi>D-PCP-05-25tNA</udiDi>
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    <tradeName>Singclean®</tradeName>
    <deviceName>Phencyclidine (PCP) One Step Test Kit (Colloidal Gold Method)</deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
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    <udiDi>D-PCP-02-25tM9</udiDi>
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    <tradeName>Singclean</tradeName>
    <deviceName>Phencyclidine (PCP) One Step Test Kit (Colloidal Gold Method)</deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCP-02-25t</reference>
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    <udiDi>D-PCP-01-100t9Q</udiDi>
    <basicUdiDi>B-PCP-01-100t9Q</basicUdiDi>
    <tradeName>Singclean</tradeName>
    <deviceName>Phencyclidine (PCP) One Step Test Kit (Colloidal Gold Method)</deviceName>
    <manufacturerName>Hangzhou Singclean Medical Products Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014098</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <emdnDescription>PHENCYCLIDINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCP-01-100t</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-14T06:12:10.132Z</lastUpdated>
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    <udiDi>00842768001963</udiDi>
    <basicUdiDi>0405686901158VE</basicUdiDi>
    <tradeName>Emit II Plus Phencyclidine 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>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090114</emdnCode>
    <emdnDescription>PHENCYCLIDINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10445443</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>00842768014406</udiDi>
    <basicUdiDi>0405686901158VE</basicUdiDi>
    <tradeName>Emit II Plus Phencyclidine 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>
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    <emdnDescription>PHENCYCLIDINE</emdnDescription>
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    <reference>10445442</reference>
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    <lastUpdated>2026-07-13T19:55:28.778Z</lastUpdated>
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    <udiDi>D-475009QD</udiDi>
    <basicUdiDi>B-475009QD</basicUdiDi>
    <tradeName>Phencyclidine Reagent (PCP 1 x 250)</tradeName>
    <deviceName>Phencyclidine Reagent (PCP 1 x 250)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102090114</emdnCode>
    <emdnDescription>PHENCYCLIDINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>475009</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:05:25.952Z</lastUpdated>
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    <udiDi>00630414654232</udiDi>
    <basicUdiDi>0405686901757WA</basicUdiDi>
    <tradeName>Atellica CH Phencyclidine (PcpC)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090114</emdnCode>
    <emdnDescription>PHENCYCLIDINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>11701334</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:51:10.695Z</lastUpdated>
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    <udiDi>06974854620971</udiDi>
    <basicUdiDi>B-06974854620971</basicUdiDi>
    <tradeName>Phencyclidine (PCP) Rapid Test</tradeName>
    <deviceName>Phencyclidine (PCP) Rapid Test</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>W0102090114</emdnCode>
    <emdnDescription>PHENCYCLIDINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P22047</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:54:06.763Z</lastUpdated>
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    <udiDi>06974566302998</udiDi>
    <basicUdiDi>B-06974566302998</basicUdiDi>
    <tradeName>Phencyclidine(PCP)  Rapid Test</tradeName>
    <deviceName>Phencyclidine(PCP)  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>W0102090114</emdnCode>
    <emdnDescription>PHENCYCLIDINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DPC-105</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:54:03.332Z</lastUpdated>
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    <udiDi>06974473306171</udiDi>
    <basicUdiDi>B-06974473306171</basicUdiDi>
    <tradeName>TCA Rapid Test Kit (Colloidal gold method)</tradeName>
    <deviceName>TCA 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>DP023</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T16:11:26.308Z</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>00884883011359</udiDi>
    <basicUdiDi>B-00884883011359</basicUdiDi>
    <tradeName>00884883011359</tradeName>
    <deviceName>DRI Phencyclidine Assay</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>
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    <emdnCode>W0102090114</emdnCode>
    <emdnDescription>PHENCYCLIDINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10014673</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:30:22.279Z</lastUpdated>
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    <udiDi>00884883011106</udiDi>
    <basicUdiDi>B-00884883011106</basicUdiDi>
    <tradeName>00884883011106</tradeName>
    <deviceName>CEDIA Phencyclidine (PCP) OFT Assay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>10014888</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:29:50.250Z</lastUpdated>
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    <udiDi>00884883008878</udiDi>
    <basicUdiDi>B-00884883008878</basicUdiDi>
    <tradeName>00884883008878</tradeName>
    <deviceName>Alinity c Phencyclidine</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>09P6620</reference>
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    <lastUpdated>2026-07-05T09:29:07.779Z</lastUpdated>
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    <udiDi>00884883008380</udiDi>
    <basicUdiDi>B-00884883008380</basicUdiDi>
    <tradeName>00884883008380</tradeName>
    <deviceName>ARCHITECT Phencyclidine</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <emdnDescription>PHENCYCLIDINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6L96-20</reference>
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    <lastUpdated>2026-07-05T09:28:13.450Z</lastUpdated>
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    <basicUdiDi>B-00884883004344</basicUdiDi>
    <tradeName>00884883004344</tradeName>
    <deviceName>CEDIA Phencyclidine (PCP) Assay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
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    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-05T09:19:59.052Z</lastUpdated>
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    <tradeName>00884883004276</tradeName>
    <deviceName>CEDIA Phencyclidine (PCP) Assay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-05T09:19:47.823Z</lastUpdated>
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    <tradeName>00884883003422</tradeName>
    <deviceName>DRI Phencyclidine Assay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>0160</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:16:10.870Z</lastUpdated>
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