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    <deviceName>CEDIA Bupernorphine II 20ng/mL Calibrator</deviceName>
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    <deviceName>CEDIA Bupernorphine II 50ng/mL Calibrator</deviceName>
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    <deviceName>CEDIA Bupernorphine II 100ng/mL Calibrator</deviceName>
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    <deviceName>CEDIA Bupernorphine II Controls</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
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    <tradeName>00884883004757</tradeName>
    <deviceName>CEDIA Bupernorphine II Assay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
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    <deviceName>CEDIA Bupernorphine II Assay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
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    <deviceName>CEDIA Bupernorphine II 10ng/mL Calibrator</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
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    <deviceName>CEDIA Buprenorphine Controls</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
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    <deviceName>CEDIA Buprenorphine 75 ng/mL Calibrator</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <emdnDescription>BUPRENORPHINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <tradeName>00884883001732</tradeName>
    <deviceName>CEDIA Buprenorphine 50 ng/mL Calibrator</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <emdnDescription>BUPRENORPHINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>100244</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:13:25.832Z</lastUpdated>
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    <deviceName>CEDIA Buprenorphine 20 ng/mL Calibrator</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
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    <deviceName>CEDIA Buprenorphine 5 ng/mL Calibrator</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <deviceName>CEDIA Buprenorphine 0 ng/mL Calibrator</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000030375</manufacturerSrn>
    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <emdnDescription>BUPRENORPHINE</emdnDescription>
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    <deviceName>CEDIA Buprenorphine Assay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
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    <authorisedRepresentativeName>B·R·A·H·M·S GmbH</authorisedRepresentativeName>
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    <emdnDescription>BUPRENORPHINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>B-00884883001602</basicUdiDi>
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    <deviceName>CEDIA Buprenorphine Assay</deviceName>
    <manufacturerName>Microgenics Corporation</manufacturerName>
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    <emdnDescription>BUPRENORPHINE</emdnDescription>
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    <tradeName>Buprenorphine Rapid Test</tradeName>
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    <emdnDescription>BUPRENORPHINE</emdnDescription>
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    <reference>BUP-U11 BUP-U23</reference>
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    <deviceName>Buprenorphine Panel Test Drugs of Abuse Test Kit</deviceName>
    <manufacturerName>Beijing Diagreat Biotechnologies Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000019511</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102090117</emdnCode>
    <emdnDescription>BUPRENORPHINE</emdnDescription>
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    <reference>G12713</reference>
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    <tradeName>Buprenorphine （BUP ）Rapid Test（Urine）</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Xiamen Biotime Biotechnology Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
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    <reference>BT0104801</reference>
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    <tradeName>Atlas</tradeName>
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    <manufacturerSrn>DE-MF-000029961</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>W0102090117</emdnCode>
    <emdnDescription>BUPRENORPHINE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8.16.23.0.0100</reference>
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    <lastUpdated>2026-06-18T00:35:27.380Z</lastUpdated>
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