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    <basicUdiDi>B-06974671100342</basicUdiDi>
    <tradeName>06974671100342</tradeName>
    <deviceName>Phenylalanine (Phe) Diagnostic Kit (Fluorometric Assay)</deviceName>
    <manufacturerName>Darui Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000030310</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010236</emdnCode>
    <emdnDescription>PHENYLKETONURIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DR-NS-A002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T17:07:01.623Z</lastUpdated>
  </row>
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    <udiDi>04049325004573</udiDi>
    <basicUdiDi>B-04049325004573</basicUdiDi>
    <tradeName>Phenylalanine (PKU) neonatal Screening Assay</tradeName>
    <deviceName>Phenylalanine (PKU) neonatal Screening Assay</deviceName>
    <manufacturerName>IBL International GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000015709</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010236</emdnCode>
    <emdnDescription>PHENYLKETONURIA</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>RE80019</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:10:04.607Z</lastUpdated>
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  <row>
    <udiDi>06438172085015</udiDi>
    <basicUdiDi>B-06438172085015</basicUdiDi>
    <tradeName>Neonatal Phenylalanine</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Labsystems Diagnostics Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000018281</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010236</emdnCode>
    <emdnDescription>PHENYLKETONURIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6199896</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:39:59.299Z</lastUpdated>
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    <udiDi>06438147324514</udiDi>
    <basicUdiDi>B-06438147324514</basicUdiDi>
    <tradeName>GSP Neonatal Phenylalanine kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010236</emdnCode>
    <emdnDescription>PHENYLKETONURIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3308-0010</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:36:03.531Z</lastUpdated>
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    <udiDi>06438147324507</udiDi>
    <basicUdiDi>B-06438147324507</basicUdiDi>
    <tradeName>GSP Neonatal Phenylalanine kit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010236</emdnCode>
    <emdnDescription>PHENYLKETONURIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3308-001B</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:36:02.335Z</lastUpdated>
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  <row>
    <udiDi>06438147001293</udiDi>
    <basicUdiDi>B-06438147001293</basicUdiDi>
    <tradeName>Neonatal Phenylalanine</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010236</emdnCode>
    <emdnDescription>PHENYLKETONURIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NP-4000</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:34:13.083Z</lastUpdated>
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  <row>
    <udiDi>06438147001286</udiDi>
    <basicUdiDi>B-06438147001286</basicUdiDi>
    <tradeName>Neonatal Phenylalanine</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Wallac Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000022620</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W01010236</emdnCode>
    <emdnDescription>PHENYLKETONURIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NP-1000</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-06-23T08:34:11.914Z</lastUpdated>
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