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    <tradeName>Pefakit® APC-R Factor V Leiden Controls</tradeName>
    <deviceName>Pefakit® APC-R Factor V Leiden Controls</deviceName>
    <manufacturerName>Pentapharm AG</manufacturerName>
    <manufacturerSrn>CH-MF-000020620</manufacturerSrn>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>APC RESISTANCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>502-21</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:44:03.913Z</lastUpdated>
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    <tradeName>Pefakit® APC-R Faktor V Leiden</tradeName>
    <deviceName>Pefakit® APC-R Factor V Leiden</deviceName>
    <manufacturerName>Pentapharm AG</manufacturerName>
    <manufacturerSrn>CH-MF-000020620</manufacturerSrn>
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    <emdnDescription>APC RESISTANCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:44:03.108Z</lastUpdated>
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    <udiDi>07613336155448</udiDi>
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    <tradeName>APCr</tradeName>
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    <manufacturerName>Pentapharm AG</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>08013934190</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-07T01:49:01.117Z</lastUpdated>
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    <udiDi>03607450007213</udiDi>
    <basicUdiDi>B-03607450007213</basicUdiDi>
    <tradeName>STA® - Staclot® APC-R</tradeName>
    <deviceName>STA® - Staclot® APC-R</deviceName>
    <manufacturerName>Diagnostica Stago</manufacturerName>
    <manufacturerSrn>FR-MF-000017089</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0103020610</emdnCode>
    <emdnDescription>APC RESISTANCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>00721</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:58:23.389Z</lastUpdated>
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    <udiDi>08426950062424</udiDi>
    <basicUdiDi>84269500624246C</basicUdiDi>
    <tradeName>HemosIL Factor V Leiden (APC Resistance V)</tradeName>
    <deviceName>HemosIL Factor V Leiden (APC Resistance V)</deviceName>
    <manufacturerName>Instrumentation Laboratory Company</manufacturerName>
    <manufacturerSrn>US-MF-000035586</manufacturerSrn>
    <authorisedRepresentativeName>Instrumentation Laboratory SpA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000008169</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020610</emdnCode>
    <emdnDescription>APC RESISTANCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0020008700</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:03:45.047Z</lastUpdated>
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    <udiDi>07640175460099</udiDi>
    <basicUdiDi>76401754608013934190QZ</basicUdiDi>
    <tradeName>APCr</tradeName>
    <deviceName>APC Resistance</deviceName>
    <manufacturerName>Pentapharm AG</manufacturerName>
    <manufacturerSrn>CH-MF-000020620</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103020610</emdnCode>
    <emdnDescription>APC RESISTANCE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08013934190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:39:47.299Z</lastUpdated>
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