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    <deviceName>Batroxobin Time</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>W0103020103</emdnCode>
    <emdnDescription>THROMBIN TIME / REPTILASE / BATROXBIN TIME</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09134867190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
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    <tradeName>APCr Controls</tradeName>
    <deviceName>APC Resistance Controls</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>W0103020702</emdnCode>
    <emdnDescription>CONTROL PLASMA FOR HAEMOSTASIS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08045232190</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:39:48.905Z</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>
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    <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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    <udiDi>07613336155448</udiDi>
    <basicUdiDi>B-07613336155448</basicUdiDi>
    <tradeName>APCr</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pentapharm AG</manufacturerName>
    <manufacturerSrn>CH-MF-000020620</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08013934190</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T06:33:10.971Z</lastUpdated>
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    <udiDi>07613336155455</udiDi>
    <basicUdiDi>B-07613336155455</basicUdiDi>
    <tradeName>APCr Controls</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pentapharm AG</manufacturerName>
    <manufacturerSrn>CH-MF-000020620</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08045232190</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T06:33:10.950Z</lastUpdated>
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    <udiDi>07640175460037</udiDi>
    <basicUdiDi>B-07640175460037</basicUdiDi>
    <tradeName>Batroxobin Time</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pentapharm AG</manufacturerName>
    <manufacturerSrn>CH-MF-000020620</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>09134867190</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:51:16.876Z</lastUpdated>
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    <udiDi>07640175460044</udiDi>
    <basicUdiDi>B-07640175460044</basicUdiDi>
    <tradeName>Pefakit® APC-R Faktor V Leiden</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pentapharm AG</manufacturerName>
    <manufacturerSrn>CH-MF-000020620</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>502-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:51:16.859Z</lastUpdated>
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    <udiDi>07640175460051</udiDi>
    <basicUdiDi>B-07640175460051</basicUdiDi>
    <tradeName>Pefakit® APC-R Factor V Leiden Controls</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pentapharm AG</manufacturerName>
    <manufacturerSrn>CH-MF-000020620</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>502-21</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:51:16.838Z</lastUpdated>
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    <udiDi>07640175460068</udiDi>
    <basicUdiDi>B-07640175460068</basicUdiDi>
    <tradeName>Pefaclot® UFH</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pentapharm AG</manufacturerName>
    <manufacturerSrn>CH-MF-000020620</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>505-50</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:51:16.818Z</lastUpdated>
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    <udiDi>07640175460075</udiDi>
    <basicUdiDi>B-07640175460075</basicUdiDi>
    <tradeName>Pefaclot®  UFH Controls</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pentapharm AG</manufacturerName>
    <manufacturerSrn>CH-MF-000020620</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>505-60</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:51:16.799Z</lastUpdated>
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    <udiDi>07640175460082</udiDi>
    <basicUdiDi>B-07640175460082</basicUdiDi>
    <tradeName>Pefakit® Reptilase® Time</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Pentapharm AG</manufacturerName>
    <manufacturerSrn>CH-MF-000020620</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>800191</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T05:51:16.785Z</lastUpdated>
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