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    <tradeName>IDK® Zonulin ELISA</tradeName>
    <deviceName>IDK® Zonulin ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <lastUpdated>2026-07-31T12:25:37.512Z</lastUpdated>
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    <udiDi>04050598162105</udiDi>
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    <tradeName>β2-Mikroglobulin ELISA</tradeName>
    <deviceName>β2-Mikroglobulin ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
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    <tradeName>β-Defensin 2 ELISA</tradeName>
    <deviceName>β-Defensin 2 ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
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    <tradeName>L-Citrullin</tradeName>
    <deviceName>L-Citrullin</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6600</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:37.266Z</lastUpdated>
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    <udiDi>04050598168114</udiDi>
    <basicUdiDi>B-04050598168114</basicUdiDi>
    <tradeName>IDK® EDN ELISA</tradeName>
    <deviceName>IDK® EDN ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6811</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:37.107Z</lastUpdated>
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    <udiDi>04050598169388</udiDi>
    <basicUdiDi>B-04050598169388</basicUdiDi>
    <tradeName>IDK® S100A12 ELISA</tradeName>
    <deviceName>IDK® S100A12 ELISA</deviceName>
    <manufacturerName>Immundiagnostik AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020905</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K 6938</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T12:25:36.896Z</lastUpdated>
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    <udiDi>05056013025689</udiDi>
    <basicUdiDi>505601300ULTCESPE6</basicUdiDi>
    <tradeName>UltraCE Serum Protein</tradeName>
    <deviceName>UltraCE Serum Protein</deviceName>
    <manufacturerName>Helena Biosciences Europe</manufacturerName>
    <manufacturerSrn>GB-MF-000028365</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V8100</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:22:07.666Z</lastUpdated>
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    <tradeName>SAS-MX SP-10 Kit</tradeName>
    <deviceName>Serum Protein Kits</deviceName>
    <manufacturerName>Helena Biosciences Europe</manufacturerName>
    <manufacturerSrn>GB-MF-000028365</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
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    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
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    <tradeName>DNlite-IVD103</tradeName>
    <deviceName>DNlite uPTM-FetA ELISA Kit</deviceName>
    <manufacturerName>Bio Preventive Medicine Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000022845</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8103106 (4oC)</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:46:42.406Z</lastUpdated>
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    <basicUdiDi>471987949E103017J</basicUdiDi>
    <tradeName>DNlite-IVD103</tradeName>
    <deviceName>DNlite uPTM-FetA ELISA Kit</deviceName>
    <manufacturerName>Bio Preventive Medicine Corp.</manufacturerName>
    <manufacturerSrn>TW-MF-000022845</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>8103106 (-20oC)</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:39:37.512Z</lastUpdated>
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    <udiDi>15099590224028</udiDi>
    <basicUdiDi>150995901447750LP</basicUdiDi>
    <tradeName>IMMAGE Immunochemistry Systems AT3 Antithrombin III Reagent</tradeName>
    <deviceName>IMMAGE Immunochemistry Systems AT3 Antithrombin III Reagent</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102019099</emdnCode>
    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>447750</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:33:27.613Z</lastUpdated>
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    <udiDi>15099590020392</udiDi>
    <basicUdiDi>150995901OSR6299N5</basicUdiDi>
    <tradeName>CRP Latex</tradeName>
    <deviceName>CRP Latex</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6299</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:30:14.561Z</lastUpdated>
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    <basicUdiDi>150995901OSR61203SK</basicUdiDi>
    <tradeName>Ferritin</tradeName>
    <deviceName>Ferritin</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR61203</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:29:28.905Z</lastUpdated>
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    <tradeName>CRP Latex</tradeName>
    <deviceName>CRP Latex</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <emdnDescription>SPECIFIC PROTEINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6199</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:29:16.128Z</lastUpdated>
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    <tradeName>Anti-Streptolysin O (ASO)</tradeName>
    <deviceName>Anti-Streptolysin O (ASO)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6194</reference>
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    <lastUpdated>2026-07-30T17:29:12.081Z</lastUpdated>
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    <tradeName>Myoglobin</tradeName>
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    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
    <manufacturerSrn>IE-MF-000000887</manufacturerSrn>
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    <reference>OSR6168</reference>
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    <tradeName>a-1-ANTITRYPSIN</tradeName>
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    <manufacturerName>Beckman Coulter Ireland Inc.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR6163</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:28:49.638Z</lastUpdated>
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    <tradeName>β-2 Microglobulin (β-2 M)</tradeName>
    <deviceName>β-2 Microglobulin (β-2 M)</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
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    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>OSR60135</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T17:27:42.255Z</lastUpdated>
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