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    <tradeName>Omlipo C3 Kit</tradeName>
    <deviceName>Omlipo C3 Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:27:10.761Z</lastUpdated>
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    <udiDi>06971225933746</udiDi>
    <basicUdiDi>B-06971225933746</basicUdiDi>
    <tradeName>Nephstar C3 Kit</tradeName>
    <deviceName>Nephstar C3 Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>COMPLEMENT COMPONENT C3/C3C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DK033</reference>
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    <lastUpdated>2026-07-06T09:27:07.347Z</lastUpdated>
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    <udiDi>06971225930738</udiDi>
    <basicUdiDi>B-06971225930738</basicUdiDi>
    <tradeName>Omlipo C1IN Kit</tradeName>
    <deviceName>Omlipo C1IN Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnDescription>COMPLEMENT COMPONENT C1 INHIBITOR</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP36050</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:22:23.664Z</lastUpdated>
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    <udiDi>06971225930721</udiDi>
    <basicUdiDi>B-06971225930721</basicUdiDi>
    <tradeName>Omlipo C4 Kit</tradeName>
    <deviceName>Omlipo C4 Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010205</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP34050</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:22:22.776Z</lastUpdated>
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    <udiDi>06971225930714</udiDi>
    <basicUdiDi>B-06971225930714</basicUdiDi>
    <tradeName>Omlipo C3 Kit</tradeName>
    <deviceName>Omlipo C3 Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010203</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C3/C3C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OP33050</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:22:21.164Z</lastUpdated>
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    <udiDi>06971225930424</udiDi>
    <basicUdiDi>B-06971225930424</basicUdiDi>
    <tradeName>GPP-100 C4 Kit</tradeName>
    <deviceName>GPP-100 C4 Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010205</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GP34020</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:21:26.672Z</lastUpdated>
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    <udiDi>06971225930417</udiDi>
    <basicUdiDi>B-06971225930417</basicUdiDi>
    <tradeName>GPP-100 C3 Kit</tradeName>
    <deviceName>GPP-100 C3 Kit</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010203</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C3/C3C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GP33020</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T09:21:22.666Z</lastUpdated>
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    <udiDi>05415168009737</udiDi>
    <basicUdiDi>B-05415168009737</basicUdiDi>
    <tradeName>Complement C4</tradeName>
    <deviceName>Complement C4</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010205</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C4TUR-L00/ATE</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:36:11.647Z</lastUpdated>
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    <udiDi>05415168006187</udiDi>
    <basicUdiDi>B-05415168006187</basicUdiDi>
    <tradeName>Complement C4</tradeName>
    <deviceName>Complement C4</deviceName>
    <manufacturerName>Diagam S.A.</manufacturerName>
    <manufacturerSrn>BE-MF-000022993</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010205</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C4TUR-H00/ALI</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:33:29.486Z</lastUpdated>
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    <udiDi>05051700010603</udiDi>
    <basicUdiDi>B-05051700010603</basicUdiDi>
    <tradeName>Human Complement C5 NL BINDARID™ Kit</tradeName>
    <deviceName>Human Complement C5 NL BINDARID™ Kit</deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010299</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RN027.3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:13:09.604Z</lastUpdated>
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    <udiDi>05051700010511</udiDi>
    <basicUdiDi>B-05051700010511</basicUdiDi>
    <tradeName>Human Complement C1q NL BINDARID™ Kit</tradeName>
    <deviceName>Human Complement C1q NL BINDARID™ Kit</deviceName>
    <manufacturerName>The Binding Site Group Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000036707</manufacturerSrn>
    <authorisedRepresentativeName>The Binding Site Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000034426</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010201</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C1Q</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RN020.3</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T05:13:08.800Z</lastUpdated>
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    <udiDi>06944904025353</udiDi>
    <basicUdiDi>694490400044C4*********4G</basicUdiDi>
    <tradeName>Complement C4 Kit (Turbidimetry Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010205</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-000879-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:11:01.740Z</lastUpdated>
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    <udiDi>06944904026343</udiDi>
    <basicUdiDi>694490400044C3*********3K</basicUdiDi>
    <tradeName>Complement C3 Kit (Turbidimetry Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010203</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C3/C3C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-001614-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:11:01.141Z</lastUpdated>
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    <udiDi>06944904050829</udiDi>
    <basicUdiDi>694490400044C4*********4G</basicUdiDi>
    <tradeName>Complement C4 Kit (Turbidimetry Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0102010205</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004604-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:28.819Z</lastUpdated>
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    <udiDi>06944904053486</udiDi>
    <basicUdiDi>694490400044C3*********3K</basicUdiDi>
    <tradeName>Complement C3 Kit (Turbidimetry Method)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <emdnCode>W0102010203</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C3/C3C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-004617-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:27.320Z</lastUpdated>
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    <udiDi>00816426020085</udiDi>
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    <tradeName>K-ASSAY Complement C4</tradeName>
    <deviceName>Complement C4 Reagent</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
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    <emdnCode>W0102010205</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-010</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:36:26.677Z</lastUpdated>
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    <tradeName>K-ASSAY Complement C3</tradeName>
    <deviceName>Complement C3 Reagent</deviceName>
    <manufacturerName>KAMIYA BIOMEDICAL COMPANY, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002769</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102010203</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C3/C3C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KAI-009</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-04T18:36:25.875Z</lastUpdated>
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    <manufacturerName>Instrumentation Laboratory SpA</manufacturerName>
    <manufacturerSrn>IT-MF-000009277</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010205</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0018169740</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:24:42.826Z</lastUpdated>
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    <manufacturerName>Instrumentation Laboratory SpA</manufacturerName>
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    <emdnCode>W0102010203</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C3/C3C</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0018169640</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:24:42.068Z</lastUpdated>
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    <manufacturerName>Medicon Hellas SA</manufacturerName>
    <manufacturerSrn>GR-MF-000013625</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102010205</emdnCode>
    <emdnDescription>COMPLEMENT COMPONENT C4</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1418-0750</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:53:02.775Z</lastUpdated>
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