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    <deviceName>W.A.R.M.(Warm Autoantibody Removal Medium)</deviceName>
    <manufacturerName>Immucor, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011568</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030307</emdnCode>
    <emdnDescription>ENZYMES (E.G. BROMELIN / PAPAIN, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W.A.R.M. (Warm Autoantibody Removal Medium)</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:08:40.118Z</lastUpdated>
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    <udiDi>10888234001003</udiDi>
    <basicUdiDi>88823401W01030399C040005T</basicUdiDi>
    <tradeName>RESt (Rabbit Erythrocyte Stroma)</tradeName>
    <deviceName>RESt (Rabbit Erythrocyte Stroma)</deviceName>
    <manufacturerName>Immucor, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011568</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0057316</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:08:37.717Z</lastUpdated>
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    <udiDi>10888234000990</udiDi>
    <basicUdiDi>88823401W0103030307C002TG</basicUdiDi>
    <tradeName>Freeze-Dried Papain</tradeName>
    <deviceName>Freeze-Dried Papain</deviceName>
    <manufacturerName>Immucor, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011568</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030307</emdnCode>
    <emdnDescription>ENZYMES (E.G. BROMELIN / PAPAIN, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0057292</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:08:36.140Z</lastUpdated>
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    <udiDi>10888234000914</udiDi>
    <basicUdiDi>88823401W0103030401C200S5</basicUdiDi>
    <tradeName>Complement Control Cells</tradeName>
    <deviceName>Complement Control Cells</deviceName>
    <manufacturerName>Immucor, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011568</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030401</emdnCode>
    <emdnDescription>COOMBS CONTROL CELLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0007930</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:08:35.319Z</lastUpdated>
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    <udiDi>10888234000877</udiDi>
    <basicUdiDi>88823401W01030399C020025H</basicUdiDi>
    <tradeName>Gamma EGA Kit</tradeName>
    <deviceName>Gamma EGA Kit</deviceName>
    <manufacturerName>Immucor, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011568</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030299</emdnCode>
    <emdnDescription>RHESUS TYPING ASSAYS OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0007865</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:08:33.729Z</lastUpdated>
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    <udiDi>10888234000860</udiDi>
    <basicUdiDi>88823401W01030399C020015F</basicUdiDi>
    <tradeName>Gamma ELU-KIT II</tradeName>
    <deviceName>Gamma ELU-KIT II</deviceName>
    <manufacturerName>Immucor, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011568</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0007861</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:08:31.333Z</lastUpdated>
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    <udiDi>10888234000853</udiDi>
    <basicUdiDi>88823401W01030399C0500062</basicUdiDi>
    <tradeName>Gamma Lewis Blood Group Substance</tradeName>
    <deviceName>Gamma Lewis Blood Group Substance</deviceName>
    <manufacturerName>Immucor, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011568</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030399</emdnCode>
    <emdnDescription>IMMUNOHAEMATOLOGY  (BLOOD GROUPING) TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0007702</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:08:29.741Z</lastUpdated>
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    <udiDi>10888234000846</udiDi>
    <basicUdiDi>88823401W01030399C0500164</basicUdiDi>
    <tradeName>Gamma P1 Blood Group Substance</tradeName>
    <deviceName>Gamma P1 Blood Group Substance</deviceName>
    <manufacturerName>Immucor, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011568</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0007700</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:08:28.910Z</lastUpdated>
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    <udiDi>10888234000785</udiDi>
    <basicUdiDi>88823401W0103030501C201SQ</basicUdiDi>
    <tradeName>Anti-Kpb - Blood Grouping Reagent</tradeName>
    <deviceName>Anti-Kpb Blood Grouping Reagent</deviceName>
    <manufacturerName>Immucor, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011568</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0007550</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:08:27.312Z</lastUpdated>
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    <udiDi>10888234000778</udiDi>
    <basicUdiDi>88823401W0103030501C200SN</basicUdiDi>
    <tradeName>Anti-Kpa Blood Grouping Reagent</tradeName>
    <deviceName>Anti-Kpa</deviceName>
    <manufacturerName>Immucor, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011568</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0007540</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:08:24.910Z</lastUpdated>
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    <udiDi>10888234000716</udiDi>
    <basicUdiDi>88823401W0103030307C001TE</basicUdiDi>
    <tradeName>GammaZyme-B</tradeName>
    <deviceName>GammaZyme-B</deviceName>
    <manufacturerName>Immucor, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011568</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030307</emdnCode>
    <emdnDescription>ENZYMES (E.G. BROMELIN / PAPAIN, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0007058</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:08:23.312Z</lastUpdated>
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    <udiDi>10888234000709</udiDi>
    <basicUdiDi>88823401W0103030307C000TC</basicUdiDi>
    <tradeName>GammaZyme-F</tradeName>
    <deviceName>GammaZyme-F</deviceName>
    <manufacturerName>Immucor, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011568</manufacturerSrn>
    <authorisedRepresentativeName>IMMUCOR Medizinische Diagnostik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007083</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030307</emdnCode>
    <emdnDescription>ENZYMES (E.G. BROMELIN / PAPAIN, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0007056</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:08:22.507Z</lastUpdated>
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    <basicUdiDi>868465194BS4H</basicUdiDi>
    <tradeName>Bromelin Solution</tradeName>
    <deviceName>Bromelin Solution</deviceName>
    <manufacturerName>RED CELL BİYOTEKNOLOJİ A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000026921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030307</emdnCode>
    <emdnDescription>ENZYMES (E.G. BROMELIN / PAPAIN, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RCBS10</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:32:45.180Z</lastUpdated>
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    <udiDi>08682484709017</udiDi>
    <basicUdiDi>868465194LISSTG</basicUdiDi>
    <tradeName>LISS Diluent</tradeName>
    <deviceName>LISS Diluent</deviceName>
    <manufacturerName>RED CELL BİYOTEKNOLOJİ A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000026921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030306</emdnCode>
    <emdnDescription>ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RCLISS500</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T15:32:42.776Z</lastUpdated>
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    <udiDi>08437014205664</udiDi>
    <basicUdiDi>843658373PAPAINP7</basicUdiDi>
    <tradeName>DG Papain</tradeName>
    <deviceName>DG Papain</deviceName>
    <manufacturerName>Diagnostic Grifols, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000000784</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030307</emdnCode>
    <emdnDescription>ENZYMES (E.G. BROMELIN / PAPAIN, ETC.)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>210357</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:49:04.701Z</lastUpdated>
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    <basicUdiDi>7798100041443151HZ</basicUdiDi>
    <tradeName>Albúmina bovina 30%</tradeName>
    <deviceName>Albúmina bovina 30%</deviceName>
    <manufacturerName>Wiener Laboratorios SAIC</manufacturerName>
    <manufacturerSrn>AR-MF-000023605</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030306</emdnCode>
    <emdnDescription>ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>1443151</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:09:08.129Z</lastUpdated>
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    <tradeName>Grifols sCD38</tradeName>
    <deviceName>Grifols sCD38</deviceName>
    <manufacturerName>Medion Grifols Diagnostics AG</manufacturerName>
    <manufacturerSrn>CH-MF-000024272</manufacturerSrn>
    <authorisedRepresentativeName>Diagnostic Grifols, S.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001573</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030399</emdnCode>
    <emdnDescription>IMMUNOHAEMATOLOGY  (BLOOD GROUPING) TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>213686</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:25:37.434Z</lastUpdated>
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    <tradeName>Specific Albumin 30%</tradeName>
    <deviceName>Specific Albumin 30%</deviceName>
    <manufacturerName>Medion Grifols Diagnostics AG</manufacturerName>
    <manufacturerSrn>CH-MF-000024272</manufacturerSrn>
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    <emdnDescription>ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:25:22.092Z</lastUpdated>
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    <tradeName>Specific Albumin 22%</tradeName>
    <deviceName>Specific Albumin 22%</deviceName>
    <manufacturerName>Medion Grifols Diagnostics AG</manufacturerName>
    <manufacturerSrn>CH-MF-000024272</manufacturerSrn>
    <authorisedRepresentativeName>Diagnostic Grifols, S.A.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>213422</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:25:21.278Z</lastUpdated>
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    <deviceName>Enlisst-II</deviceName>
    <manufacturerName>Medion Grifols Diagnostics AG</manufacturerName>
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    <authorisedRepresentativeName>Diagnostic Grifols, S.A.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001573</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030306</emdnCode>
    <emdnDescription>ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>213577</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T03:25:20.501Z</lastUpdated>
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