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    <deviceName>Mi(a)-Cyte 0.8%</deviceName>
    <manufacturerName>Medion Grifols Diagnostics AG</manufacturerName>
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    <authorisedRepresentativeName>Diagnostic Grifols, S.A.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>ANTIBODY IDENTIFICATION CELL PANELS</emdnDescription>
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    <basicUdiDi>764013734DataExtend0.8WB</basicUdiDi>
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    <tradeName>Diego(a)-Cyte 3%</tradeName>
    <deviceName>Diego(a)-Cyte 3%</deviceName>
    <manufacturerName>Medion Grifols Diagnostics AG</manufacturerName>
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    <basicUdiDi>764013734Diego0.8SK</basicUdiDi>
    <tradeName>Diego(a)-Cyte 0.8%</tradeName>
    <deviceName>Diego(a)-Cyte 0.8%</deviceName>
    <manufacturerName>Medion Grifols Diagnostics AG</manufacturerName>
    <manufacturerSrn>CH-MF-000024272</manufacturerSrn>
    <authorisedRepresentativeName>Diagnostic Grifols, S.A.</authorisedRepresentativeName>
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    <emdnDescription>ANTIBODY IDENTIFICATION CELL PANELS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>07640137341053</udiDi>
    <basicUdiDi>764013734Antis-C-125M6</basicUdiDi>
    <tradeName>Anti-C3d</tradeName>
    <deviceName>Anti-C3d</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 C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030305</emdnCode>
    <emdnDescription>MONOSPECIFIC ANTIHUMAN SERUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>213566</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:03:19.357Z</lastUpdated>
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    <udiDi>06925661508013</udiDi>
    <basicUdiDi>69256615XSY01Z9</basicUdiDi>
    <tradeName>BT Liss</tradeName>
    <deviceName>BT Liss</deviceName>
    <manufacturerName>Shanghai Runpu Biotechnology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027207</manufacturerSrn>
    <authorisedRepresentativeName>R Sight B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000010445</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>
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    <tradeName>PBS zbuforowany fizjolicziczny roztwór soli do badań serogicznych pH 6,9 (2litry)</tradeName>
    <deviceName>PBS – buffered salt solution pH 6,9</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)</emdnDescription>
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    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:38:17.489Z</lastUpdated>
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    <tradeName>2-ME Roztwór do różnicowania przeciwciał klasy IgM i IgG</tradeName>
    <deviceName>2-ME solution for the differrentiation of IgM and IgG antibodies</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:33:30.722Z</lastUpdated>
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    <tradeName>Odczynniki do elucji. Kwaśna glicyna/ 10% EDTA/ 1M TRIS</tradeName>
    <deviceName>Reagents for elution The acid glycine, 10% EDTA, 1M TRIS</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:33:29.923Z</lastUpdated>
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    <basicUdiDi>5904365620PBSBL</basicUdiDi>
    <tradeName>PBS zbuforowany fizjologiczny roztwór soli do badań serologicznych pH 6,9</tradeName>
    <deviceName>PBS – buffered salt solution pH 6,9</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030306</emdnCode>
    <emdnDescription>ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>111</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:33:29.128Z</lastUpdated>
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    <udiDi>05904365620277</udiDi>
    <basicUdiDi>5904365620LISSM99</basicUdiDi>
    <tradeName>LISS-M (low ionic strenght solution medium) jest roztworem soli o niskiej sile jonowej,  wystandaryzowanych  wartościach  pH   i  osmolalności, stosowany jest do przemywania i sporządzania zawiesin krwinek czerwonych</tradeName>
    <deviceName>LISS - M Modified low ionic strenght salt solution</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <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>911</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:33:25.145Z</lastUpdated>
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    <tradeName>LISS-L standaryzowany roztwór soli o niskiej sile jonowej do badań serologicznych</tradeName>
    <deviceName>LISS - L Low ionic strenght salt solution</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:33:24.327Z</lastUpdated>
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    <basicUdiDi>5904365620PEGB5</basicUdiDi>
    <tradeName>PEG roztwór glikolu polietylenowego do pośredniego testu antyglobulinowego</tradeName>
    <deviceName>PEG - Polyethylene glycol solution for indirect antiglobulin test</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:33:23.550Z</lastUpdated>
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    <basicUdiDi>5904365620KOLBL</basicUdiDi>
    <tradeName>Surowica Grupy AB</tradeName>
    <deviceName>AB Group Serum</deviceName>
    <manufacturerName>Regionalne Centrum Krwiodawstwa i Krwiolecznictwa w Katowicach</manufacturerName>
    <manufacturerSrn>PL-MF-000037642</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-31T10:33:22.967Z</lastUpdated>
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    <tradeName>MLB 2</tradeName>
    <deviceName>MLB 2</deviceName>
    <manufacturerName>Bio-Rad Medical Diagnostics GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000019864</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:18:25.496Z</lastUpdated>
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    <tradeName>ORTHOTM Elution Kit</tradeName>
    <deviceName>ORTHOTM Elution Kit</deviceName>
    <manufacturerName>Alba Bioscience Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000029300</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6324445</reference>
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    <lastUpdated>2026-07-30T15:48:08.439Z</lastUpdated>
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    <tradeName>22% SEROLOGICAL ALBUMIN</tradeName>
    <deviceName>22% Serological albumin</deviceName>
    <manufacturerName>Spinreact S.A.U.</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-29T22:38:34.740Z</lastUpdated>
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    <manufacturerName>Spinreact S.A.U.</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W0103030306</emdnCode>
    <emdnDescription>ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-29T22:38:32.343Z</lastUpdated>
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    <tradeName>AHG serum blend</tradeName>
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    <manufacturerName>ANTITOXIN GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>POLYSPECIFIC ANTIHUMAN SERUM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>03.140-10</reference>
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    <lastUpdated>2026-07-22T20:48:47.437Z</lastUpdated>
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    <deviceName>Serum Amyloid A Protein (SAA) Reagent Kit (Chemiluminescent Immunoassay)</deviceName>
    <manufacturerName>Rayto Life and Analytical Sciences Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000011141</manufacturerSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R14514</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:02:03.476Z</lastUpdated>
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