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    <udiDi>05904365620321</udiDi>
    <basicUdiDi>5904365620MEH4</basicUdiDi>
    <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>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>918</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:33:30.722Z</lastUpdated>
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  <row>
    <udiDi>05904365620314</udiDi>
    <basicUdiDi>5904365620ELGS</basicUdiDi>
    <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>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>919</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T10:33:29.923Z</lastUpdated>
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  <row>
    <udiDi>05060242472602</udiDi>
    <basicUdiDi>0506024247FD313BAQ</basicUdiDi>
    <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>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6324445</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:48:08.439Z</lastUpdated>
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  <row>
    <udiDi>D-R145142J</udiDi>
    <basicUdiDi>B-R145142J</basicUdiDi>
    <tradeName>D-R145142J</tradeName>
    <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>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030399</emdnCode>
    <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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  <row>
    <udiDi>D-R145132G</udiDi>
    <basicUdiDi>B-R145132G</basicUdiDi>
    <tradeName>D-R145132G</tradeName>
    <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>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R14513</reference>
    <placedOnMarketCountry>Iceland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:02:02.685Z</lastUpdated>
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  <row>
    <udiDi>D-R145122E</udiDi>
    <basicUdiDi>B-R145122E</basicUdiDi>
    <tradeName>D-R145122E</tradeName>
    <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>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R14512</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:02:01.986Z</lastUpdated>
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  <row>
    <udiDi>D-R145112C</udiDi>
    <basicUdiDi>B-R145112C</basicUdiDi>
    <tradeName>D-R145112C</tradeName>
    <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>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R14511</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-22T12:01:56.272Z</lastUpdated>
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  <row>
    <udiDi>08682484709772</udiDi>
    <basicUdiDi>B-08682484709772</basicUdiDi>
    <tradeName>A1 Gel</tradeName>
    <deviceName>A1 Gel</deviceName>
    <manufacturerName>RED CELL BİYOTEKNOLOJİ A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000026921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RCA1</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-16T20:10:45.112Z</lastUpdated>
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  <row>
    <udiDi>08682484709789</udiDi>
    <basicUdiDi>B-08682484709789</basicUdiDi>
    <tradeName>H Gel</tradeName>
    <deviceName>H Gel</deviceName>
    <manufacturerName>RED CELL BİYOTEKNOLOJİ A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000026921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RCH</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:12:41.168Z</lastUpdated>
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  <row>
    <udiDi>08682484709765</udiDi>
    <basicUdiDi>B-08682484709765</basicUdiDi>
    <tradeName>IgG</tradeName>
    <deviceName>IgG</deviceName>
    <manufacturerName>RED CELL BİYOTEKNOLOJİ A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000026921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RCIGG</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:12:39.558Z</lastUpdated>
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  <row>
    <udiDi>08682484709758</udiDi>
    <basicUdiDi>B-08682484709758</basicUdiDi>
    <tradeName>DAT Duo</tradeName>
    <deviceName>DAT Duo</deviceName>
    <manufacturerName>RED CELL BİYOTEKNOLOJİ A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000026921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RCDATDUO</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:12:35.540Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682484709741</udiDi>
    <basicUdiDi>B-08682484709741</basicUdiDi>
    <tradeName>DAT Screen</tradeName>
    <deviceName>DAT Screen</deviceName>
    <manufacturerName>RED CELL BİYOTEKNOLOJİ A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000026921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RCDAT</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:12:34.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682484709734</udiDi>
    <basicUdiDi>B-08682484709734</basicUdiDi>
    <tradeName>Neutral Gel</tradeName>
    <deviceName>Neutral Gel</deviceName>
    <manufacturerName>RED CELL BİYOTEKNOLOJİ A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000026921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RCNEU</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:12:33.937Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682484709727</udiDi>
    <basicUdiDi>B-08682484709727</basicUdiDi>
    <tradeName>Neutral / AHG</tradeName>
    <deviceName>Neutral / AHG</deviceName>
    <manufacturerName>RED CELL BİYOTEKNOLOJİ A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000026921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RCNAHG</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:12:33.136Z</lastUpdated>
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  <row>
    <udiDi>08682484709710</udiDi>
    <basicUdiDi>B-08682484709710</basicUdiDi>
    <tradeName>AHG</tradeName>
    <deviceName>AHG</deviceName>
    <manufacturerName>RED CELL BİYOTEKNOLOJİ A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000026921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RCAHG</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:12:29.142Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682484709130</udiDi>
    <basicUdiDi>B-08682484709130</basicUdiDi>
    <tradeName>Neutral / AHG</tradeName>
    <deviceName>Neutral / AHG</deviceName>
    <manufacturerName>RED CELL BİYOTEKNOLOJİ A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000026921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RCNAHG</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:11:48.244Z</lastUpdated>
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  <row>
    <udiDi>08682484709123</udiDi>
    <basicUdiDi>B-08682484709123</basicUdiDi>
    <tradeName>IgG</tradeName>
    <deviceName>IgG</deviceName>
    <manufacturerName>RED CELL BİYOTEKNOLOJİ A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000026921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RCIGG</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:11:44.252Z</lastUpdated>
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  <row>
    <udiDi>08682484709109</udiDi>
    <basicUdiDi>B-08682484709109</basicUdiDi>
    <tradeName>AHG</tradeName>
    <deviceName>AHG</deviceName>
    <manufacturerName>RED CELL BİYOTEKNOLOJİ A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000026921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RCAHG</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:11:42.651Z</lastUpdated>
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  <row>
    <udiDi>08682484709093</udiDi>
    <basicUdiDi>B-08682484709093</basicUdiDi>
    <tradeName>DAT Duo</tradeName>
    <deviceName>DAT Duo</deviceName>
    <manufacturerName>RED CELL BİYOTEKNOLOJİ A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000026921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RCDATDUO</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:11:41.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>08682484709086</udiDi>
    <basicUdiDi>B-08682484709086</basicUdiDi>
    <tradeName>DAT Screen</tradeName>
    <deviceName>DAT Screen</deviceName>
    <manufacturerName>RED CELL BİYOTEKNOLOJİ A.Ş.</manufacturerName>
    <manufacturerSrn>TR-MF-000026921</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030399</emdnCode>
    <emdnDescription>ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RCDAT</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T18:11:37.841Z</lastUpdated>
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