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    <deviceName>DAT-QC IgG</deviceName>
    <manufacturerName>Institut de Biotechnologies Jacques Boy</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>COOMBS CONTROL CELLS</emdnDescription>
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    <udiDi>03760369291187</udiDi>
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    <tradeName>03760369291187</tradeName>
    <deviceName>RedQal Group</deviceName>
    <manufacturerName>ETABLISSEMENT FRANCAIS DU SANG</manufacturerName>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>COMBINED ABO TYPING + RHESUS TYPING TEST - OTHER</emdnDescription>
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    <tradeName>CQI ABO-D - Rh.K - Contrôle Qualité Interne pour la détermination des groupes   sanguins dans les systèmes ABO Rhésus Kell (CB Grifols)</tradeName>
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    <manufacturerName>ETABLISSEMENT FRANCAIS DU SANG</manufacturerName>
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    <emdnDescription>COMBINED ABO TYPING + RHESUS TYPING TEST - OTHER</emdnDescription>
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    <udiDi>D-01.244-02CZ</udiDi>
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    <tradeName>Anti-Jsb for card method monocolonal, IgG</tradeName>
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    <manufacturerName>ANTITOXIN GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008156</manufacturerSrn>
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    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
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    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.244-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:08:22.632Z</lastUpdated>
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    <udiDi>D-01.243-03CU</udiDi>
    <basicUdiDi>B-01.243-03CU</basicUdiDi>
    <tradeName>Anti-P1 for card method monoclonal, human IgM clone: P3NIL100</tradeName>
    <deviceName>Anti-P1 for card method monoclonal, human IgM clone: P3NIL100</deviceName>
    <manufacturerName>ANTITOXIN GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008156</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.243-03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:08:20.228Z</lastUpdated>
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    <udiDi>D-01.242-03CM</udiDi>
    <basicUdiDi>B-01.242-03CM</basicUdiDi>
    <tradeName>Anti-Leb for card method monoclonal, human clone: P3F234MD4</tradeName>
    <deviceName>Anti-Leb for card method monoclonal, human clone: P3F234MD4</deviceName>
    <manufacturerName>ANTITOXIN GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008156</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030501</emdnCode>
    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01.242-03</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:08:18.635Z</lastUpdated>
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    <udiDi>09354330001819</udiDi>
    <basicUdiDi>93543300030010L6</basicUdiDi>
    <tradeName>DAY Neutral Gel</tradeName>
    <deviceName>DAY Neutral Gel</deviceName>
    <manufacturerName>Haemokinesis Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033867</manufacturerSrn>
    <authorisedRepresentativeName>Compliance Management Solutions Europe LTD</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BG-AR-000020809</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030399</emdnCode>
    <emdnDescription>IMMUNOHAEMATOLOGY  (BLOOD GROUPING) TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30011-4</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:07:41.590Z</lastUpdated>
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    <tradeName>DAY LISS Diluent</tradeName>
    <deviceName>DAY LISS Diluent</deviceName>
    <manufacturerName>Haemokinesis Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033867</manufacturerSrn>
    <authorisedRepresentativeName>Compliance Management Solutions Europe LTD</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BG-AR-000020809</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>31010-4</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:07:37.589Z</lastUpdated>
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    <udiDi>09354330001345</udiDi>
    <basicUdiDi>93543300320106MG</basicUdiDi>
    <tradeName>DAY Bromelin Reagent</tradeName>
    <deviceName>DAY Bromelin Reagent</deviceName>
    <manufacturerName>Haemokinesis Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033867</manufacturerSrn>
    <authorisedRepresentativeName>Compliance Management Solutions Europe LTD</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BG-AR-000020809</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>32010-6</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:07:35.244Z</lastUpdated>
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    <udiDi>09354330000553</udiDi>
    <basicUdiDi>93543300GT20118P</basicUdiDi>
    <tradeName>STARGEL10 STAR SOLUTION</tradeName>
    <deviceName>STARGEL10 STAR SOLUTION</deviceName>
    <manufacturerName>Haemokinesis Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033867</manufacturerSrn>
    <authorisedRepresentativeName>Compliance Management Solutions Europe LTD</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BG-AR-000020809</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>GT2011</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:07:29.592Z</lastUpdated>
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    <udiDi>09354330000263</udiDi>
    <basicUdiDi>93543300GT20108M</basicUdiDi>
    <tradeName>STARGEL10 NEUTRAL</tradeName>
    <deviceName>STARGEL10 NEUTRAL</deviceName>
    <manufacturerName>Haemokinesis Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033867</manufacturerSrn>
    <authorisedRepresentativeName>Compliance Management Solutions Europe LTD</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BG-AR-000020809</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01030399</emdnCode>
    <emdnDescription>IMMUNOHAEMATOLOGY  (BLOOD GROUPING) TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GT2010-10</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:07:28.783Z</lastUpdated>
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    <udiDi>09354330000058</udiDi>
    <basicUdiDi>93543300TT1003DS</basicUdiDi>
    <tradeName>STATUS1 Solution</tradeName>
    <deviceName>STATUS1 Solution</deviceName>
    <manufacturerName>Haemokinesis Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000033867</manufacturerSrn>
    <authorisedRepresentativeName>Compliance Management Solutions Europe LTD</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TT1003</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T21:07:24.806Z</lastUpdated>
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    <tradeName>immuClone® Anti-A,B IgM</tradeName>
    <deviceName>immuClone® Anti-A,B IgM</deviceName>
    <manufacturerName>IMMUCOR Medizinische Diagnostik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006494</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf D</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103030102</emdnCode>
    <emdnDescription>ABO SERA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0066003</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:09:44.297Z</lastUpdated>
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    <tradeName>immuClone® Anti-B IgM</tradeName>
    <deviceName>immuClone® Anti-B IgM</deviceName>
    <manufacturerName>IMMUCOR Medizinische Diagnostik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006494</manufacturerSrn>
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    <emdnDescription>ABO SERA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:09:41.833Z</lastUpdated>
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    <tradeName>immuClone® Anti-A IgM</tradeName>
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    <manufacturerName>IMMUCOR Medizinische Diagnostik GmbH</manufacturerName>
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    <manufacturerName>IMMUCOR Medizinische Diagnostik GmbH</manufacturerName>
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    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0008016</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:09:39.446Z</lastUpdated>
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    <tradeName>Anti-K (Kell) quick</tradeName>
    <deviceName>Anti-K (Kell) quick</deviceName>
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    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
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    <emdnDescription>OTHER ANTIGEN TYPING REAGENTS</emdnDescription>
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