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    <basicUdiDi>B-Z257K5</basicUdiDi>
    <tradeName>ALBAcheck® - BGS High Titre Control Kit</tradeName>
    <deviceName>ALBAcheck® - BGS High Titre Controls 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 Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030499</emdnCode>
    <emdnDescription>IMMUNOHAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Z257</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T11:12:33.743Z</lastUpdated>
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    <udiDi>06978168790122</udiDi>
    <basicUdiDi>B-06978168790122</basicUdiDi>
    <tradeName>06978168790122</tradeName>
    <deviceName>LH Gold Rapid Screen Test</deviceName>
    <manufacturerName>TIANJIN MINGAO BIOTECHNOLOGY CO.，LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045817</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030402</emdnCode>
    <emdnDescription>CONTROL KITS  (IMMUNOHAEMATOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Cassette</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:41:58.892Z</lastUpdated>
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    <udiDi>06978168790108</udiDi>
    <basicUdiDi>B-06978168790108</basicUdiDi>
    <tradeName>06978168790108</tradeName>
    <deviceName>HCG Gold Rapid Screen Test</deviceName>
    <manufacturerName>TIANJIN MINGAO BIOTECHNOLOGY CO.，LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045817</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030402</emdnCode>
    <emdnDescription>CONTROL KITS  (IMMUNOHAEMATOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Strip</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:41:57.524Z</lastUpdated>
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    <udiDi>06978168790092</udiDi>
    <basicUdiDi>B-06978168790092</basicUdiDi>
    <tradeName>06978168790092</tradeName>
    <deviceName>HCG Gold Rapid Screen Test</deviceName>
    <manufacturerName>TIANJIN MINGAO BIOTECHNOLOGY CO.，LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045817</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030402</emdnCode>
    <emdnDescription>CONTROL KITS  (IMMUNOHAEMATOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Cassette</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:41:56.629Z</lastUpdated>
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    <udiDi>06978168790115</udiDi>
    <basicUdiDi>B-06978168790115</basicUdiDi>
    <tradeName>06978168790115</tradeName>
    <deviceName>LH Gold Rapid Screen Test</deviceName>
    <manufacturerName>TIANJIN MINGAO BIOTECHNOLOGY CO.，LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045817</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030402</emdnCode>
    <emdnDescription>CONTROL KITS  (IMMUNOHAEMATOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Strip</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:41:55.288Z</lastUpdated>
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    <udiDi>06978168790085</udiDi>
    <basicUdiDi>B-06978168790085</basicUdiDi>
    <tradeName>06978168790085</tradeName>
    <deviceName>HCG Gold Rapid Screen Test</deviceName>
    <manufacturerName>TIANJIN MINGAO BIOTECHNOLOGY CO.，LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045817</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030402</emdnCode>
    <emdnDescription>CONTROL KITS  (IMMUNOHAEMATOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Midstream</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:41:52.484Z</lastUpdated>
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    <udiDi>06978168790078</udiDi>
    <basicUdiDi>B-06978168790078</basicUdiDi>
    <tradeName>06978168790078</tradeName>
    <deviceName>Dengue IgG/IgM Gold Rapid Screen Test</deviceName>
    <manufacturerName>TIANJIN MINGAO BIOTECHNOLOGY CO.，LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045817</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030402</emdnCode>
    <emdnDescription>CONTROL KITS  (IMMUNOHAEMATOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Strip</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:41:37.209Z</lastUpdated>
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    <udiDi>06978168790061</udiDi>
    <basicUdiDi>B-06978168790061</basicUdiDi>
    <tradeName>06978168790061</tradeName>
    <deviceName>Dengue IgG/IgM Gold Rapid Screen Test</deviceName>
    <manufacturerName>TIANJIN MINGAO BIOTECHNOLOGY CO.，LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045817</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030402</emdnCode>
    <emdnDescription>CONTROL KITS  (IMMUNOHAEMATOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Cassette</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:41:36.404Z</lastUpdated>
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    <udiDi>06978168790054</udiDi>
    <basicUdiDi>B-06978168790054</basicUdiDi>
    <tradeName>06978168790054</tradeName>
    <deviceName>Dengue IgG/IgM Gold Rapid Screen Test</deviceName>
    <manufacturerName>TIANJIN MINGAO BIOTECHNOLOGY CO.，LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045817</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030402</emdnCode>
    <emdnDescription>CONTROL KITS  (IMMUNOHAEMATOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Midstream</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:41:35.610Z</lastUpdated>
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  <row>
    <udiDi>06978168790047</udiDi>
    <basicUdiDi>B-06978168790047</basicUdiDi>
    <tradeName>06978168790047</tradeName>
    <deviceName>Malaria Pf/Pv Gold Rapid Screen Test</deviceName>
    <manufacturerName>TIANJIN MINGAO BIOTECHNOLOGY CO.，LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045817</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030402</emdnCode>
    <emdnDescription>CONTROL KITS  (IMMUNOHAEMATOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Cassette</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:41:34.814Z</lastUpdated>
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    <udiDi>06978168790030</udiDi>
    <basicUdiDi>B-06978168790030</basicUdiDi>
    <tradeName>06978168790030</tradeName>
    <deviceName>TP Gold Rapid Screen Test</deviceName>
    <manufacturerName>TIANJIN MINGAO BIOTECHNOLOGY CO.，LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045817</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030402</emdnCode>
    <emdnDescription>CONTROL KITS  (IMMUNOHAEMATOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Cassette</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:41:30.807Z</lastUpdated>
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    <udiDi>06978168790023</udiDi>
    <basicUdiDi>B-06978168790023</basicUdiDi>
    <tradeName>06978168790023</tradeName>
    <deviceName>TP Gold Rapid Screen Test</deviceName>
    <manufacturerName>TIANJIN MINGAO BIOTECHNOLOGY CO.，LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045817</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030402</emdnCode>
    <emdnDescription>CONTROL KITS  (IMMUNOHAEMATOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Strip</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:41:30.001Z</lastUpdated>
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    <udiDi>06978168790016</udiDi>
    <basicUdiDi>B-06978168790016</basicUdiDi>
    <tradeName>06978168790016</tradeName>
    <deviceName>COVID-19 Antigen Rapid Detection Kit（Colloidal gold)</deviceName>
    <manufacturerName>TIANJIN MINGAO BIOTECHNOLOGY CO.，LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045817</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030402</emdnCode>
    <emdnDescription>CONTROL KITS  (IMMUNOHAEMATOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Cassette</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:41:29.206Z</lastUpdated>
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    <udiDi>06978168790009</udiDi>
    <basicUdiDi>B-06978168790009</basicUdiDi>
    <tradeName>06978168790009</tradeName>
    <deviceName>COVID-19 Neutralizing Antibody Rapid Detection Kit（Colloidal gold）</deviceName>
    <manufacturerName>TIANJIN MINGAO BIOTECHNOLOGY CO.，LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000045817</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030402</emdnCode>
    <emdnDescription>CONTROL KITS  (IMMUNOHAEMATOLOGY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Cassette</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:41:28.406Z</lastUpdated>
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    <udiDi>03770008181465</udiDi>
    <basicUdiDi>B-03770008181465</basicUdiDi>
    <tradeName>03770008181465</tradeName>
    <deviceName>DAT-QC C3b-C3d</deviceName>
    <manufacturerName>Institut de Biotechnologies Jacques Boy</manufacturerName>
    <manufacturerSrn>FR-MF-000004609</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030401</emdnCode>
    <emdnDescription>COOMBS CONTROL CELLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>97367</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:21:15.163Z</lastUpdated>
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    <udiDi>03770008181458</udiDi>
    <basicUdiDi>B-03770008181458</basicUdiDi>
    <tradeName>03770008181458</tradeName>
    <deviceName>DAT-QC IgG</deviceName>
    <manufacturerName>Institut de Biotechnologies Jacques Boy</manufacturerName>
    <manufacturerSrn>FR-MF-000004609</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103030401</emdnCode>
    <emdnDescription>COOMBS CONTROL CELLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>97257</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T19:21:13.547Z</lastUpdated>
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    <udiDi>10888234300199</udiDi>
    <basicUdiDi>88823405W0103030499D48QB</basicUdiDi>
    <tradeName>immuClone® Rh-Hr Control IgM</tradeName>
    <deviceName>immuClone® Rh-Hr Control IgM and Galileo</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>W0103030499</emdnCode>
    <emdnDescription>IMMUNOHAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0006720</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:09:16.217Z</lastUpdated>
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    <udiDi>10888234001102</udiDi>
    <basicUdiDi>88823401W0103030401C100RY</basicUdiDi>
    <tradeName>DAT Positive Control Cell (1 x 10 mL)</tradeName>
    <deviceName>DAT Positive Control Cell</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>0066122</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:08:46.525Z</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>10888234300205</udiDi>
    <basicUdiDi>88823405W0103030499D48QB</basicUdiDi>
    <tradeName>immuClone® Rh-Hr Control IgM</tradeName>
    <deviceName></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>W0103030499</emdnCode>
    <emdnDescription>IMMUNOHAEMATOLOGY CONTROLS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0006721</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T13:13:45.061Z</lastUpdated>
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