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    <tradeName>Blood Gas and Chemistry Analyzer</tradeName>
    <deviceName>Blood Gas and Chemistry Analyzer</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040101</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>i500</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:30:22.461Z</lastUpdated>
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    <udiDi>06944413814424</udiDi>
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    <tradeName>Blood Gas and Chemistry Analyzer</tradeName>
    <deviceName>Blood Gas and Chemistry Analyzer</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201040102</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSERS - WITH ADDITIONAL PARAMETERS (pH, pO2, pCO2, Hct + metabolites + electrolytes, CO-oximeter parameters and coagulation parameters)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>i2005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:14:35.422Z</lastUpdated>
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    <tradeName>Blood Gas and Chemistry Analyzer</tradeName>
    <deviceName>Blood Gas and Chemistry Analyzer</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0201040102</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSERS - WITH ADDITIONAL PARAMETERS (pH, pO2, pCO2, Hct + metabolites + electrolytes, CO-oximeter parameters and coagulation parameters)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>i20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T09:14:26.166Z</lastUpdated>
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    <basicUdiDi>69444138i15SVA</basicUdiDi>
    <tradeName>Blood Gas and Chemistry Analyzer</tradeName>
    <deviceName>Blood Gas and Chemistry Analyzer</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040101</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>i15A</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:48:21.071Z</lastUpdated>
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    <udiDi>06944413801875</udiDi>
    <basicUdiDi>69444138i15SVA</basicUdiDi>
    <tradeName>Blood Gas and Chemistry Analyzer</tradeName>
    <deviceName>Blood Gas and Chemistry Analyzer</deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040101</emdnCode>
    <emdnDescription>BLOOD GAS ANALYSERS - WITH CLASSIC PROFILE (pH, pO2, pCO2, HCT + electrolytes)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>i15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-27T08:46:59.974Z</lastUpdated>
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    <udiDi>06936895300267</udiDi>
    <basicUdiDi>6936895BS0062C</basicUdiDi>
    <tradeName>Electrolyte Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201040201</emdnCode>
    <emdnDescription>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:06.023Z</lastUpdated>
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    <udiDi>06936895300274</udiDi>
    <basicUdiDi>6936895BS0062C</basicUdiDi>
    <tradeName>Electrolyte Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201040201</emdnCode>
    <emdnDescription>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:06.012Z</lastUpdated>
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    <udiDi>06936895300281</udiDi>
    <basicUdiDi>6936895BS0062C</basicUdiDi>
    <tradeName>Electrolyte Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biobase Biodustry(Shandong) Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000025015</manufacturerSrn>
    <authorisedRepresentativeName>Luxus Lebenswelt GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005110</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201040201</emdnCode>
    <emdnDescription>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BS006</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-26T11:18:05.999Z</lastUpdated>
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    <basicUdiDi>0379497ELNAKClCaQL</basicUdiDi>
    <tradeName>EasyLyte Neo 600mL Solution Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medica Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000037250</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040201</emdnCode>
    <emdnDescription>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30201</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:13:39.294Z</lastUpdated>
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    <udiDi>00379497006339</udiDi>
    <basicUdiDi>0379497ELNAKClCaQL</basicUdiDi>
    <tradeName>EasyLyte Neo 1200ml Solution Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medica Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000037250</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040201</emdnCode>
    <emdnDescription>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30202</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:13:39.270Z</lastUpdated>
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    <udiDi>00379497006391</udiDi>
    <basicUdiDi>0379497ELNAKClCaQL</basicUdiDi>
    <tradeName>EasyLyte Neo Sodium Electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medica Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000037250</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040201</emdnCode>
    <emdnDescription>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:13:39.237Z</lastUpdated>
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    <udiDi>00379497006407</udiDi>
    <basicUdiDi>0379497ELNAKClCaQL</basicUdiDi>
    <tradeName>EasyLyte Neo Potassium Electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medica Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000037250</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040201</emdnCode>
    <emdnDescription>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30101</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:13:39.213Z</lastUpdated>
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    <basicUdiDi>0379497ELNAKClCaQL</basicUdiDi>
    <tradeName>EasyLyte Neo Cl Electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medica Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000037250</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040201</emdnCode>
    <emdnDescription>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30103</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:13:39.191Z</lastUpdated>
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    <basicUdiDi>0379497ELNAKClCaQL</basicUdiDi>
    <tradeName>EasyLyte Neo Ca Electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medica Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000037250</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf B</riskClass>
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    <emdnDescription>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30150</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:13:39.168Z</lastUpdated>
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    <basicUdiDi>0379497ELNAKClCaQL</basicUdiDi>
    <tradeName>Reference Electrode</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medica Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000037250</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040201</emdnCode>
    <emdnDescription>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T15:13:39.138Z</lastUpdated>
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    <tradeName>Electrolyte Analyzer Model:EX-Ds</tradeName>
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    <manufacturerName>JOKOH CO.,LTD.</manufacturerName>
    <manufacturerSrn>JP-MF-000025161</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201040201</emdnCode>
    <emdnDescription>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>J11018</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-22T12:16:24.750Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040201</emdnCode>
    <emdnDescription>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CBS-301</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:36:01.151Z</lastUpdated>
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    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040201</emdnCode>
    <emdnDescription>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CBS-30</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:36:01.141Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040201</emdnCode>
    <emdnDescription>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CBS-400</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:36:01.131Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>B&amp;E BIO-TECHNOLOGY CO., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000023256</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201040201</emdnCode>
    <emdnDescription>ION SELECTIVE ELECTROLYTE ANALYSERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CBS-401</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T10:36:01.121Z</lastUpdated>
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