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    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
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    <lastUpdated>2026-08-03T06:49:34.045Z</lastUpdated>
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    <tradeName>GLYCOHEMOGLOBIN A 1C REAGENT KIT</tradeName>
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    <tradeName>GLYCOHEMOGLOBIN A 1C REAGENT KIT</tradeName>
    <deviceName>GLYCOHEMOGLOBIN A 1C REAGENT KIT</deviceName>
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    <tradeName>GLYCOHEMOGLOBIN A 1C REAGENT KIT</tradeName>
    <deviceName>GLYCOHEMOGLOBIN A 1C REAGENT KIT</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000001891</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:49:28.439Z</lastUpdated>
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    <udiDi>06925794593283</udiDi>
    <basicUdiDi>B-06925794593283</basicUdiDi>
    <tradeName>GLYCOHEMOGLOBIN A 1C REAGENT KIT</tradeName>
    <deviceName>GLYCOHEMOGLOBIN A 1C REAGENT KIT</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
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    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3021571</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:49:27.637Z</lastUpdated>
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    <udiDi>06925794593276</udiDi>
    <basicUdiDi>B-06925794593276</basicUdiDi>
    <tradeName>GLYCOHEMOGLOBIN A 1C REAGENT KIT</tradeName>
    <deviceName>GLYCOHEMOGLOBIN A 1C REAGENT KIT</deviceName>
    <manufacturerName>DIRUI INDUSTRIAL CO., LTD</manufacturerName>
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    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-08-03T06:49:26.835Z</lastUpdated>
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    <udiDi>05907514694570</udiDi>
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    <tradeName>OS-HbA1C DIRECT</tradeName>
    <deviceName>HbA1C DIRECT</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
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    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-08-02T22:18:07.518Z</lastUpdated>
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    <udiDi>05907514678624</udiDi>
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    <tradeName>A-800 HbA1c DIRECT</tradeName>
    <deviceName>HbA1c DIRECT</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
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    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7-862</reference>
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    <lastUpdated>2026-08-02T22:16:24.565Z</lastUpdated>
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    <udiDi>05907514671120</udiDi>
    <basicUdiDi>B-05907514671120</basicUdiDi>
    <tradeName>A-400 HbA1c DIRECT</tradeName>
    <deviceName>HbA1c DIRECT</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7-112</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:10:11.087Z</lastUpdated>
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    <udiDi>05907514671113</udiDi>
    <basicUdiDi>B-05907514671113</basicUdiDi>
    <tradeName>ACCENT-200 HbA1c DIRECT</tradeName>
    <deviceName>HbA1c DIRECT</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7-111</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:10:07.109Z</lastUpdated>
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    <udiDi>05907514645954</udiDi>
    <basicUdiDi>B-05907514645954</basicUdiDi>
    <tradeName>HC-HbA1c DIRECT</tradeName>
    <deviceName>HbA1c DIRECT</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4-595</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:09:02.238Z</lastUpdated>
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    <udiDi>05907514643011</udiDi>
    <basicUdiDi>B-05907514643011</basicUdiDi>
    <tradeName>PRESTIGE 24i HbA1c DIRECT</tradeName>
    <deviceName>HbA1c DIRECT</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4-301</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:05:24.568Z</lastUpdated>
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    <udiDi>05907514643004</udiDi>
    <basicUdiDi>B-05907514643004</basicUdiDi>
    <tradeName>PRESTIGE 24i HbA1c DIRECT</tradeName>
    <deviceName>HbA1c DIRECT</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4-300</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:05:23.425Z</lastUpdated>
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    <udiDi>05907514633418</udiDi>
    <basicUdiDi>B-05907514633418</basicUdiDi>
    <tradeName>CORMAY HbA1c DIRECT 60</tradeName>
    <deviceName>HbA1c DIRECT</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDD</legislation>
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    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3-341</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T22:01:44.358Z</lastUpdated>
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    <udiDi>05907514602087</udiDi>
    <basicUdiDi>B-05907514602087</basicUdiDi>
    <tradeName>ACCENT-300 HbA1c DIRECT</tradeName>
    <deviceName>HbA1c DIRECT</deviceName>
    <manufacturerName>PZ CORMAY Spółka Akcyjna</manufacturerName>
    <manufacturerSrn>PL-MF-000023053</manufacturerSrn>
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    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7-110</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T21:57:02.305Z</lastUpdated>
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    <udiDi>05404035101698</udiDi>
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    <tradeName>HbA1c Turbi</tradeName>
    <deviceName>HbA1c Turbi</deviceName>
    <manufacturerName>Cypress Diagnostics</manufacturerName>
    <manufacturerSrn>BE-MF-000000033</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HT001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T17:36:39.441Z</lastUpdated>
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    <udiDi>06944904029498</udiDi>
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    <tradeName>Hemoglobin A1c Kit (Enzymatic Assay Method)</tradeName>
    <deviceName>Hemoglobin A1c Kit (Enzymatic Assay Method)、Hemoglobin A1c calibrator、Hemoglobin A1c control</deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105-002166-00</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:43:52.286Z</lastUpdated>
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    <tradeName>HbA1c</tradeName>
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    <manufacturerName>Thermo Fisher Scientific Oy</manufacturerName>
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    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-31T15:02:27.339Z</lastUpdated>
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    <tradeName>HSi Hemolysis &amp; Wash Solution-(L)</tradeName>
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    <manufacturerName>Tosoh Europe N.V.</manufacturerName>
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    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>018431L</reference>
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    <lastUpdated>2026-07-31T07:57:44.815Z</lastUpdated>
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    <tradeName>HbA1c ΔΙΑΛΥΜΑ ΑΙΜΟΛΥΣΗΣ 1x100 ml</tradeName>
    <deviceName>DILUTING SOLUTION</deviceName>
    <manufacturerName>Biotechnological Applications Ltd</manufacturerName>
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    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001781</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-07-31T06:46:00.038Z</lastUpdated>
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