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    <tradeName>Control</tradeName>
    <deviceName>Glycated Hemoglobin （HbA1c) Assay Kit (HPLC)</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Control</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:44:05.382Z</lastUpdated>
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    <udiDi>06978465236743</udiDi>
    <basicUdiDi>B-06978465236743</basicUdiDi>
    <tradeName>Calibrator</tradeName>
    <deviceName>Glycated Hemoglobin （HbA1c) Assay Kit (HPLC)</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Calibrator</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:44:03.067Z</lastUpdated>
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    <udiDi>06978465236736</udiDi>
    <basicUdiDi>B-06978465236736</basicUdiDi>
    <tradeName>Glycated Hemoglobin （HbA1c) Assay Kit (HPLC)</tradeName>
    <deviceName>Glycated Hemoglobin （HbA1c) Assay Kit (HPLC)</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Eluent Pack E</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:44:00.654Z</lastUpdated>
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    <udiDi>06978465236712</udiDi>
    <basicUdiDi>B-06978465236712</basicUdiDi>
    <tradeName>Glycated Hemoglobin （HbA1c) Assay Kit (HPLC)</tradeName>
    <deviceName>Glycated Hemoglobin （HbA1c) Assay Kit (HPLC)</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Eluent Pack C</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:43:59.050Z</lastUpdated>
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    <udiDi>06978465236705</udiDi>
    <basicUdiDi>B-06978465236705</basicUdiDi>
    <tradeName>Glycated Hemoglobin （HbA1c) Assay Kit (HPLC</tradeName>
    <deviceName>Glycated Hemoglobin （HbA1c) Assay Kit (HPLC)</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Eluent Pack B</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:43:58.252Z</lastUpdated>
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    <udiDi>06978465236729</udiDi>
    <basicUdiDi>B-06978465236729</basicUdiDi>
    <tradeName>Glycated Hemoglobin （HbA1c) Assay Kit (HPLC)</tradeName>
    <deviceName>Glycated Hemoglobin （HbA1c) Assay Kit (HPLC)</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Eluent Pack D</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:43:56.688Z</lastUpdated>
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    <udiDi>06978465236699</udiDi>
    <basicUdiDi>B-06978465236699</basicUdiDi>
    <tradeName>Glycated Hemoglobin （HbA1c) Assay Kit (HPLC)</tradeName>
    <deviceName>Glycated Hemoglobin （HbA1c) Assay Kit (HPLC)</deviceName>
    <manufacturerName>Shenzhen Dake Medical Technology Co.,Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000047336</manufacturerSrn>
    <authorisedRepresentativeName>HyperCert Limited B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047746</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Eluent Pack A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:43:54.257Z</lastUpdated>
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    <udiDi>06975531323192</udiDi>
    <basicUdiDi>B-06975531323192</basicUdiDi>
    <tradeName>06975531323192</tradeName>
    <deviceName>Glycosylated Hemoglobin (HbA1c)  Assay Kits （HPLC）</deviceName>
    <manufacturerName>AILEX(Hunan)Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043377</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:37:14.412Z</lastUpdated>
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    <udiDi>06975531323185</udiDi>
    <basicUdiDi>B-06975531323185</basicUdiDi>
    <tradeName>06975531323185</tradeName>
    <deviceName>Glycosylated Hemoglobin (HbA1c)  Assay Kits （HPLC）</deviceName>
    <manufacturerName>AILEX(Hunan)Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043377</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:37:09.610Z</lastUpdated>
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  <row>
    <udiDi>06975531323178</udiDi>
    <basicUdiDi>B-06975531323178</basicUdiDi>
    <tradeName>06975531323178</tradeName>
    <deviceName>Glycosylated Hemoglobin (HbA1c)  Assay Kits （HPLC）</deviceName>
    <manufacturerName>AILEX(Hunan)Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043377</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:37:08.795Z</lastUpdated>
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  <row>
    <udiDi>06975531323161</udiDi>
    <basicUdiDi>B-06975531323161</basicUdiDi>
    <tradeName>06975531323161</tradeName>
    <deviceName>Glycosylated Hemoglobin (HbA1c)  Assay Kits （HPLC）</deviceName>
    <manufacturerName>AILEX(Hunan)Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043377</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:37:07.999Z</lastUpdated>
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  <row>
    <udiDi>06975531323154</udiDi>
    <basicUdiDi>B-06975531323154</basicUdiDi>
    <tradeName>06975531323154</tradeName>
    <deviceName>Glycosylated Hemoglobin (HbA1c)  Assay Kits （HPLC）</deviceName>
    <manufacturerName>AILEX(Hunan)Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043377</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:37:07.209Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975531323147</udiDi>
    <basicUdiDi>B-06975531323147</basicUdiDi>
    <tradeName>06975531323147</tradeName>
    <deviceName>Glycosylated Hemoglobin (HbA1c)  Assay Kits （HPLC）</deviceName>
    <manufacturerName>AILEX(Hunan)Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043377</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:37:02.410Z</lastUpdated>
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  <row>
    <udiDi>06975531323130</udiDi>
    <basicUdiDi>B-06975531323130</basicUdiDi>
    <tradeName>06975531323130</tradeName>
    <deviceName>Glycosylated Hemoglobin (HbA1c)  Assay Kits （HPLC）</deviceName>
    <manufacturerName>AILEX(Hunan)Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043377</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:37:01.599Z</lastUpdated>
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  <row>
    <udiDi>06975531323123</udiDi>
    <basicUdiDi>B-06975531323123</basicUdiDi>
    <tradeName>06975531323123</tradeName>
    <deviceName>Glycosylated Hemoglobin (HbA1c)  Assay Kits （HPLC）</deviceName>
    <manufacturerName>AILEX(Hunan)Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043377</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:37:00.796Z</lastUpdated>
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    <udiDi>06975531323116</udiDi>
    <basicUdiDi>B-06975531323116</basicUdiDi>
    <tradeName>06975531323116</tradeName>
    <deviceName>Glycosylated Hemoglobin (HbA1c)  Assay Kits （HPLC）</deviceName>
    <manufacturerName>AILEX(Hunan)Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043377</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:36:59.993Z</lastUpdated>
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    <udiDi>06975531323109</udiDi>
    <basicUdiDi>B-06975531323109</basicUdiDi>
    <tradeName>06975531323109</tradeName>
    <deviceName>Glycosylated Hemoglobin (HbA1c)  Assay Kits （HPLC）</deviceName>
    <manufacturerName>AILEX(Hunan)Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043377</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:36:55.187Z</lastUpdated>
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    <udiDi>06975531323093</udiDi>
    <basicUdiDi>B-06975531323093</basicUdiDi>
    <tradeName>06975531323093</tradeName>
    <deviceName>Glycosylated Hemoglobin (HbA1c)  Assay Kits （HPLC）</deviceName>
    <manufacturerName>AILEX(Hunan)Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043377</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:36:54.386Z</lastUpdated>
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    <udiDi>06975531323086</udiDi>
    <basicUdiDi>B-06975531323086</basicUdiDi>
    <tradeName>06975531323086</tradeName>
    <deviceName>Glycosylated Hemoglobin (HbA1c)  Assay Kits （HPLC）</deviceName>
    <manufacturerName>AILEX(Hunan)Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043377</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:36:53.587Z</lastUpdated>
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    <udiDi>06975531323079</udiDi>
    <basicUdiDi>B-06975531323079</basicUdiDi>
    <tradeName>06975531323079</tradeName>
    <deviceName>Glycosylated Hemoglobin (HbA1c)  Assay Kits （HPLC）</deviceName>
    <manufacturerName>AILEX(Hunan)Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000043377</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01010214</emdnCode>
    <emdnDescription>GLYCOSYLATED/GLYCATED HAEMOGLOBIN (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:36:52.808Z</lastUpdated>
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