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<eudamedExport entity="devices">
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    <basicUdiDi>B-62230041023632</basicUdiDi>
    <tradeName>Haemoglobin (Ready to Use)</tradeName>
    <deviceName>Haemoglobin (Ready to Use)</deviceName>
    <manufacturerName>Egyptian Company For Biotechnology-Spectrum Diagnostics</manufacturerName>
    <manufacturerSrn>EG-MF-000032599</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010201</emdnCode>
    <emdnDescription>HAEMOGLOBIN DETERMINATIONS (TOTAL HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>611 002</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:24:51.345Z</lastUpdated>
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    <udiDi>62230041023564</udiDi>
    <basicUdiDi>B-62230041023564</basicUdiDi>
    <tradeName>Haemoglobin (Ready to Use)</tradeName>
    <deviceName>Haemoglobin (Ready to Use)</deviceName>
    <manufacturerName>Egyptian Company For Biotechnology-Spectrum Diagnostics</manufacturerName>
    <manufacturerSrn>EG-MF-000032599</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010201</emdnCode>
    <emdnDescription>HAEMOGLOBIN DETERMINATIONS (TOTAL HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>611 001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:24:47.704Z</lastUpdated>
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    <udiDi>06975984066288</udiDi>
    <basicUdiDi>69703416803202023HJ</basicUdiDi>
    <tradeName>Eluent D</tradeName>
    <deviceName>Eluent D</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010299</emdnCode>
    <emdnDescription>OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320203007</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:03:48.652Z</lastUpdated>
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    <udiDi>06975984066165</udiDi>
    <basicUdiDi>69703416803202022HG</basicUdiDi>
    <tradeName>Eluent C</tradeName>
    <deviceName>Eluent C</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010299</emdnCode>
    <emdnDescription>OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320202905</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:03:46.326Z</lastUpdated>
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    <udiDi>06975984066141</udiDi>
    <basicUdiDi>69703416803202021HE</basicUdiDi>
    <tradeName>Eluent B</tradeName>
    <deviceName>Eluent B</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010299</emdnCode>
    <emdnDescription>OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320202805</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:03:44.656Z</lastUpdated>
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    <udiDi>06975984066127</udiDi>
    <basicUdiDi>69703416803202020HC</basicUdiDi>
    <tradeName>Eluent A</tradeName>
    <deviceName>Eluent A</deviceName>
    <manufacturerName>Shenzhen Lifotronic Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005654</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010299</emdnCode>
    <emdnDescription>OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0320202707</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T08:03:43.848Z</lastUpdated>
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    <udiDi>D-VOS01-0129B</udiDi>
    <basicUdiDi>B-VOS01-0129B</basicUdiDi>
    <tradeName>Vivadiag Plus</tradeName>
    <deviceName></deviceName>
    <manufacturerName>VivaChek Biotech (Hangzhou) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000012160</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010201</emdnCode>
    <emdnDescription>HAEMOGLOBIN DETERMINATIONS (TOTAL HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VOS01-012</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:24:48.257Z</lastUpdated>
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  <row>
    <udiDi>D-SL-80-HB8B</udiDi>
    <basicUdiDi>B-SL-80-HB8B</basicUdiDi>
    <tradeName>D-SL-80-HB8B</tradeName>
    <deviceName>Hemoglobin electrophoresis kit 80 tests</deviceName>
    <manufacturerName>Seleo S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000045668</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010202</emdnCode>
    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL-80-HB</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:30:39.201Z</lastUpdated>
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  <row>
    <udiDi>D-SL-200-HBMA</udiDi>
    <basicUdiDi>B-SL-200-HBMA</basicUdiDi>
    <tradeName>D-SL-200-HBMA</tradeName>
    <deviceName>Hemoglobin electrophoresis kit 200 tests</deviceName>
    <manufacturerName>Seleo S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000045668</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010202</emdnCode>
    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL-200-HB</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:30:27.992Z</lastUpdated>
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  <row>
    <udiDi>D-SL-200-HB/22J</udiDi>
    <basicUdiDi>B-SL-200-HB/22J</basicUdiDi>
    <tradeName>D-SL-200-HB/22J</tradeName>
    <deviceName>Hemoglobin electrophoresis kit 200 tests 4 samples</deviceName>
    <manufacturerName>Seleo S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000045668</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010202</emdnCode>
    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL-200-HB/2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:30:27.192Z</lastUpdated>
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  <row>
    <udiDi>D-SL-100-HB/2ZU</udiDi>
    <basicUdiDi>B-SL-100-HB/2ZU</basicUdiDi>
    <tradeName>D-SL-100-HB/2ZU</tradeName>
    <deviceName>Hemoglobin electrophoresis kit 100 tests 4 samples</deviceName>
    <manufacturerName>Seleo S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000045668</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010202</emdnCode>
    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL-100-HB/2</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T03:30:10.216Z</lastUpdated>
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  <row>
    <udiDi>08809446081992</udiDi>
    <basicUdiDi>B-08809446081992</basicUdiDi>
    <tradeName>08809446081992</tradeName>
    <deviceName>careSTART™ Hb1 Strip</deviceName>
    <manufacturerName>WELLS BIO, INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000031789</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010201</emdnCode>
    <emdnDescription>HAEMOGLOBIN DETERMINATIONS (TOTAL HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BHP-E02582</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:10:04.721Z</lastUpdated>
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  <row>
    <udiDi>08809446080155</udiDi>
    <basicUdiDi>B-08809446080155</basicUdiDi>
    <tradeName>08809446080155</tradeName>
    <deviceName>careSTART™ S1 Hb Strip</deviceName>
    <manufacturerName>WELLS BIO, INC.</manufacturerName>
    <manufacturerSrn>KR-MF-000031789</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010201</emdnCode>
    <emdnDescription>HAEMOGLOBIN DETERMINATIONS (TOTAL HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BSH-E02582</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:09:50.308Z</lastUpdated>
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  <row>
    <udiDi>08800065140220</udiDi>
    <basicUdiDi>B-08800065140220</basicUdiDi>
    <tradeName>CERA-CHEK™  3 in 1 GHL Hemoglobin Test Strip</tradeName>
    <deviceName>Hemoglobin Test Strip</deviceName>
    <manufacturerName>GC MEDIS Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000012638</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste B</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010201</emdnCode>
    <emdnDescription>HAEMOGLOBIN DETERMINATIONS (TOTAL HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M400S11</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:02.436Z</lastUpdated>
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    <udiDi>08800065140022</udiDi>
    <basicUdiDi>B-08800065140022</basicUdiDi>
    <tradeName>CERA-CHEK™ Hb Plus Hemoglobin Test Strip</tradeName>
    <deviceName>CERA-CHEK™ Hb Plus Hemoglobin Test Strip</deviceName>
    <manufacturerName>GC MEDIS Corp.</manufacturerName>
    <manufacturerSrn>KR-MF-000012638</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010201</emdnCode>
    <emdnDescription>HAEMOGLOBIN DETERMINATIONS (TOTAL HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B400S10</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-10T02:12:01.625Z</lastUpdated>
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    <udiDi>08719327450901</udiDi>
    <basicUdiDi>B-08719327450901</basicUdiDi>
    <tradeName>FMH QuikQuant</tradeName>
    <deviceName>FMH QuikQuant</deviceName>
    <manufacturerName>IQ Products BV</manufacturerName>
    <manufacturerSrn>NL-MF-000010812</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010202</emdnCode>
    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>QQF-100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-09T16:05:27.335Z</lastUpdated>
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    <udiDi>08683555618931</udiDi>
    <basicUdiDi>B-08683555618931</basicUdiDi>
    <tradeName>HbA1c Kit</tradeName>
    <deviceName>HbA1c Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010202</emdnCode>
    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B28177</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:50:26.604Z</lastUpdated>
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    <udiDi>08683555618924</udiDi>
    <basicUdiDi>B-08683555618924</basicUdiDi>
    <tradeName>HbA1c Kit</tradeName>
    <deviceName>HbA1c Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010202</emdnCode>
    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B28176</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:50:25.809Z</lastUpdated>
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    <udiDi>08683555618917</udiDi>
    <basicUdiDi>B-08683555618917</basicUdiDi>
    <tradeName>HbA1c Kit</tradeName>
    <deviceName>HbA1c Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010202</emdnCode>
    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B28175</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:50:25.034Z</lastUpdated>
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    <udiDi>08683555614988</udiDi>
    <basicUdiDi>B-08683555614988</basicUdiDi>
    <tradeName>HbA1c Kit</tradeName>
    <deviceName>HbA1c+Lyse Kit</deviceName>
    <manufacturerName>KİNETİK BİLİŞİM DİAGNOSTİK ANONİM ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000040334</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010202</emdnCode>
    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B29175</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-08T21:39:56.554Z</lastUpdated>
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