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    <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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    <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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    <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>D-084360386136135EH</udiDi>
    <basicUdiDi>B-084360386136135EH</basicUdiDi>
    <tradeName>Hemoglobin 50X, R: 4 x 5 mL, CAL: 1 x 1 mL</tradeName>
    <deviceName>Hemoglobin 50X, R: 4 x 5 mL, CAL: 1 x 1 mL</deviceName>
    <manufacturerName>Chronolab Systems, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000017043</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010201</emdnCode>
    <emdnDescription>HAEMOGLOBIN DETERMINATIONS (TOTAL HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101-0368</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T21:30:28.749Z</lastUpdated>
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    <udiDi>06975867980038</udiDi>
    <basicUdiDi>B-06975867980038</basicUdiDi>
    <tradeName>Fecal Occult Blood (FOB) Test Kit (LIA)</tradeName>
    <deviceName>Fecal Occult Blood (FOB) Test Kit (LIA)</deviceName>
    <manufacturerName>Hunan Hehao Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029298</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010201</emdnCode>
    <emdnDescription>HAEMOGLOBIN DETERMINATIONS (TOTAL HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BQX2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:16:20.769Z</lastUpdated>
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    <udiDi>06975867980021</udiDi>
    <basicUdiDi>B-06975867980021</basicUdiDi>
    <tradeName>Fecal Occult Blood (FOB) Test Kit (LIA)</tradeName>
    <deviceName>Fecal Occult Blood (FOB) Test Kit (LIA)</deviceName>
    <manufacturerName>Hunan Hehao Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029298</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010201</emdnCode>
    <emdnDescription>HAEMOGLOBIN DETERMINATIONS (TOTAL HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BQX1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-06T21:16:19.968Z</lastUpdated>
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    <udiDi>08908015864100</udiDi>
    <basicUdiDi>8908015864HBCHEKSTRIPCD</basicUdiDi>
    <tradeName>HbChek</tradeName>
    <deviceName>Hemoglobin Microcuvette / Test Strips - A Reagent less Specimen Receptacle</deviceName>
    <manufacturerName>Biosense Technologies Private Limited.</manufacturerName>
    <manufacturerSrn>IN-MF-000052180</manufacturerSrn>
    <authorisedRepresentativeName>MD&amp;D Alliance GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000045389</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010201</emdnCode>
    <emdnDescription>HAEMOGLOBIN DETERMINATIONS (TOTAL HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FG00053</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:07:25.462Z</lastUpdated>
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    <udiDi>08595142206509</udiDi>
    <basicUdiDi>85951422128307N</basicUdiDi>
    <tradeName>DRABKIN ROZTOK</tradeName>
    <deviceName>DRABKIN ROZTOK</deviceName>
    <manufacturerName>Ing. Petr Švec - PENTA s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000035988</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010201</emdnCode>
    <emdnDescription>HAEMOGLOBIN DETERMINATIONS (TOTAL HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>12830</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:54:23.707Z</lastUpdated>
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  <row>
    <udiDi>06975867980007</udiDi>
    <basicUdiDi>695786798BQX01XK</basicUdiDi>
    <tradeName>Fecal Occult Blood (FOB) Test Kit (LIA)</tradeName>
    <deviceName>Fecal Occult Blood (FOB) Test Kit (LIA)</deviceName>
    <manufacturerName>Hunan Hehao Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000029298</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010201</emdnCode>
    <emdnDescription>HAEMOGLOBIN DETERMINATIONS (TOTAL HB)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BQX1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T08:02:56.860Z</lastUpdated>
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