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<eudamedExport entity="devices">
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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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  <row>
    <udiDi>08034063842934</udiDi>
    <basicUdiDi>B-08034063842934</basicUdiDi>
    <tradeName>HEMOGLOBIN A2</tradeName>
    <deviceName>HEMOGLOBIN A2</deviceName>
    <manufacturerName>FAR Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000041136</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>KR06-20</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T15:02:23.524Z</lastUpdated>
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  <row>
    <udiDi>06977125152416</udiDi>
    <basicUdiDi>B-06977125152416</basicUdiDi>
    <tradeName>HbA2 &amp; HbF &amp; HbA1c Assay Kit (HPLC)</tradeName>
    <deviceName>HbA2 &amp; HbF &amp; HbA1c Assay Kit (HPLC)</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010299</emdnCode>
    <emdnDescription>OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GHD200</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:11:19.931Z</lastUpdated>
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  <row>
    <udiDi>06977125152409</udiDi>
    <basicUdiDi>B-06977125152409</basicUdiDi>
    <tradeName>HbA2 &amp; HbF &amp; HbA1c Assay Kit (HPLC)</tradeName>
    <deviceName>HbA2 &amp; HbF &amp; HbA1c Assay Kit (HPLC)</deviceName>
    <manufacturerName>Goldsite Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000001353</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010299</emdnCode>
    <emdnDescription>OTHER HAEMOGLOBIN (TYPES) TESTING - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GHD100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-06T22:11:19.112Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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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  <row>
    <udiDi>06975531323673</udiDi>
    <basicUdiDi>B-06975531323673</basicUdiDi>
    <tradeName>06975531323673</tradeName>
    <deviceName>Beta-Thalassemia Analysis  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>W0103010202</emdnCode>
    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:38:11.294Z</lastUpdated>
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  <row>
    <udiDi>06975531323666</udiDi>
    <basicUdiDi>B-06975531323666</basicUdiDi>
    <tradeName>06975531323666</tradeName>
    <deviceName>Beta-Thalassemia Analysis  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>W0103010202</emdnCode>
    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:38:10.502Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975531323659</udiDi>
    <basicUdiDi>B-06975531323659</basicUdiDi>
    <tradeName>06975531323659</tradeName>
    <deviceName>Beta-Thalassemia Analysis  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>W0103010202</emdnCode>
    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:38:09.695Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975531323642</udiDi>
    <basicUdiDi>B-06975531323642</basicUdiDi>
    <tradeName>06975531323642</tradeName>
    <deviceName>Beta-Thalassemia Analysis  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>W0103010202</emdnCode>
    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:38:05.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975531323635</udiDi>
    <basicUdiDi>B-06975531323635</basicUdiDi>
    <tradeName>06975531323635</tradeName>
    <deviceName>Beta-Thalassemia Analysis  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>W0103010202</emdnCode>
    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:38:04.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975531323628</udiDi>
    <basicUdiDi>B-06975531323628</basicUdiDi>
    <tradeName>06975531323628</tradeName>
    <deviceName>Beta-Thalassemia Analysis  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>W0103010202</emdnCode>
    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:38:03.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975531323604</udiDi>
    <basicUdiDi>B-06975531323604</basicUdiDi>
    <tradeName>06975531323604</tradeName>
    <deviceName>Beta-Thalassemia Analysis  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>W0103010202</emdnCode>
    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:38:02.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975531323598</udiDi>
    <basicUdiDi>B-06975531323598</basicUdiDi>
    <tradeName>06975531323598</tradeName>
    <deviceName>Beta-Thalassemia Analysis  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>W0103010202</emdnCode>
    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:37:58.483Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975531323581</udiDi>
    <basicUdiDi>B-06975531323581</basicUdiDi>
    <tradeName>06975531323581</tradeName>
    <deviceName>Beta-Thalassemia Analysis  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>W0103010202</emdnCode>
    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:37:57.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975531323574</udiDi>
    <basicUdiDi>B-06975531323574</basicUdiDi>
    <tradeName>06975531323574</tradeName>
    <deviceName>Beta-Thalassemia Analysis  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>W0103010202</emdnCode>
    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:37:56.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975531323567</udiDi>
    <basicUdiDi>B-06975531323567</basicUdiDi>
    <tradeName>06975531323567</tradeName>
    <deviceName>Beta-Thalassemia Analysis  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>W0103010202</emdnCode>
    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:37:55.287Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975531323536</udiDi>
    <basicUdiDi>B-06975531323536</basicUdiDi>
    <tradeName>06975531323536</tradeName>
    <deviceName>Beta-Thalassemia Analysis  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>W0103010202</emdnCode>
    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:37:51.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975531323529</udiDi>
    <basicUdiDi>B-06975531323529</basicUdiDi>
    <tradeName>06975531323529</tradeName>
    <deviceName>Beta-Thalassemia Analysis  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>W0103010202</emdnCode>
    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:37:50.479Z</lastUpdated>
  </row>
  <row>
    <udiDi>06975531323550</udiDi>
    <basicUdiDi>B-06975531323550</basicUdiDi>
    <tradeName>06975531323550</tradeName>
    <deviceName>Beta-Thalassemia Analysis  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>W0103010202</emdnCode>
    <emdnDescription>HAEMOGLOBIN SUBTYPES HBA2, HBC, HBF, HBS, ETC.(EXCL. HBA1)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-06T20:37:49.679Z</lastUpdated>
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</eudamedExport>