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<eudamedExport entity="devices">
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    <udiDi>87205897082286</udiDi>
    <basicUdiDi>B-87205897082286</basicUdiDi>
    <tradeName>HbA1c, ingevroren volbloed Level 2</tradeName>
    <deviceName>HbA1c, ingevroren volbloed</deviceName>
    <manufacturerName>Streekziekenhuis Koningin Beatrix</manufacturerName>
    <manufacturerSrn>NL-MF-000000427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBAFr-01.2</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:22:23.333Z</lastUpdated>
  </row>
  <row>
    <udiDi>87205897082118</udiDi>
    <basicUdiDi>B-87205897082118</basicUdiDi>
    <tradeName>HbA1c, ingevroren volbloed Level 1</tradeName>
    <deviceName>HbA1c, ingevroren volbloed</deviceName>
    <manufacturerName>Streekziekenhuis Koningin Beatrix</manufacturerName>
    <manufacturerSrn>NL-MF-000000427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBAFr-01.1</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:22:23.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>87205897082040</udiDi>
    <basicUdiDi>B-87205897082040</basicUdiDi>
    <tradeName>HbA1c, Lyophilised hemolysate Level High</tradeName>
    <deviceName>HbA1c, Lyophilised hemolysate</deviceName>
    <manufacturerName>Streekziekenhuis Koningin Beatrix</manufacturerName>
    <manufacturerSrn>NL-MF-000000427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBA-02.2 CV</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:22:23.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>87205897081982</udiDi>
    <basicUdiDi>B-87205897081982</basicUdiDi>
    <tradeName>HbA1c, Lyophilised hemolysate Level Low</tradeName>
    <deviceName>HbA1c, Lyophilised hemolysate</deviceName>
    <manufacturerName>Streekziekenhuis Koningin Beatrix</manufacturerName>
    <manufacturerSrn>NL-MF-000000427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBA-02.1 CV</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:22:22.961Z</lastUpdated>
  </row>
  <row>
    <udiDi>87205897081814</udiDi>
    <basicUdiDi>B-87205897081814</basicUdiDi>
    <tradeName>HbA1c, Lyophilised hemolysate Level 1</tradeName>
    <deviceName>HbA1c, Lyophilised hemolysate</deviceName>
    <manufacturerName>Streekziekenhuis Koningin Beatrix</manufacturerName>
    <manufacturerSrn>NL-MF-000000427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBA-02.61_092</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:22:16.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>87205897081746</udiDi>
    <basicUdiDi>B-87205897081746</basicUdiDi>
    <tradeName>HbA1c, Lyophilised hemolysate Level 6</tradeName>
    <deviceName>HbA1c, Lyophilised hemolysate</deviceName>
    <manufacturerName>Streekziekenhuis Koningin Beatrix</manufacturerName>
    <manufacturerSrn>NL-MF-000000427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBA-02.66_092</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:22:16.044Z</lastUpdated>
  </row>
  <row>
    <udiDi>87205897081678</udiDi>
    <basicUdiDi>B-87205897081678</basicUdiDi>
    <tradeName>HbA1c, Lyophilised hemolysate Level 5</tradeName>
    <deviceName>HbA1c, Lyophilised hemolysate</deviceName>
    <manufacturerName>Streekziekenhuis Koningin Beatrix</manufacturerName>
    <manufacturerSrn>NL-MF-000000427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBA-02.65_092</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:22:15.246Z</lastUpdated>
  </row>
  <row>
    <udiDi>87205897081432</udiDi>
    <basicUdiDi>B-87205897081432</basicUdiDi>
    <tradeName>HbA1c, Lyophilised hemolysate Level 4</tradeName>
    <deviceName>HbA1c, Lyophilised hemolysate</deviceName>
    <manufacturerName>Streekziekenhuis Koningin Beatrix</manufacturerName>
    <manufacturerSrn>NL-MF-000000427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBA-02.64_092</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:22:14.466Z</lastUpdated>
  </row>
  <row>
    <udiDi>87205897081364</udiDi>
    <basicUdiDi>B-87205897081364</basicUdiDi>
    <tradeName>HbA1c, Lyophilised hemolysate Level 3</tradeName>
    <deviceName>HbA1c, Lyophilised hemolysate</deviceName>
    <manufacturerName>Streekziekenhuis Koningin Beatrix</manufacturerName>
    <manufacturerSrn>NL-MF-000000427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBA-02.63_092</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:22:10.445Z</lastUpdated>
  </row>
  <row>
    <udiDi>87205897081296</udiDi>
    <basicUdiDi>B-87205897081296</basicUdiDi>
    <tradeName>HbA1c, Lyophilised hemolysate Level 2</tradeName>
    <deviceName>HbA1c, Lyophilised hemolysate</deviceName>
    <manufacturerName>Streekziekenhuis Koningin Beatrix</manufacturerName>
    <manufacturerSrn>NL-MF-000000427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBA-02.62_092</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:22:09.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>87205897081128</udiDi>
    <basicUdiDi>B-87205897081128</basicUdiDi>
    <tradeName>HbA1c, Lyophilised hemolysate Level 1</tradeName>
    <deviceName>HbA1c, Lyophilised hemolysate</deviceName>
    <manufacturerName>Streekziekenhuis Koningin Beatrix</manufacturerName>
    <manufacturerSrn>NL-MF-000000427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBA-01.1_011</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:22:08.839Z</lastUpdated>
  </row>
  <row>
    <udiDi>87205897080992</udiDi>
    <basicUdiDi>B-87205897080992</basicUdiDi>
    <tradeName>HbA1c, Lyophilised hemolysate Level 2</tradeName>
    <deviceName>HbA1c, Lyophilised hemolysate</deviceName>
    <manufacturerName>Streekziekenhuis Koningin Beatrix</manufacturerName>
    <manufacturerSrn>NL-MF-000000427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBA-01.2_011</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:22:04.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>87205897080824</udiDi>
    <basicUdiDi>B-87205897080824</basicUdiDi>
    <tradeName>HbA1c, Lyophilised hemolysate Level High</tradeName>
    <deviceName>HbA1c, Lyophilised hemolysate</deviceName>
    <manufacturerName>Streekziekenhuis Koningin Beatrix</manufacturerName>
    <manufacturerSrn>NL-MF-000000427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBA-04.3</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:22:03.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>87205897080756</udiDi>
    <basicUdiDi>B-87205897080756</basicUdiDi>
    <tradeName>HbA1c, Lyophilised hemolysate Level Low</tradeName>
    <deviceName>HbA1c, Lyophilised hemolysate</deviceName>
    <manufacturerName>Streekziekenhuis Koningin Beatrix</manufacturerName>
    <manufacturerSrn>NL-MF-000000427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBA-04.1</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:22:03.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>87205897080060</udiDi>
    <basicUdiDi>B-87205897080060</basicUdiDi>
    <tradeName>HbA1c, Frozen Whole Blood set</tradeName>
    <deviceName>HbA1c, Fozen Whole Blood</deviceName>
    <manufacturerName>Streekziekenhuis Koningin Beatrix</manufacturerName>
    <manufacturerSrn>NL-MF-000000427</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HBAFr-03</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:21:56.836Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8697643491559JD</udiDi>
    <basicUdiDi>B-8697643491559JD</basicUdiDi>
    <tradeName>bt products</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BİLİMSEL TIBBİ ÜRÜNLER PAZARLAMA SANAYİ VE TİCARET LİMİTED ŞİRKETİ</manufacturerName>
    <manufacturerSrn>TR-MF-000017223</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SALB-103</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T14:28:03.472Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77964KK</udiDi>
    <basicUdiDi>B-77964KK</basicUdiDi>
    <tradeName>SPOTCHEM D Calibrator Kit</tradeName>
    <deviceName>SPOTCHEM D Calibrator Kit</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>77964</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:25:20.368Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-77041IS6</udiDi>
    <basicUdiDi>B-77041IS6</basicUdiDi>
    <tradeName>SPOTCHEM CALIBRATOR KIT</tradeName>
    <deviceName>SPOTCHEM CALIBRATOR KIT</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>77041I</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:19:20.554Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-475089R5</udiDi>
    <basicUdiDi>B-475089R5</basicUdiDi>
    <tradeName>SYNCHRON Systems MA Calibrator</tradeName>
    <deviceName>SYNCHRON Systems MA Calibrator</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>475089</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:06:05.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-474988S9</udiDi>
    <basicUdiDi>B-474988S9</basicUdiDi>
    <tradeName>SYNCHRON Systems OP 300 Low Urine Control</tradeName>
    <deviceName>SYNCHRON Systems OP 300 Low Urine Control</deviceName>
    <manufacturerName>Beckman Coulter Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000010288</manufacturerSrn>
    <authorisedRepresentativeName>Beckman Coulter Ireland Inc.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000886</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0101050301</emdnCode>
    <emdnDescription>CALIBRATORS MULTICOMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>474988</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T17:04:51.517Z</lastUpdated>
  </row>
</eudamedExport>