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    <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>
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  <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>
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    <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>
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    <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>
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    <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>
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  <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>
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    <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>
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  <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>
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  <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>
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  <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>
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  <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>
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  <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>
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  <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>
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  <row>
    <udiDi>D-465915RA</udiDi>
    <basicUdiDi>B-465915RA</basicUdiDi>
    <tradeName>SYNCHRON Systems Bilirubin Calibrator</tradeName>
    <deviceName>SYNCHRON Systems Bilirubin 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>465915</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:52:25.714Z</lastUpdated>
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    <udiDi>D-445930QG</udiDi>
    <basicUdiDi>B-445930QG</basicUdiDi>
    <tradeName>SYNCHRON® Systems Microprotein Calibrator</tradeName>
    <deviceName>SYNCHRON® Systems Microprotein 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>445930</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:46:55.789Z</lastUpdated>
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  <row>
    <udiDi>D-105730MK</udiDi>
    <basicUdiDi>B-105730MK</basicUdiDi>
    <tradeName>CALIBRATOR 90</tradeName>
    <deviceName>CALIBRATOR 90</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>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>105730</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:28:03.861Z</lastUpdated>
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    <udiDi>D-101714LR</udiDi>
    <basicUdiDi>B-101714LR</basicUdiDi>
    <tradeName>CALIBRATOR Lite</tradeName>
    <deviceName>CALIBRATOR Lite</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>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>101714</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-10T21:48:10.689Z</lastUpdated>
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    <udiDi>06947145571924</udiDi>
    <basicUdiDi>69471455597X9</basicUdiDi>
    <tradeName>Biossays Direct Bilirubin (Diazo with Dichloroaniline)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130502016S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T03:44:59.903Z</lastUpdated>
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    <udiDi>06947145545987</udiDi>
    <basicUdiDi>69471455597X9</basicUdiDi>
    <tradeName>Biossays Direct Bilirubin (Diazo with Dichloroaniline)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>130502016A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T03:44:58.679Z</lastUpdated>
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    <udiDi>06947145545963</udiDi>
    <basicUdiDi>69471455597X9</basicUdiDi>
    <tradeName>Biossays Direct Bilirubin Controls</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen New Industries Biomedical Engineering Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000005655</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101050302</emdnCode>
    <emdnDescription>CALIBRATORS SINGLE COMPONENT (CC)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>160202597Q</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T03:44:58.634Z</lastUpdated>
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