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<eudamedExport entity="devices">
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    <tradeName>Coulter 5C Cell Control</tradeName>
    <deviceName>Coulter 5C Cell 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>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>624506</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-17T00:38:38.563Z</lastUpdated>
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    <udiDi>06941377306989</udiDi>
    <basicUdiDi>697049309W01033013001CB</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName>Hematology Control</deviceName>
    <manufacturerName>Shenzhen Dymind Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024842</manufacturerSrn>
    <authorisedRepresentativeName>Eunitor GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005081</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XQ-0093-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:56:47.427Z</lastUpdated>
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  <row>
    <udiDi>00844509000648</udiDi>
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    <tradeName>Streck</tradeName>
    <deviceName>Para 12 EXT - 18 x 2.5 mL (6 Low, 6 Normal, 6 High)</deviceName>
    <manufacturerName>Streck</manufacturerName>
    <manufacturerSrn>US-MF-000013009</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>218750</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:20:42.799Z</lastUpdated>
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    <udiDi>00844509000358</udiDi>
    <basicUdiDi>08445090STKRQM</basicUdiDi>
    <tradeName>Streck</tradeName>
    <deviceName>STaK-Chex Plus Retics - 4x4.5ml Low</deviceName>
    <manufacturerName>Streck</manufacturerName>
    <manufacturerSrn>US-MF-000013009</manufacturerSrn>
    <authorisedRepresentativeName>MediMark Europe Sarl.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000182</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>225485</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T02:20:39.737Z</lastUpdated>
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    <udiDi>00815762024153</udiDi>
    <basicUdiDi>0815762020RIBS</basicUdiDi>
    <tradeName>R&amp;D Retic-I</tradeName>
    <deviceName>R&amp;D Retic-I</deviceName>
    <manufacturerName>R&amp;D Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024485</manufacturerSrn>
    <authorisedRepresentativeName>BIO-TECHNE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011963</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Many</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:19:38.810Z</lastUpdated>
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    <udiDi>00815762021220</udiDi>
    <basicUdiDi>0081576202RI00QM</basicUdiDi>
    <tradeName>R&amp;D Retic-I</tradeName>
    <deviceName>R&amp;D Retic-I</deviceName>
    <manufacturerName>R&amp;D Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024485</manufacturerSrn>
    <authorisedRepresentativeName>BIO-TECHNE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011963</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RI001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:20:47.656Z</lastUpdated>
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    <udiDi>D-QS2102-01PJ</udiDi>
    <basicUdiDi>B-QS2102-01PJ</basicUdiDi>
    <tradeName>D-QS2102-01PJ</tradeName>
    <deviceName>Hematology Control</deviceName>
    <manufacturerName>SHENZHEN REETOO BIOTECHNOLOGY CO., LTD</manufacturerName>
    <manufacturerSrn>CN-MF-000011699</manufacturerSrn>
    <authorisedRepresentativeName>Umedwings Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000444</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>/</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T02:23:17.586Z</lastUpdated>
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  <row>
    <udiDi>D-C07297V5</udiDi>
    <basicUdiDi>B-C07297V5</basicUdiDi>
    <tradeName>COULTER 6C Plus Cell Control</tradeName>
    <deviceName>COULTER 6C Plus Cell 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>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C07297</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:50:28.005Z</lastUpdated>
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  <row>
    <udiDi>D-75471993W</udiDi>
    <basicUdiDi>B-75471993W</basicUdiDi>
    <tradeName>Coulter 5C Cell Control</tradeName>
    <deviceName>Coulter 5C Cell 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>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7547199</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:10:13.775Z</lastUpdated>
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  <row>
    <udiDi>D-75471983U</udiDi>
    <basicUdiDi>B-75471983U</basicUdiDi>
    <tradeName>COULTER Ac•T 5diff Control Plus</tradeName>
    <deviceName>COULTER Ac•T 5diff Control Plus</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>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7547198</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:10:12.179Z</lastUpdated>
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  <row>
    <udiDi>D-75471242X</udiDi>
    <basicUdiDi>B-75471242X</basicUdiDi>
    <tradeName>Coulter 5C Cell Control</tradeName>
    <deviceName>Coulter 5C Cell 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>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7547124</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:10:03.369Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-754711732</udiDi>
    <basicUdiDi>B-754711732</basicUdiDi>
    <tradeName>Coulter 5C Cell Control</tradeName>
    <deviceName>Coulter 5C Cell 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>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7547117</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:09:44.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-75471162Y</udiDi>
    <basicUdiDi>B-75471162Y</basicUdiDi>
    <tradeName>Coulter 5C Cell Control</tradeName>
    <deviceName>Coulter 5C Cell 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>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7547116</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:09:43.311Z</lastUpdated>
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  <row>
    <udiDi>D-75470012E</udiDi>
    <basicUdiDi>B-75470012E</basicUdiDi>
    <tradeName>Coulter 5C Cell Control</tradeName>
    <deviceName>Coulter 5C Cell 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>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7547001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:09:36.096Z</lastUpdated>
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  <row>
    <udiDi>10815762020343</udiDi>
    <basicUdiDi>B-10815762020343</basicUdiDi>
    <tradeName>CBC-7 Hematology Control</tradeName>
    <deviceName>CBC-7B</deviceName>
    <manufacturerName>R&amp;D Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024485</manufacturerSrn>
    <authorisedRepresentativeName>BIO-TECHNE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011963</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>72001</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:26:40.934Z</lastUpdated>
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  <row>
    <udiDi>10815762020091</udiDi>
    <basicUdiDi>B-10815762020091</basicUdiDi>
    <tradeName>CBC-3D Hematology Control</tradeName>
    <deviceName>CBC-3D1</deviceName>
    <manufacturerName>R&amp;D Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024485</manufacturerSrn>
    <authorisedRepresentativeName>BIO-TECHNE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011963</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3D501</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-11T00:26:35.340Z</lastUpdated>
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    <udiDi>06944413815834</udiDi>
    <basicUdiDi>69444138HematoryCon60DAJ</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ED-60D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:51:09.424Z</lastUpdated>
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    <udiDi>06944413815841</udiDi>
    <basicUdiDi>69444138HematoryCon30DA3</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ED-30D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:51:09.389Z</lastUpdated>
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    <udiDi>06944413815865</udiDi>
    <basicUdiDi>69444138HematoryCon60DAJ</basicUdiDi>
    <tradeName>Hematology Control</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Edan Instruments,Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000009957</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ED-60D</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-09T17:51:09.338Z</lastUpdated>
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    <udiDi>00815762021251</udiDi>
    <basicUdiDi>0081576202RI00QM</basicUdiDi>
    <tradeName>R&amp;D Retic-I</tradeName>
    <deviceName></deviceName>
    <manufacturerName>R&amp;D Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000024485</manufacturerSrn>
    <authorisedRepresentativeName>BIO-TECHNE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011963</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010503</emdnCode>
    <emdnDescription>MULTILEVEL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RI005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T02:28:51.940Z</lastUpdated>
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