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    <basicUdiDi>6970493090608006PW</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>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XQ-0007-02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:20:08.808Z</lastUpdated>
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  <row>
    <udiDi>06970493096429</udiDi>
    <basicUdiDi>6970493090608005PU</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>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XQ-0005-01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T18:20:04.808Z</lastUpdated>
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    <udiDi>00630414473413</udiDi>
    <basicUdiDi>0405686900800VB</basicUdiDi>
    <tradeName>ADVIA 120/2120/2120i 3•in•1 TESTpoint Hematology Controls (ABN2 Control)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_TESTpoint 3-in-1 Con Abnor 2</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10318905</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:41:00.139Z</lastUpdated>
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    <udiDi>00630414473406</udiDi>
    <basicUdiDi>0405686900801VD</basicUdiDi>
    <tradeName>ADVIA 120/2120/2120i 3•in•1 TESTpoint Hematology Controls (ABN1 Control)</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_B_REAG_TESTpt 3-in -1 Control Abnor 1</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10330063</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T19:40:59.325Z</lastUpdated>
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  <row>
    <udiDi>00630414222905</udiDi>
    <basicUdiDi>0405686900767W6</basicUdiDi>
    <tradeName>ADVIA 120/2120/2120i® autoRETIC</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_REAG_autoRETIC</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10330709</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:13:06.003Z</lastUpdated>
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  <row>
    <udiDi>D-BI00004236B</udiDi>
    <basicUdiDi>B-BI00004236B</basicUdiDi>
    <tradeName>B-Trol ESR Control L2</tradeName>
    <deviceName>B-Trol ESR Control L2</deviceName>
    <manufacturerName>Labquality Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000019825</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BI0000423</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:24:34.495Z</lastUpdated>
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    <udiDi>D-BI000042269</udiDi>
    <basicUdiDi>B-BI000042269</basicUdiDi>
    <tradeName>B-Trol ESR Control L2</tradeName>
    <deviceName>B-Trol ESR Control L2</deviceName>
    <manufacturerName>Labquality Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000019825</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BI0000422</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:24:33.693Z</lastUpdated>
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    <udiDi>D-BI000017269</udiDi>
    <basicUdiDi>B-BI000017269</basicUdiDi>
    <tradeName>B-Trol Plus Control Abnormal Level</tradeName>
    <deviceName>B-Trol Plus Control Abnormal Level</deviceName>
    <manufacturerName>Labquality Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000019825</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>BI0000172</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-13T00:24:28.105Z</lastUpdated>
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  <row>
    <udiDi>D-75470112H</udiDi>
    <basicUdiDi>B-75470112H</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>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7547011</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:09:42.864Z</lastUpdated>
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  <row>
    <udiDi>D-75470102F</udiDi>
    <basicUdiDi>B-75470102F</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>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>7547010</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:09:36.896Z</lastUpdated>
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  <row>
    <udiDi>07640142480679</udiDi>
    <basicUdiDi>B-07640142480679</basicUdiDi>
    <tradeName>MYT-3CRP H</tradeName>
    <deviceName>MYT-3CRP H</deviceName>
    <manufacturerName>Orphée SA</manufacturerName>
    <manufacturerSrn>CH-MF-000050926</manufacturerSrn>
    <authorisedRepresentativeName>PZ CORMAY Spółka Akcyjna</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000026245</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MYT3CRP 3H</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:56:32.078Z</lastUpdated>
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    <udiDi>07640142480662</udiDi>
    <basicUdiDi>B-07640142480662</basicUdiDi>
    <tradeName>MYT-3CRP H</tradeName>
    <deviceName>MYT-3CRP H</deviceName>
    <manufacturerName>Orphée SA</manufacturerName>
    <manufacturerSrn>CH-MF-000050926</manufacturerSrn>
    <authorisedRepresentativeName>PZ CORMAY Spółka Akcyjna</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000026245</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MYT3CRP 2H</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:56:28.185Z</lastUpdated>
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  <row>
    <udiDi>07640142480655</udiDi>
    <basicUdiDi>B-07640142480655</basicUdiDi>
    <tradeName>MYT-3CRP H</tradeName>
    <deviceName>MYT-3CRP H</deviceName>
    <manufacturerName>Orphée SA</manufacturerName>
    <manufacturerSrn>CH-MF-000050926</manufacturerSrn>
    <authorisedRepresentativeName>PZ CORMAY Spółka Akcyjna</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000026245</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MYT3CRP 1H</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:56:26.472Z</lastUpdated>
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    <udiDi>07640142480617</udiDi>
    <basicUdiDi>B-07640142480617</basicUdiDi>
    <tradeName>MYT-3CRP L</tradeName>
    <deviceName>MYT-3CRP L</deviceName>
    <manufacturerName>Orphée SA</manufacturerName>
    <manufacturerSrn>CH-MF-000050926</manufacturerSrn>
    <authorisedRepresentativeName>PZ CORMAY Spółka Akcyjna</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000026245</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MYT3CRP 3L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:56:20.088Z</lastUpdated>
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    <udiDi>07640142480600</udiDi>
    <basicUdiDi>B-07640142480600</basicUdiDi>
    <tradeName>MYT-3CRP L</tradeName>
    <deviceName>MYT-3CRP L</deviceName>
    <manufacturerName>Orphée SA</manufacturerName>
    <manufacturerSrn>CH-MF-000050926</manufacturerSrn>
    <authorisedRepresentativeName>PZ CORMAY Spółka Akcyjna</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000026245</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MYT3CRP 2L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:56:19.263Z</lastUpdated>
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    <udiDi>07640142480594</udiDi>
    <basicUdiDi>B-07640142480594</basicUdiDi>
    <tradeName>MYT-3CRP L</tradeName>
    <deviceName>MYT-3CRP L</deviceName>
    <manufacturerName>Orphée SA</manufacturerName>
    <manufacturerSrn>CH-MF-000050926</manufacturerSrn>
    <authorisedRepresentativeName>PZ CORMAY Spółka Akcyjna</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PL-AR-000026245</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MYT3CRP 1L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-07T02:56:18.469Z</lastUpdated>
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    <udiDi>08592156325325</udiDi>
    <basicUdiDi>8592156H7COR301UQ</basicUdiDi>
    <tradeName>Erba H7 ret CON L</tradeName>
    <deviceName>Erba H7 ret CON</deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEM00060</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:25:56.433Z</lastUpdated>
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    <udiDi>08592156325288</udiDi>
    <basicUdiDi>8592156H7CON301TU</basicUdiDi>
    <tradeName>Erba H7 CON L</tradeName>
    <deviceName>Erba H7 CON</deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEM00056</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:25:55.630Z</lastUpdated>
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    <udiDi>08592156140454</udiDi>
    <basicUdiDi>8592156HECON30432</basicUdiDi>
    <tradeName>Erba H3 CON L</tradeName>
    <deviceName>Erba H3 CON</deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEM00033</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:25:47.626Z</lastUpdated>
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    <udiDi>08592156113182</udiDi>
    <basicUdiDi>8592156HECON3032Y</basicUdiDi>
    <tradeName>ELite H5 CON L</tradeName>
    <deviceName>ELite H5 CON</deviceName>
    <manufacturerName>Erba Lachema s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000024067</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0103010502</emdnCode>
    <emdnDescription>ABNORMAL BLOOD CONTROLS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HEM00024</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:25:25.187Z</lastUpdated>
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