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    <deviceName>GBC Chemiluminescence Analyzer (Non-Sterile)</deviceName>
    <manufacturerName>General Biologicals Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000024694</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T06:31:23.782Z</lastUpdated>
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    <basicUdiDi>0697454654C1800W8</basicUdiDi>
    <tradeName>Aucheer iMAGIN 1800 Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName>Aucheer iMAGIN 1800 Chemiluminescence Immunoassay Analyzer</deviceName>
    <manufacturerName>NINGBO AUCHEER BIOTECHNOLOGY CO.,LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000038081</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
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    <tradeName>IMMULITE® 2000 XPi Immunoassay System</tradeName>
    <deviceName>IVDR_67_LLB_DUB-C_A_INST_XPi</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Products Ltd.</manufacturerName>
    <manufacturerSrn>GB-MF-000016339</manufacturerSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>10373214</reference>
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    <tradeName>Atellica IM 1300 Analyzer</tradeName>
    <deviceName>IVDR_67_TTN_DUB-C_A_INST_1300 Analyzer</deviceName>
    <manufacturerName>Siemens Healthcare Diagnostics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000016560</manufacturerSrn>
    <authorisedRepresentativeName>Siemens Healthcare Diagnostics Manufacturing Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006763</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020102</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>11066001</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:22:24.752Z</lastUpdated>
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    <udiDi>06944904047591</udiDi>
    <basicUdiDi>69449040MYYQ-BM10******9M</basicUdiDi>
    <tradeName>Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020102</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL-2000i</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:39.646Z</lastUpdated>
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    <udiDi>06944904061597</udiDi>
    <basicUdiDi>69449040MYYQ-BM20******A8</basicUdiDi>
    <tradeName>Chemiluminescence Immunoassay Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Shenzhen Mindray Bio-Medical Electronics Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
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    <emdnCode>W0201020102</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:26.219Z</lastUpdated>
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    <tradeName>Chemiluminescence Immunoassay Analyzer</tradeName>
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    <manufacturerSrn>CN-MF-000014156</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL-1000i</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:26.091Z</lastUpdated>
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    <tradeName>STANDARD™ i Wash buffer</tradeName>
    <deviceName>STANDARD™ i Wash buffer</deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16WB10</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:32:46.724Z</lastUpdated>
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    <tradeName>STANDARD™ i2000</tradeName>
    <deviceName>STANDARD™ i2000</deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16IA200</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:30:27.297Z</lastUpdated>
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    <udiDi>08800111720253</udiDi>
    <basicUdiDi>88001117IPAA01IA01V6</basicUdiDi>
    <tradeName>STANDARD™ i1000</tradeName>
    <deviceName>STANDARD™ i1000</deviceName>
    <manufacturerName>SD Biosensor Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000009168</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16IA100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:30:26.492Z</lastUpdated>
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    <tradeName>QUANTA-Lyser® 3000 IFA</tradeName>
    <deviceName>QUANTA-Lyser® 3000 IFA</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS3002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:12:57.163Z</lastUpdated>
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    <tradeName>QUANTA-Lyser® 3000 ELISA/IFA + Incubator</tradeName>
    <deviceName>QUANTA-Lyser® 3000 ELISA/IFA + Incubator</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
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    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS3000i</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:12:55.571Z</lastUpdated>
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    <tradeName>QUANTA-Lyser® 3000 ELISA/IFA</tradeName>
    <deviceName>QUANTA-Lyser® 3000  ELISA/IFA</deviceName>
    <manufacturerName>Inova Diagnostics. Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017851</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
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    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS3000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:12:52.380Z</lastUpdated>
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    <tradeName>AP22 IF BLOT ELITE</tradeName>
    <deviceName>AP ELISA-IFA-BLOT</deviceName>
    <manufacturerName>DAS Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000035583</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-102403</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:36:20.555Z</lastUpdated>
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    <manufacturerName>DAS Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000035583</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-102402</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:36:18.168Z</lastUpdated>
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    <tradeName>AP22 ELITE</tradeName>
    <deviceName>AP ELISA</deviceName>
    <manufacturerName>DAS Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000035583</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:36:16.559Z</lastUpdated>
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    <deviceName>AP BLOT</deviceName>
    <manufacturerName>DAS Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000035583</manufacturerSrn>
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    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-1013112</reference>
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    <lastUpdated>2026-07-03T09:36:15.768Z</lastUpdated>
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    <manufacturerName>DAS Srl</manufacturerName>
    <manufacturerSrn>IT-MF-000035583</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-1166011</reference>
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    <lastUpdated>2026-07-03T09:36:14.152Z</lastUpdated>
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    <tradeName>AP16 IF ELITE</tradeName>
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    <manufacturerSrn>IT-MF-000035583</manufacturerSrn>
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    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OR-101600</reference>
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    <lastUpdated>2026-07-03T09:36:11.752Z</lastUpdated>
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    <tradeName>AL1200 analyzer 120</tradeName>
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    <manufacturerName>Technogenetics S.p.A</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
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    <lastUpdated>2026-07-03T07:04:42.131Z</lastUpdated>
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