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    <tradeName>Fluorescence Immunoassay Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACA204</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:58:17.253Z</lastUpdated>
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    <udiDi>00810186846428</udiDi>
    <basicUdiDi>0810047980010AG7</basicUdiDi>
    <tradeName>Fluorescence Immunoassay Analyzer</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Acro Biotech Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017832</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ACA204</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T19:58:16.814Z</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>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL-1200i</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:26.219Z</lastUpdated>
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    <udiDi>06944904064796</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>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0201020102</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - MODERATE ROUTINE (Throughput &gt; 100 and &lt;= 250 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CL-1000i</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T02:10:26.091Z</lastUpdated>
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    <udiDi>08906194470068</udiDi>
    <basicUdiDi>890619447LM007FB</basicUdiDi>
    <tradeName>LordsMed CLIA Reader</tradeName>
    <deviceName>CLIA Reader</deviceName>
    <manufacturerName>Lord's Mark Industries Private Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000048403</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LM007</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T18:54:05.192Z</lastUpdated>
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    <udiDi>08809446480276</udiDi>
    <basicUdiDi>880944648QST09SA</basicUdiDi>
    <tradeName>Q-STATION ELITE</tradeName>
    <deviceName>Q-STATION ELITE</deviceName>
    <manufacturerName>PROTIA Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000026040</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MQST0901</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:57:14.502Z</lastUpdated>
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    <udiDi>08809408861624</udiDi>
    <basicUdiDi>88094088SBF-001NQ</basicUdiDi>
    <tradeName>08809408861624</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Sugentech, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000023952</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SBFD001E</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:56:36.314Z</lastUpdated>
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    <udiDi>08809317540207</udiDi>
    <basicUdiDi>880931754FRENDKQ</basicUdiDi>
    <tradeName>FREND System</tradeName>
    <deviceName>FREND System</deviceName>
    <manufacturerName>NanoEntek, Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000021903</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F10</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:55:16.693Z</lastUpdated>
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    <udiDi>08800111722691</udiDi>
    <basicUdiDi>88001117IPAA05IA01WJ</basicUdiDi>
    <tradeName>STANDARD™ i pre-Trigger</tradeName>
    <deviceName>STANDARD™ i pre-Trigger</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>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16PTR10</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:32:48.229Z</lastUpdated>
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    <udiDi>08800111722684</udiDi>
    <basicUdiDi>88001117IPAA06IA01WV</basicUdiDi>
    <tradeName>STANDARD™ i Trigger</tradeName>
    <deviceName>STANDARD™ i Trigger</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>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16TR10</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:32:47.423Z</lastUpdated>
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    <udiDi>08800111722677</udiDi>
    <basicUdiDi>88001117IPAA07IA01X8</basicUdiDi>
    <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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    <udiDi>08800111722660</udiDi>
    <basicUdiDi>88001117IPAA04IA01W7</basicUdiDi>
    <tradeName>STANDARD™ i Cleanser</tradeName>
    <deviceName>STANDARD™ i Cleanser</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>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>16CL10</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:30:28.897Z</lastUpdated>
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    <udiDi>08800111720260</udiDi>
    <basicUdiDi>88001117IPAA01IA02V8</basicUdiDi>
    <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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    <udiDi>08800069000001</udiDi>
    <basicUdiDi>88000690ABSOLHY</basicUdiDi>
    <tradeName>ABOSOL</tradeName>
    <deviceName>ABSOL</deviceName>
    <manufacturerName>Absology Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000026041</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ABSOL-001</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:27:23.034Z</lastUpdated>
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    <udiDi>08800047500110</udiDi>
    <basicUdiDi>88000475ATPI03GL</basicUdiDi>
    <tradeName>08800047500110</tradeName>
    <deviceName>PCLOK II</deviceName>
    <manufacturerName>PCL Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000029608</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PCLOK II</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:25:12.438Z</lastUpdated>
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    <udiDi>08800037900104</udiDi>
    <basicUdiDi>880003790010AY</basicUdiDi>
    <tradeName>08800037900104</tradeName>
    <deviceName>SimplexTAS 101 Heating Block</deviceName>
    <manufacturerName>tascom co., ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000019000</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020180</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T0001002</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:23:13.036Z</lastUpdated>
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    <basicUdiDi>880003790000AV</basicUdiDi>
    <tradeName>08800037900005</tradeName>
    <deviceName>SimplexTAS 101 Analyzer</deviceName>
    <manufacturerName>tascom co., ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000019000</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020101</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput &lt;= 100 test/h)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T0001001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:23:12.240Z</lastUpdated>
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    <basicUdiDi>86060147198953Z</basicUdiDi>
    <tradeName>Stool extraction system</tradeName>
    <deviceName>Stool extraction system</deviceName>
    <manufacturerName>NEOMEDICA DOO NIŠ</manufacturerName>
    <manufacturerSrn>RS-MF-000021305</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201020185</emdnCode>
    <emdnDescription>AUTOMATED IMMUNOCHEMISTRY ANALYSERS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NU1800S</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-03T14:09:08.021Z</lastUpdated>
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