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    <basicUdiDi>B-06956299703198</basicUdiDi>
    <tradeName>Leukemia Fusion Genes (Q51) Screening Kit</tradeName>
    <deviceName>Leukemia Fusion Genes (Q51) Screening Kit</deviceName>
    <manufacturerName>Xiamen Zeesan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>803100</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:48:01.944Z</lastUpdated>
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    <udiDi>06956299703099</udiDi>
    <basicUdiDi>695629970004P5</basicUdiDi>
    <tradeName>FFPE DNA Extraction Kit (Model: Lab-Aid 824s)</tradeName>
    <deviceName>Nucleic Acid Extraction Kit</deviceName>
    <manufacturerName>Xiamen Zeesan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>606904</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:48:00.842Z</lastUpdated>
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    <udiDi>06956299703075</udiDi>
    <basicUdiDi>B-06956299703075</basicUdiDi>
    <tradeName>PML-RARα Genotyping Kit</tradeName>
    <deviceName>PML-RARα Genotyping Kit</deviceName>
    <manufacturerName>Xiamen Zeesan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>803216</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:47:52.343Z</lastUpdated>
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    <udiDi>06956299703068</udiDi>
    <basicUdiDi>B-06956299703068</basicUdiDi>
    <tradeName>BCR-ABL1 Genotyping Kit</tradeName>
    <deviceName>BCR-ABL1 Genotyping Kit</deviceName>
    <manufacturerName>Xiamen Zeesan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>803215</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:47:51.132Z</lastUpdated>
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    <udiDi>06956299703051</udiDi>
    <basicUdiDi>B-06956299703051</basicUdiDi>
    <tradeName>PML-RARα V Detection Kit</tradeName>
    <deviceName>PML-RARα V Detection Kit</deviceName>
    <manufacturerName>Xiamen Zeesan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>803214</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:47:49.933Z</lastUpdated>
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  <row>
    <udiDi>06956299703044</udiDi>
    <basicUdiDi>B-06956299703044</basicUdiDi>
    <tradeName>PML-RARα S Detection Kit</tradeName>
    <deviceName>PML-RARα S Detection Kit</deviceName>
    <manufacturerName>Xiamen Zeesan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>803213</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:47:48.734Z</lastUpdated>
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  <row>
    <udiDi>06956299703037</udiDi>
    <basicUdiDi>B-06956299703037</basicUdiDi>
    <tradeName>PML-RARα L Detection Kit</tradeName>
    <deviceName>PML-RARα L Detection Kit</deviceName>
    <manufacturerName>Xiamen Zeesan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>803212</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:47:42.831Z</lastUpdated>
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    <udiDi>06956299703020</udiDi>
    <basicUdiDi>B-06956299703020</basicUdiDi>
    <tradeName>AML1-ETO Detection Kit</tradeName>
    <deviceName>AML1-ETO Detection Kit</deviceName>
    <manufacturerName>Xiamen Zeesan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>803209</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:47:40.332Z</lastUpdated>
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  <row>
    <udiDi>06956299703013</udiDi>
    <basicUdiDi>B-06956299703013</basicUdiDi>
    <tradeName>Leukemia Fusion Genes (Q30) Screening Kit</tradeName>
    <deviceName>Leukemia Fusion Genes (Q30) Screening Kit</deviceName>
    <manufacturerName>Xiamen Zeesan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01060299</emdnCode>
    <emdnDescription>TESTS FOR ACQUIRED GENETIC OR CHROMOSOMAL ALTERATIONS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>803041</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:47:39.131Z</lastUpdated>
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    <udiDi>06956299702979</udiDi>
    <basicUdiDi>B-06956299702979</basicUdiDi>
    <tradeName>MTB Test Kit</tradeName>
    <deviceName>MTB Test Kit</deviceName>
    <manufacturerName>Xiamen Zeesan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>801219</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:47:37.935Z</lastUpdated>
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    <udiDi>06956299702962</udiDi>
    <basicUdiDi>B-06956299702962</basicUdiDi>
    <tradeName>MTB/PZA Test Kit</tradeName>
    <deviceName>MTB/PZA Test Kit</deviceName>
    <manufacturerName>Xiamen Zeesan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>801218</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:47:31.930Z</lastUpdated>
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    <udiDi>06956299702955</udiDi>
    <basicUdiDi>B-06956299702955</basicUdiDi>
    <tradeName>MTB/STR Test Kit (MMCA)</tradeName>
    <deviceName>MTB/STR Test Kit (MMCA)</deviceName>
    <manufacturerName>Xiamen Zeesan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>801217</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:47:30.741Z</lastUpdated>
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    <udiDi>06956299702948</udiDi>
    <basicUdiDi>B-06956299702948</basicUdiDi>
    <tradeName>MTB/EMB Test Kit (MMCA)</tradeName>
    <deviceName>MTB/EMB Test Kit (MMCA)</deviceName>
    <manufacturerName>Xiamen Zeesan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>801216</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:47:29.539Z</lastUpdated>
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    <udiDi>06956299702917</udiDi>
    <basicUdiDi>B-06956299702917</basicUdiDi>
    <tradeName>MDR-TB Test Kit (MMCA)</tradeName>
    <deviceName>MDR-TB Test Kit (MMCA)</deviceName>
    <manufacturerName>Xiamen Zeesan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>801213</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:47:28.336Z</lastUpdated>
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    <udiDi>06956299702900</udiDi>
    <basicUdiDi>B-06956299702900</basicUdiDi>
    <tradeName>Mycobacteria Identification Kit (MMCA)</tradeName>
    <deviceName>Mycobacteria Identification Kit (MMCA)</deviceName>
    <manufacturerName>Xiamen Zeesan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>801210</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:47:22.337Z</lastUpdated>
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    <udiDi>06956299702894</udiDi>
    <basicUdiDi>B-06956299702894</basicUdiDi>
    <tradeName>MTB/SL Test Kit (MMCA)</tradeName>
    <deviceName>MTB/SL Test Kit (MMCA)</deviceName>
    <manufacturerName>Xiamen Zeesan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>801206</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:47:21.120Z</lastUpdated>
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    <udiDi>06956299702887</udiDi>
    <basicUdiDi>B-06956299702887</basicUdiDi>
    <tradeName>MTB/FQ Test Kit (MMCA)</tradeName>
    <deviceName>MTB/FQ Test Kit (MMCA)</deviceName>
    <manufacturerName>Xiamen Zeesan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>801205</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:47:19.921Z</lastUpdated>
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    <udiDi>06956299702870</udiDi>
    <basicUdiDi>B-06956299702870</basicUdiDi>
    <tradeName>MTB/MDR Test Kit (Sanity 2.0)</tradeName>
    <deviceName>MTB/MDR Test Kit (Sanity 2.0)</deviceName>
    <manufacturerName>Xiamen Zeesan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>801181</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:47:18.740Z</lastUpdated>
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    <udiDi>06956299702863</udiDi>
    <basicUdiDi>B-06956299702863</basicUdiDi>
    <tradeName>Mycobacteria Identification Kit (Sanity 2.0)</tradeName>
    <deviceName>Mycobacteria Identification Kit (Sanity 2.0)</deviceName>
    <manufacturerName>Xiamen Zeesan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>801180</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:47:12.735Z</lastUpdated>
  </row>
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    <udiDi>06956299702856</udiDi>
    <basicUdiDi>B-06956299702856</basicUdiDi>
    <tradeName>MDR-TB Test Kit (Sanity 2.0)</tradeName>
    <deviceName>MDR-TB Test Kit (Sanity 2.0)</deviceName>
    <manufacturerName>Xiamen Zeesan Biotech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013246</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>801177</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T20:47:11.531Z</lastUpdated>
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