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    <basicUdiDi>695593130023060001JV</basicUdiDi>
    <tradeName>Automatic Reagent Pipetting System</tradeName>
    <deviceName>Automatic Reagent Pipetting System</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069099</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>230601</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:29:22.887Z</lastUpdated>
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    <udiDi>06955931303116</udiDi>
    <basicUdiDi>695593130023050001JJ</basicUdiDi>
    <tradeName>Automatic Nucleic Acid Extraction System</tradeName>
    <deviceName>Automatic Nucleic Acid Extraction System</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W02069099</emdnCode>
    <emdnDescription>VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>230501</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:29:20.409Z</lastUpdated>
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    <udiDi>06955931303109</udiDi>
    <basicUdiDi>695593130025050001KL</basicUdiDi>
    <tradeName>Sample Pretreatment Kit for DNA Methylation Test</tradeName>
    <deviceName>Sample Pretreatment Kit for DNA Methylation Test</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900103</emdnCode>
    <emdnDescription>SUPPLEMENTAL NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>250501</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:29:14.398Z</lastUpdated>
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    <udiDi>06955931303093</udiDi>
    <basicUdiDi>695593130025050001KL</basicUdiDi>
    <tradeName>Sample Pretreatment Kit for DNA Methylation Test</tradeName>
    <deviceName>Sample Pretreatment Kit for DNA Methylation Test</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900103</emdnCode>
    <emdnDescription>SUPPLEMENTAL NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>250501</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:29:13.229Z</lastUpdated>
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    <udiDi>06955931303086</udiDi>
    <basicUdiDi>B-06955931303086</basicUdiDi>
    <tradeName>DNA Methylation Detection Kit for Human PAX1, SOX1 and HAS1 Gene (Real-Time PCR)</tradeName>
    <deviceName>DNA Methylation Detection Kit for Human PAX1, SOX1 and HAS1 Gene (Real-Time PCR)</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>213301</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:29:12.027Z</lastUpdated>
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    <udiDi>06955931303079</udiDi>
    <basicUdiDi>B-06955931303079</basicUdiDi>
    <tradeName>DNA Methylation Detection Kit for Human PAX1, SOX1 and HAS1 Gene (Real-Time PCR)</tradeName>
    <deviceName>DNA Methylation Detection Kit for Human PAX1, SOX1 and HAS1 Gene (Real-Time PCR)</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>213301</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:29:10.794Z</lastUpdated>
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    <udiDi>06955931303062</udiDi>
    <basicUdiDi>B-06955931303062</basicUdiDi>
    <tradeName>Y Chromosome Microdeletion Detection Kit (PCR-Capillary Electrophoresis)</tradeName>
    <deviceName>Y Chromosome Microdeletion Detection Kit (PCR-Capillary Electrophoresis)</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:29:03.595Z</lastUpdated>
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    <udiDi>06955931303055</udiDi>
    <basicUdiDi>B-06955931303055</basicUdiDi>
    <tradeName>Y Chromosome Microdeletion Detection Kit (PCR-Capillary Electrophoresis)</tradeName>
    <deviceName>Y Chromosome Microdeletion Detection Kit (PCR-Capillary Electrophoresis)</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:29:02.390Z</lastUpdated>
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    <udiDi>06955931303048</udiDi>
    <basicUdiDi>B-06955931303048</basicUdiDi>
    <tradeName>Y Chromosome Microdeletion Detection Kit (PCR-Capillary Electrophoresis)</tradeName>
    <deviceName>Y Chromosome Microdeletion Detection Kit (PCR-Capillary Electrophoresis)</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010399</emdnCode>
    <emdnDescription>CHROMOSOMAL DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:29:01.189Z</lastUpdated>
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    <udiDi>06955931303031</udiDi>
    <basicUdiDi>B-06955931303031</basicUdiDi>
    <tradeName>Spinal Muscular Atrophy Genetic Testing Kit (PCR-Fluorescence Probing)</tradeName>
    <deviceName>Spinal Muscular Atrophy Genetic Testing Kit (PCR-Fluorescence Probing)</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211701</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:29:00.004Z</lastUpdated>
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    <udiDi>06955931303024</udiDi>
    <basicUdiDi>B-06955931303024</basicUdiDi>
    <tradeName>Spinal Muscular Atrophy Genetic Testing Kit（PCR-Fluorescence Probing）</tradeName>
    <deviceName>Spinal Muscular Atrophy Genetic Testing Kit（PCR-Fluorescence Probing）</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211701</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:28:54.001Z</lastUpdated>
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    <udiDi>06955931303017</udiDi>
    <basicUdiDi>B-06955931303017</basicUdiDi>
    <tradeName>Human Papillomavirus Genotyping Kit for 15 Types (PCR-Reverse Dot Blot)</tradeName>
    <deviceName>Human Papillomavirus Genotyping Kit for 15 Types (PCR-Reverse Dot Blot)</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>213501</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:28:52.802Z</lastUpdated>
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    <udiDi>06955931303000</udiDi>
    <basicUdiDi>B-06955931303000</basicUdiDi>
    <tradeName>Human Papillomavirus Genotyping Kit for 15 Types (PCR-Reverse Dot Blot)</tradeName>
    <deviceName>Human Papillomavirus Genotyping Kit for 15 Types (PCR-Reverse Dot Blot)</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>213501</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:28:51.599Z</lastUpdated>
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    <udiDi>06955931302997</udiDi>
    <basicUdiDi>B-06955931302997</basicUdiDi>
    <tradeName>Human Papillomavirus Genotyping Kit for 15 Types  (PCR-Reverse Dot Blot)</tradeName>
    <deviceName>Human Papillomavirus Genotyping Kit for 15 Types  (PCR-Reverse Dot Blot)</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>213501</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:28:50.385Z</lastUpdated>
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    <udiDi>06955931302980</udiDi>
    <basicUdiDi>B-06955931302980</basicUdiDi>
    <tradeName>Human Papillomavirus Genotyping Kit for 15 Types  (PCR-Reverse Dot Blot)</tradeName>
    <deviceName>Human Papillomavirus Genotyping Kit for 15 Types  (PCR-Reverse Dot Blot)</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041003</emdnCode>
    <emdnDescription>PARTIAL GENOTYPING HIGH-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>213501</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:28:43.182Z</lastUpdated>
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    <udiDi>06955931302973</udiDi>
    <basicUdiDi>B-06955931302973</basicUdiDi>
    <tradeName>Human Papillomavirus Genotyping Kit for 23 Types (PCR-Reverse Dot Blot)</tradeName>
    <deviceName>Human Papillomavirus Genotyping Kit for 23 Types (PCR-Reverse Dot Blot)</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041004</emdnCode>
    <emdnDescription>FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>210601</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:28:41.981Z</lastUpdated>
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    <udiDi>06955931302966</udiDi>
    <basicUdiDi>B-06955931302966</basicUdiDi>
    <tradeName>Human Papillomavirus Genotyping Kit for 23 Types (PCR-Reverse Dot Blot)</tradeName>
    <deviceName>Human Papillomavirus Genotyping Kit for 23 Types (PCR-Reverse Dot Blot)</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041004</emdnCode>
    <emdnDescription>FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>210601</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:28:40.781Z</lastUpdated>
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    <udiDi>06955931302959</udiDi>
    <basicUdiDi>B-06955931302959</basicUdiDi>
    <tradeName>Human Papillomavirus Genotyping Kit for 23 Types (PCR-Reverse Dot Blot)</tradeName>
    <deviceName>Human Papillomavirus Genotyping Kit for 23 Types (PCR-Reverse Dot Blot)</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041004</emdnCode>
    <emdnDescription>FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>210601</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:28:39.589Z</lastUpdated>
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    <udiDi>06955931302904</udiDi>
    <basicUdiDi>B-06955931302904</basicUdiDi>
    <tradeName>Human Papillomavirus Genotyping Kit (Multicolor Melting Curve Analysis)</tradeName>
    <deviceName>Human Papillomavirus Genotyping Kit (Multicolor Melting Curve Analysis)</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041005</emdnCode>
    <emdnDescription>OTHER HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>212901</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:28:33.571Z</lastUpdated>
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    <udiDi>06955931302898</udiDi>
    <basicUdiDi>B-06955931302898</basicUdiDi>
    <tradeName>Human Papillomavirus Genotyping Kit (Multicolor Melting Curve Analysis)</tradeName>
    <deviceName>Human Papillomavirus Genotyping Kit (Multicolor Melting Curve Analysis)</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041005</emdnCode>
    <emdnDescription>OTHER HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>212901</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:28:32.373Z</lastUpdated>
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