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    <udiDi>06955931305271</udiDi>
    <basicUdiDi>B-06955931305271</basicUdiDi>
    <tradeName>Human Papillomavirus Genotyping Kit for 18 Types (PCR-Reverse Dot Blot)</tradeName>
    <deviceName>Human Papillomavirus Genotyping Kit for 18 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>212501</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:33:33.771Z</lastUpdated>
  </row>
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    <udiDi>06955931305264</udiDi>
    <basicUdiDi>B-06955931305264</basicUdiDi>
    <tradeName>Human Papillomavirus Genotyping Kit for 18 Types (PCR-Reverse Dot Blot)</tradeName>
    <deviceName>Human Papillomavirus Genotyping Kit for 18 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>212501</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:33:32.575Z</lastUpdated>
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    <udiDi>06955931305257</udiDi>
    <basicUdiDi>B-06955931305257</basicUdiDi>
    <tradeName>Human Papillomavirus Genotyping Kit for 18 Types (PCR-Reverse Dot Blot)</tradeName>
    <deviceName>Human Papillomavirus Genotyping Kit for 18 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>212501</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:33:26.574Z</lastUpdated>
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    <udiDi>06955931305240</udiDi>
    <basicUdiDi>B-06955931305240</basicUdiDi>
    <tradeName>Group B Streptococcus Nucleic Acid Detection Kit  (Real-Time PCR)</tradeName>
    <deviceName>Group B Streptococcus Nucleic Acid Detection Kit  (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>W0105011104</emdnCode>
    <emdnDescription>STREP. B DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>213601</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:33:25.356Z</lastUpdated>
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    <udiDi>06955931305233</udiDi>
    <basicUdiDi>B-06955931305233</basicUdiDi>
    <tradeName>Group B Streptococcus Nucleic Acid Detection Kit  (Real-Time PCR)</tradeName>
    <deviceName>Group B Streptococcus Nucleic Acid Detection Kit  (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>W0105011104</emdnCode>
    <emdnDescription>STREP. B DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>213601</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:33:24.155Z</lastUpdated>
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    <udiDi>06955931305226</udiDi>
    <basicUdiDi>B-06955931305226</basicUdiDi>
    <tradeName>Group B Streptococcus Nucleic Acid Detection Kit  (Real-Time PCR)</tradeName>
    <deviceName>Group B Streptococcus Nucleic Acid Detection Kit  (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>W0105011104</emdnCode>
    <emdnDescription>STREP. B DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>213601</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:33:22.965Z</lastUpdated>
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    <udiDi>06955931305219</udiDi>
    <basicUdiDi>B-06955931305219</basicUdiDi>
    <tradeName>DNA Methylation Detection Kit for Human SDC2, SEPTIN9 and TFPI2 Gene (Real-Time PCR)</tradeName>
    <deviceName>DNA Methylation Detection Kit for Human SDC2, SEPTIN9 and TFPI2 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>W01060214</emdnCode>
    <emdnDescription>COLORECTAL CANCER (MSI-H / DMMR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>213201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:33:16.958Z</lastUpdated>
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    <udiDi>06955931305202</udiDi>
    <basicUdiDi>B-06955931305202</basicUdiDi>
    <tradeName>DNA Methylation Detection Kit for Human SDC2, SEPTIN9 and TFPI2 Gene (Real-Time PCR)</tradeName>
    <deviceName>DNA Methylation Detection Kit for Human SDC2, SEPTIN9 and TFPI2 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>W01060214</emdnCode>
    <emdnDescription>COLORECTAL CANCER (MSI-H / DMMR)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>213201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:33:15.754Z</lastUpdated>
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  <row>
    <udiDi>06955931305196</udiDi>
    <basicUdiDi>B-06955931305196</basicUdiDi>
    <tradeName>DNA Methylation Detection Kit for Human PCDH17, POU4F2 and PENK Gene (Real-Time PCR)</tradeName>
    <deviceName>DNA Methylation Detection Kit for Human PCDH17, POU4F2 and PENK 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>W01060215</emdnCode>
    <emdnDescription>BLADDER CANCER DETECTION / MONITORING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>213101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:33:14.553Z</lastUpdated>
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  <row>
    <udiDi>06955931305189</udiDi>
    <basicUdiDi>B-06955931305189</basicUdiDi>
    <tradeName>DNA Methylation Detection Kit for Human PCDH17, POU4F2 and PENK Gene (Real-Time PCR)</tradeName>
    <deviceName>DNA Methylation Detection Kit for Human PCDH17, POU4F2 and PENK 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>W01060215</emdnCode>
    <emdnDescription>BLADDER CANCER DETECTION / MONITORING</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>213101</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:33:13.360Z</lastUpdated>
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  <row>
    <udiDi>06955931305172</udiDi>
    <basicUdiDi>B-06955931305172</basicUdiDi>
    <tradeName>Genetic Deafness Gene Testing Kit (Multicolor Melting Curve Analysis)</tradeName>
    <deviceName>Genetic Deafness Gene Testing 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>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>213401</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:33:07.340Z</lastUpdated>
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  <row>
    <udiDi>06955931305165</udiDi>
    <basicUdiDi>B-06955931305165</basicUdiDi>
    <tradeName>Genetic Deafness Gene Testing Kit (Multicolor Melting Curve Analysis)</tradeName>
    <deviceName>Genetic Deafness Gene Testing 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>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>213401</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:33:06.148Z</lastUpdated>
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  <row>
    <udiDi>06955931305158</udiDi>
    <basicUdiDi>B-06955931305158</basicUdiDi>
    <tradeName>Beta Thalassemia Genotyping kit (Multicolor Melting Curve Analysis)</tradeName>
    <deviceName>Beta Thalassemia 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>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>213001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:33:04.957Z</lastUpdated>
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  <row>
    <udiDi>06955931305141</udiDi>
    <basicUdiDi>B-06955931305141</basicUdiDi>
    <tradeName>Beta Thalassemia Gene Assay Kit (Multicolor Melting Curve Analysis)</tradeName>
    <deviceName>Beta Thalassemia Gene Assay 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>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>213001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:33:03.737Z</lastUpdated>
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  <row>
    <udiDi>06955931305097</udiDi>
    <basicUdiDi>B-06955931305097</basicUdiDi>
    <tradeName>Deletion Alpha Thalassemia Gene Assay Kit (Gap-PCR)</tradeName>
    <deviceName>Deletion Alpha Thalassemia Gene Assay Kit (Gap-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>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>212701</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:32:57.751Z</lastUpdated>
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    <udiDi>06955931305080</udiDi>
    <basicUdiDi>B-06955931305080</basicUdiDi>
    <tradeName>Deletion Alpha Thalassemia Gene Assay Kit (Gap-PCR)</tradeName>
    <deviceName>Deletion Alpha Thalassemia Gene Assay Kit (Gap-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>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>212701</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:32:56.540Z</lastUpdated>
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  <row>
    <udiDi>06955931305073</udiDi>
    <basicUdiDi>B-06955931305073</basicUdiDi>
    <tradeName>Deletion Alpha Thalassemia Gene Assay Kit (Gap-PCR)</tradeName>
    <deviceName>Deletion Alpha Thalassemia Gene Assay Kit (Gap-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>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>212701</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:32:55.332Z</lastUpdated>
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    <udiDi>06955931305066</udiDi>
    <basicUdiDi>B-06955931305066</basicUdiDi>
    <tradeName>Respiratory Pathogens Combo Testing Kit</tradeName>
    <deviceName>Respiratory Pathogens Combo Testing Kit</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>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>212801</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:32:54.134Z</lastUpdated>
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  <row>
    <udiDi>06955931305059</udiDi>
    <basicUdiDi>B-06955931305059</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>212601</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:32:48.127Z</lastUpdated>
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  <row>
    <udiDi>06955931305042</udiDi>
    <basicUdiDi>B-06955931305042</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>212601</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:32:46.926Z</lastUpdated>
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