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    <basicUdiDi>B-06955931305035</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>2026-06-28T18:32:45.724Z</lastUpdated>
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    <udiDi>06955931305028</udiDi>
    <basicUdiDi>B-06955931305028</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>2026-06-28T18:32:44.531Z</lastUpdated>
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    <udiDi>06955931305011</udiDi>
    <basicUdiDi>B-06955931305011</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>2026-06-28T18:32:38.517Z</lastUpdated>
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    <udiDi>06955931305004</udiDi>
    <basicUdiDi>B-06955931305004</basicUdiDi>
    <tradeName>Non-deletion Alpha Thalassemia Gene Assay Kit (Multicolor Melting Curve Analysis)</tradeName>
    <deviceName>Non-deletion Alpha 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>212301</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:32:37.775Z</lastUpdated>
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    <udiDi>06955931304991</udiDi>
    <basicUdiDi>B-06955931304991</basicUdiDi>
    <tradeName>Non-deletion Alpha Thalassemia Gene Assay Kit (Multicolor Melting Curve Analysis)</tradeName>
    <deviceName>Non-deletion Alpha 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>212301</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:32:36.115Z</lastUpdated>
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    <udiDi>06955931304984</udiDi>
    <basicUdiDi>B-06955931304984</basicUdiDi>
    <tradeName>Deletion Alpha Thalassemia Gene Assay Kit (Multicolor Melting Curve Analysis)</tradeName>
    <deviceName>Deletion Alpha 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>212201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:32:34.920Z</lastUpdated>
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    <udiDi>06955931304977</udiDi>
    <basicUdiDi>B-06955931304977</basicUdiDi>
    <tradeName>Deletion Alpha Thalassemia Gene Assay Kit (Multicolor Melting Curve Analysis)</tradeName>
    <deviceName>Deletion Alpha 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>212201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:32:28.935Z</lastUpdated>
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    <udiDi>06955931304960</udiDi>
    <basicUdiDi>B-06955931304960</basicUdiDi>
    <tradeName>Thalassemia Genotyping Kit (PCR-Reverse Dot Blot)</tradeName>
    <deviceName>Thalassemia Genotyping Kit (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>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>210325</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:32:27.715Z</lastUpdated>
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    <udiDi>06955931304953</udiDi>
    <basicUdiDi>B-06955931304953</basicUdiDi>
    <tradeName>Thalassemia Genotyping Kit (PCR-Reverse Dot Blot)</tradeName>
    <deviceName>Thalassemia Genotyping Kit (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>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>210325</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:32:26.524Z</lastUpdated>
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    <udiDi>06955931304946</udiDi>
    <basicUdiDi>B-06955931304946</basicUdiDi>
    <tradeName>Thalassemia Genotyping Kit (PCR-Reverse Dot Blot)</tradeName>
    <deviceName>Thalassemia Genotyping Kit (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>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>210325</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:32:25.332Z</lastUpdated>
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    <udiDi>06955931304939</udiDi>
    <basicUdiDi>B-06955931304939</basicUdiDi>
    <tradeName>Beta Thalassemia Genotyping kit (PCR-Reverse Dot Blot)</tradeName>
    <deviceName>Beta Thalassemia Genotyping kit (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>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:32:19.309Z</lastUpdated>
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    <udiDi>06955931304922</udiDi>
    <basicUdiDi>B-06955931304922</basicUdiDi>
    <tradeName>Beta Thalassemia Genotyping kit (PCR-Reverse Dot Blot)</tradeName>
    <deviceName>Beta Thalassemia Genotyping kit (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>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:32:18.110Z</lastUpdated>
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    <udiDi>06955931304915</udiDi>
    <basicUdiDi>B-06955931304915</basicUdiDi>
    <tradeName>Beta Thalassemia Genotyping kit (PCR-Reverse Dot Blot)</tradeName>
    <deviceName>Beta Thalassemia Genotyping kit (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>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211201</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:32:16.958Z</lastUpdated>
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    <udiDi>06955931304908</udiDi>
    <basicUdiDi>B-06955931304908</basicUdiDi>
    <tradeName>Nondeletion Alpha Thalassemia Genotyping Kit (PCR-Reverse Dot Blot)</tradeName>
    <deviceName>Nondeletion Alpha Thalassemia Genotyping Kit (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>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:32:15.712Z</lastUpdated>
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    <udiDi>06955931304892</udiDi>
    <basicUdiDi>B-06955931304892</basicUdiDi>
    <tradeName>Nondeletion Alpha Thalassemia Genotyping Kit (PCR-Reverse Dot Blot)</tradeName>
    <deviceName>Nondeletion Alpha Thalassemia Genotyping Kit (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>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:32:08.510Z</lastUpdated>
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    <udiDi>06955931304885</udiDi>
    <basicUdiDi>B-06955931304885</basicUdiDi>
    <tradeName>Nondeletion Alpha Thalassemia Genotyping Kit (PCR-Reverse Dot Blot)</tradeName>
    <deviceName>Nondeletion Alpha Thalassemia Genotyping Kit (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>W0106010111</emdnCode>
    <emdnDescription>THALASSAEMIA</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>211001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:32:07.312Z</lastUpdated>
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    <udiDi>06955931304878</udiDi>
    <basicUdiDi>B-06955931304878</basicUdiDi>
    <tradeName>Alpha Thalassemia Genotyping Kit (gap-PCR)</tradeName>
    <deviceName>Alpha Thalassemia Genotyping 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>210425</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:32:06.115Z</lastUpdated>
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    <udiDi>06955931304861</udiDi>
    <basicUdiDi>695593130025070001LA</basicUdiDi>
    <tradeName>Newborn Blood Spot Collection Card</tradeName>
    <deviceName>Newborn Blood Spot Collection Card</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>W0501010299</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>250701</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:32:04.907Z</lastUpdated>
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    <udiDi>06955931304854</udiDi>
    <basicUdiDi>695593130025070001LA</basicUdiDi>
    <tradeName>Newborn Blood Spot Collection Card</tradeName>
    <deviceName>Newborn Blood Spot Collection Card</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>W0501010299</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>250701</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:31:58.906Z</lastUpdated>
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    <udiDi>06955931304847</udiDi>
    <basicUdiDi>695593130025070001LA</basicUdiDi>
    <tradeName>Newborn Blood Spot Collection Card</tradeName>
    <deviceName>Newborn Blood Spot Collection Card</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>W0501010299</emdnCode>
    <emdnDescription>CAPILLARY BLOOD COLLECTION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>250701</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-06-28T18:31:57.711Z</lastUpdated>
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