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    <deviceName>Meril RNA Extraction Kit (Magnetic beads)</deviceName>
    <manufacturerName>Meril Diagnostics Pvt. Ltd.</manufacturerName>
    <manufacturerSrn>IN-MF-000028158</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>MBTREK-01 MBTREK-02</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:17:19.834Z</lastUpdated>
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    <udiDi>08885019711152</udiDi>
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    <tradeName>08885019711152</tradeName>
    <deviceName>abGenix™ Universal Extraction Kit</deviceName>
    <manufacturerName>AITbiotech Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000003510</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <deviceName>abGenix™ Viral DNA and RNA Extraction Kit II (Plate)</deviceName>
    <manufacturerName>AITbiotech Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000003510</manufacturerSrn>
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    <lastUpdated>2026-07-31T21:09:38.262Z</lastUpdated>
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    <udiDi>08885019710964</udiDi>
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    <tradeName>08885019710964</tradeName>
    <deviceName>abGenix™ Bacteria Genomic DNA Extraction Kit (Strip)</deviceName>
    <manufacturerName>AITbiotech Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000003510</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <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>800814</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:09:33.466Z</lastUpdated>
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    <udiDi>08885019710957</udiDi>
    <basicUdiDi>888501971800813X5</basicUdiDi>
    <tradeName>08885019710957</tradeName>
    <deviceName>abGenix™ Bacteria Genomic DNA Extraction Kit (Plate)</deviceName>
    <manufacturerName>AITbiotech Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000003510</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
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    <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>800813</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:09:31.962Z</lastUpdated>
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    <udiDi>08885019710056</udiDi>
    <basicUdiDi>888501971800827XG</basicUdiDi>
    <tradeName>08885019710056</tradeName>
    <deviceName>abGenix™ Tissue Genomic DNA Extraction Kit (Plate)</deviceName>
    <manufacturerName>AITbiotech Pte Ltd</manufacturerName>
    <manufacturerSrn>SG-MF-000003510</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
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    <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>800827</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:09:28.872Z</lastUpdated>
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    <udiDi>08885013958232</udiDi>
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    <tradeName>Sentosa SX Lysis Plate (96)</tradeName>
    <deviceName>Sentosa SX Lysis Plate</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000016088</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300649</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:09:02.199Z</lastUpdated>
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    <udiDi>08885013958201</udiDi>
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    <tradeName>ViroKey HT Virus Total Nucleic Acid Kit (4x96)</tradeName>
    <deviceName>ViroKey Virus Total Nucleic Acid Kit</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301089</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:09:01.422Z</lastUpdated>
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    <udiDi>08885013958126</udiDi>
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    <tradeName>Sentosa SX Virus Total Nucleic Acid Plus II Kit (4x16)</tradeName>
    <deviceName>Sentosa SX Virus Total Nucleic Acid Plus II Kit (4x16)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
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    <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>300351</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:08:59.810Z</lastUpdated>
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    <udiDi>08885013958102</udiDi>
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    <tradeName>Sentosa SX Lysis Beads</tradeName>
    <deviceName>Sentosa SX Lysis Beads</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300291</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:08:57.518Z</lastUpdated>
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    <udiDi>08885013958096</udiDi>
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    <tradeName>Sentosa SX Whole Blood Kit (4x24)</tradeName>
    <deviceName>Sentosa SX Whole Blood Kit (4x24)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300252</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:08:55.001Z</lastUpdated>
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    <udiDi>08885013958072</udiDi>
    <basicUdiDi>888501395SSXVTNAPlus7G</basicUdiDi>
    <tradeName>Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24)</tradeName>
    <deviceName>Sentosa SX Virus Total Nucleic Acid Plus Kit (4x24)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300154</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:08:54.204Z</lastUpdated>
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    <udiDi>08885013958034</udiDi>
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    <tradeName>Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24)</tradeName>
    <deviceName>Sentosa SX Virus Total Nucleic Acid Kit v2.0 (4x24)</deviceName>
    <manufacturerName>Vela Operations Singapore Pte. Ltd.</manufacturerName>
    <manufacturerSrn>SG-MF-000025684</manufacturerSrn>
    <authorisedRepresentativeName>Vela Diagnostics Germany GmbH</authorisedRepresentativeName>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>300042</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T21:08:52.595Z</lastUpdated>
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    <udiDi>06974318130329</udiDi>
    <basicUdiDi>697431813E-KitH4</basicUdiDi>
    <tradeName>Nucleic Acid Extraction Kit T-1728</tradeName>
    <deviceName>Nucleic Acid Extraction Kit</deviceName>
    <manufacturerName>Wuhan MGI Tech Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000018732</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
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    <reference>1000021043</reference>
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    <lastUpdated>2026-07-31T18:35:18.901Z</lastUpdated>
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    <tradeName>Lab-Aid 824 HPV DNA Extraction Kit</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>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>604106</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T17:31:20.087Z</lastUpdated>
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    <tradeName>Nucleic Acid Extraction Reagent</tradeName>
    <deviceName>Nucleic Acid Extraction Reagent</deviceName>
    <manufacturerName>Yaneng BIOscience (Shenzhen) Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000013666</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
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    <lastUpdated>2026-07-31T17:29:30.117Z</lastUpdated>
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    <tradeName>Nucleic Acid Extraction Reagent</tradeName>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
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    <lastUpdated>2026-07-31T17:29:19.340Z</lastUpdated>
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    <tradeName>Nucleic Acid Extraction Reagent</tradeName>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
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    <lastUpdated>2026-07-31T17:28:36.000Z</lastUpdated>
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    <tradeName>Nucleic Acid Extraction Reagent</tradeName>
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    <tradeName>Nucleic Acid Extraction Reagent</tradeName>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
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    <reference>2001FC</reference>
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    <lastUpdated>2026-07-31T17:28:30.384Z</lastUpdated>
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