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    <basicUdiDi>++G226FFPEDNAPKit95</basicUdiDi>
    <tradeName>++G226DX474000%</tradeName>
    <deviceName>FFPE DNA Purification Kit Dx</deviceName>
    <manufacturerName>Norgen Biotek Corporation</manufacturerName>
    <manufacturerSrn>CA-MF-000024034</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>Dx47400</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:11:41.512Z</lastUpdated>
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    <udiDi>++G226DX463000/</udiDi>
    <basicUdiDi>++G226BloodgDNAIKitPU</basicUdiDi>
    <tradeName>++G226DX463000/</tradeName>
    <deviceName>Blood Genomic DNA Isolation Mini Kit Dx</deviceName>
    <manufacturerName>Norgen Biotek Corporation</manufacturerName>
    <manufacturerSrn>CA-MF-000024034</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Dx46300</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
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    <udiDi>++G226DX454000/</udiDi>
    <basicUdiDi>++G226SalivaDNAIKit22</basicUdiDi>
    <tradeName>++G226DX454000/</tradeName>
    <deviceName>Saliva DNA Isolation Kit Dx</deviceName>
    <manufacturerName>Norgen Biotek Corporation</manufacturerName>
    <manufacturerSrn>CA-MF-000024034</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <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>Dx45400</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:11:41.417Z</lastUpdated>
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    <udiDi>++G226DX253000.</udiDi>
    <basicUdiDi>++G226FFPERNAPKitGK</basicUdiDi>
    <tradeName>++G226DX253000.</tradeName>
    <deviceName>FFPE RNA Purification Kit Dx</deviceName>
    <manufacturerName>Norgen Biotek Corporation</manufacturerName>
    <manufacturerSrn>CA-MF-000024034</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>Dx25300</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:11:33.521Z</lastUpdated>
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    <udiDi>++G226DX172000.</udiDi>
    <basicUdiDi>++G226TotalRNAPKitT5</basicUdiDi>
    <tradeName>++G226DX172000.</tradeName>
    <deviceName>Total RNA Purification Kit Dx</deviceName>
    <manufacturerName>Norgen Biotek Corporation</manufacturerName>
    <manufacturerSrn>CA-MF-000024034</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>Dx17200</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:11:32.725Z</lastUpdated>
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    <udiDi>++G226DX428000+</udiDi>
    <basicUdiDi>++G226PlaSercfexRNAPKitCC</basicUdiDi>
    <tradeName>++G226DX428000+</tradeName>
    <deviceName>Plasma/Serum Circulating and Exosomal RNA Purification Kit Dx (Slurry Format)</deviceName>
    <manufacturerName>Norgen Biotek Corporation</manufacturerName>
    <manufacturerSrn>CA-MF-000024034</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>Dx42800</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:11:31.927Z</lastUpdated>
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    <udiDi>++G226DX276000%</udiDi>
    <basicUdiDi>++G226StoolDNAIKitTD</basicUdiDi>
    <tradeName>++G226DX276000%</tradeName>
    <deviceName>Stool DNA Isolation Kit Dx</deviceName>
    <manufacturerName>Norgen Biotek Corporation</manufacturerName>
    <manufacturerSrn>CA-MF-000024034</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</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>Dx27600</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:11:31.128Z</lastUpdated>
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    <udiDi>D-U-200-04848</udiDi>
    <basicUdiDi>B-U-200-04848</basicUdiDi>
    <tradeName>Micro-Dx™ CE IVD</tradeName>
    <deviceName>Micro-Dx™ CE IVD</deviceName>
    <manufacturerName>Molzym GmbH &amp; Co.KG</manufacturerName>
    <manufacturerSrn>DE-MF-000037419</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>U-200-048</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:25:48.615Z</lastUpdated>
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    <udiDi>D-U-120-0484H</udiDi>
    <basicUdiDi>B-U-120-0484H</basicUdiDi>
    <tradeName>Add-On 10 CE IVD</tradeName>
    <deviceName>Add-On 10 CE IVD</deviceName>
    <manufacturerName>Molzym GmbH &amp; Co.KG</manufacturerName>
    <manufacturerSrn>DE-MF-000037419</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>U-120-048</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:25:48.521Z</lastUpdated>
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    <udiDi>D-U-120-02443</udiDi>
    <basicUdiDi>B-U-120-02443</basicUdiDi>
    <tradeName>Add-On 10 CE IVD</tradeName>
    <deviceName>Add-On 10 CE IVD</deviceName>
    <manufacturerName>Molzym GmbH &amp; Co.KG</manufacturerName>
    <manufacturerSrn>DE-MF-000037419</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>U-120-024</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:25:45.497Z</lastUpdated>
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    <udiDi>D-U-010-02435</udiDi>
    <basicUdiDi>B-U-010-02435</basicUdiDi>
    <tradeName>SepsiTest™-UMD CE IVD</tradeName>
    <deviceName>SepsiTest™-UMD CE IVD</deviceName>
    <manufacturerName>Molzym GmbH &amp; Co.KG</manufacturerName>
    <manufacturerSrn>DE-MF-000037419</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105900101</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>U-010-024</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:25:37.165Z</lastUpdated>
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    <udiDi>04660014363025</udiDi>
    <basicUdiDi>466001436RA072XB</basicUdiDi>
    <tradeName>PREP-MB DWP DNA/RNA Extraction Kit, Package P Set No. 2</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
    <manufacturerSrn>RU-MF-000028223</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>Р-120-P/9EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:54:58.375Z</lastUpdated>
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    <udiDi>04660014363032</udiDi>
    <basicUdiDi>466001436RA072XB</basicUdiDi>
    <tradeName>PREP-MB DWP DNA/RNA Extraction Kit, Package P Set No. 3</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
    <manufacturerSrn>RU-MF-000028223</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</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>Р-121-P/9EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:54:57.868Z</lastUpdated>
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    <udiDi>04660014363056</udiDi>
    <basicUdiDi>466001436RA070X7</basicUdiDi>
    <tradeName>PREP-MB MAX DNA Extraction Kit, Package A</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
    <manufacturerSrn>RU-MF-000028223</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</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>Р-103-A/8EU</reference>
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    <lastUpdated>2026-07-14T19:54:53.359Z</lastUpdated>
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    <udiDi>04660014364824</udiDi>
    <basicUdiDi>466001436RA079XR</basicUdiDi>
    <tradeName>PREP-MB-RAPID II DNA Extraction Kit, Package N</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
    <manufacturerSrn>RU-MF-000028223</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>Р-122-N/9EU</reference>
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    <udiDi>04660014364831</udiDi>
    <basicUdiDi>466001436RA079XR</basicUdiDi>
    <tradeName>PREP-MB-RAPID II DNA Extraction Kit, Package P Set No. 1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
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    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
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    <tradeName>PREP-MB-RAPID II DNA Extraction Kit, Package P Set No. 2</tradeName>
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    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
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    <udiDi>04660014364756</udiDi>
    <basicUdiDi>466001436RA041WY</basicUdiDi>
    <tradeName>PREP-NA PLUS DNA/RNA Extraction Kit, Package N Set No. 1</tradeName>
    <deviceName></deviceName>
    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P-036-N/1EU</reference>
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    <basicUdiDi>466001436RA041WY</basicUdiDi>
    <tradeName>PREP-NA PLUS DNA/RNA Extraction Kit, Package N Set No. 2</tradeName>
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    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
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    <udiDi>04660014363087</udiDi>
    <basicUdiDi>466001436RA060X4</basicUdiDi>
    <tradeName>PREP-OPTIMA DNA Extraction Kit. Package N</tradeName>
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    <manufacturerName>DNA-Technology, Research &amp; Production, LLC</manufacturerName>
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    <reference>P-016-N/2EU</reference>
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