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    <basicUdiDi>++ENTIWE20002V036A</basicUdiDi>
    <tradeName>Substrat/Substrate LINE</tradeName>
    <deviceName>Substrat/Substrate LINE</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WE200.02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:23.628Z</lastUpdated>
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    <udiDi>+ENTIWE4004209</udiDi>
    <basicUdiDi>++ENTIWE400X2V02LT</basicUdiDi>
    <tradeName>IgA Konjugat/Conjugate (anti-human) LINE</tradeName>
    <deviceName>IgG Konjugat/Conjugate (anti-human) LINE</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WE400.42</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:23.502Z</lastUpdated>
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    <udiDi>+ENTIW00000S</udiDi>
    <basicUdiDi>++ENTIW0000V018B</basicUdiDi>
    <tradeName>Washing Buffer (20x concentrated)</tradeName>
    <deviceName>Washing Buffer (20x concentrated)</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W0000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:05.182Z</lastUpdated>
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    <udiDi>+ENTI16110106</udiDi>
    <basicUdiDi>++ENTI16110XV02YC</basicUdiDi>
    <tradeName>RF-SorboTech</tradeName>
    <deviceName>RF-SorboTech</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>161101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:04.376Z</lastUpdated>
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  <row>
    <udiDi>+ENTI15110105</udiDi>
    <basicUdiDi>++ENTI151101V03PH</basicUdiDi>
    <tradeName>TMB-Substrat/Substrate ELISA</tradeName>
    <deviceName>TMB-Substrat/Substrate ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>151101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:03.572Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTI14130106</udiDi>
    <basicUdiDi>++ENTI141X01V036F</basicUdiDi>
    <tradeName>PBS-Verdünnungspuffer/Dilution Buffer ELISA</tradeName>
    <deviceName>PBS-Verdünnungspuffer/Dilution Buffer ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>141301</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:02.771Z</lastUpdated>
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  <row>
    <udiDi>+ENTI14120105</udiDi>
    <basicUdiDi>++ENTI141201V02P9</basicUdiDi>
    <tradeName>PBS-Waschlösung/Washing Solution ELISA</tradeName>
    <deviceName>PBS-Waschlösung/Washing Solution ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>141201</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:08:58.763Z</lastUpdated>
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  <row>
    <udiDi>+ENTI14110104</udiDi>
    <basicUdiDi>++ENTI141101V03NW</basicUdiDi>
    <tradeName>Citrat Stopplösung/Stopping Solution ELISA</tradeName>
    <deviceName>Citrat Stopplösung/Stopping Solution ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>141101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:08:57.966Z</lastUpdated>
  </row>
  <row>
    <udiDi>+ENTI13110103</udiDi>
    <basicUdiDi>++ENTI131X01V025S</basicUdiDi>
    <tradeName>IgG Konjugat/Conjugate (anti-human) ELISA</tradeName>
    <deviceName>IgA Konjugat/Conjugate (anti-human) ELISA</deviceName>
    <manufacturerName>Gold Standard Diagnostics Frankfurt GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000025020</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105900201</emdnCode>
    <emdnDescription>BUFFERS (UNASSIGNABLE ), SUPPLEM. REAGENTS, ETC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>131101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:08:57.172Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <row>
    <udiDi>D-U-200-0243S</udiDi>
    <basicUdiDi>B-U-200-0243S</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>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>U-200-024</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:25:48.594Z</lastUpdated>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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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  <row>
    <udiDi>D-U-050-04857</udiDi>
    <basicUdiDi>B-U-050-04857</basicUdiDi>
    <tradeName>UMD-SelectNA™ CE IVD</tradeName>
    <deviceName>UMD-SelectNA™ 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>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>U-050-048</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:25:41.162Z</lastUpdated>
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  <row>
    <udiDi>D-U-050-0244R</udiDi>
    <basicUdiDi>B-U-050-0244R</basicUdiDi>
    <tradeName>UMD-SelectNA™ CE IVD</tradeName>
    <deviceName>UMD-SelectNA™ 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>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>U-050-024</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:25:39.833Z</lastUpdated>
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  <row>
    <udiDi>D-U-010-0483K</udiDi>
    <basicUdiDi>B-U-010-0483K</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>W0105900102</emdnCode>
    <emdnDescription>REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>U-010-048</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T08:25:38.766Z</lastUpdated>
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  <row>
    <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>
    <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-103-A/8EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:54:53.359Z</lastUpdated>
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