<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>
  </row>
  <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>
  </row>
  <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>
  </row>
  <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>
  </row>
  <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
    <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-122-N/9EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:54:44.586Z</lastUpdated>
  </row>
  <row>
    <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>
    <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-122-P/9EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:53:32.465Z</lastUpdated>
  </row>
  <row>
    <udiDi>04660014364862</udiDi>
    <basicUdiDi>466001436RA079XR</basicUdiDi>
    <tradeName>PREP-MB-RAPID II DNA 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-124-P/9EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:53:29.776Z</lastUpdated>
  </row>
  <row>
    <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>
    <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>P-036-N/1EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:52:58.661Z</lastUpdated>
  </row>
  <row>
    <udiDi>04660014364763</udiDi>
    <basicUdiDi>466001436RA041WY</basicUdiDi>
    <tradeName>PREP-NA PLUS DNA/RNA Extraction Kit, Package N 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>P-036-N/2EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:52:48.197Z</lastUpdated>
  </row>
  <row>
    <udiDi>04660014363087</udiDi>
    <basicUdiDi>466001436RA060X4</basicUdiDi>
    <tradeName>PREP-OPTIMA 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>
    <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>P-016-N/2EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:51:48.205Z</lastUpdated>
  </row>
  <row>
    <udiDi>04660014363094</udiDi>
    <basicUdiDi>466001436RA060X4</basicUdiDi>
    <tradeName>PREP-OPTIMA MAX 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>
    <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>P-015-N/2EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:51:39.641Z</lastUpdated>
  </row>
  <row>
    <udiDi>04660014364060</udiDi>
    <basicUdiDi>466001436RA085XL</basicUdiDi>
    <tradeName>PREP-MB-DBS DWP DNA Extraction Kit, package P, Set No. 1</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>W0105900103</emdnCode>
    <emdnDescription>SUPPLEMENTAL NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Р-128-P/9EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:48:30.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>04660014364909</udiDi>
    <basicUdiDi>466001436RA085XL</basicUdiDi>
    <tradeName>PREP-MB-DBS DWP DNA 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>W0105900103</emdnCode>
    <emdnDescription>SUPPLEMENTAL NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Р-129-P/9EU</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-14T19:48:28.446Z</lastUpdated>
  </row>
</eudamedExport>