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    <basicUdiDi>0850027600R2140FM</basicUdiDi>
    <tradeName>Quick-RNA Viral 96 Kit - DX (2 x 96 preps)</tradeName>
    <deviceName>Quick-DNA/RNA Viral MagBead-DX 250 prep</deviceName>
    <manufacturerName>Zymo Research Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000019308</manufacturerSrn>
    <authorisedRepresentativeName>DAVID Catherine Elisabeth Marie</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000006724</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>R1040-E</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:21:40.928Z</lastUpdated>
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    <udiDi>00850027600178</udiDi>
    <basicUdiDi>0850027600D4032B5</basicUdiDi>
    <tradeName>ZymoBIOMICS 96 MagBead DNA Kit (Lysis Rack)</tradeName>
    <deviceName>ZymoBIOMICS 96 MagBead DNA Kit (Lysis Rack)</deviceName>
    <manufacturerName>Zymo Research Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000019308</manufacturerSrn>
    <authorisedRepresentativeName>DAVID Catherine Elisabeth Marie</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>D4302-E</reference>
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    <udiDi>00850027600062</udiDi>
    <basicUdiDi>0850027600D5033BE</basicUdiDi>
    <tradeName>EZ-96 DNA Methylation-Lightning Kit (Deep-Well) - 2 x 96 Rxns</tradeName>
    <deviceName>EZ-96 DNA Methylation-Lightning Kit (Deep-Well)</deviceName>
    <manufacturerName>Zymo Research Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000019308</manufacturerSrn>
    <authorisedRepresentativeName>DAVID Catherine Elisabeth Marie</authorisedRepresentativeName>
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    <emdnDescription>REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>D5033-E</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:21:20.753Z</lastUpdated>
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    <udiDi>00850027600055</udiDi>
    <basicUdiDi>0850027600D5032BC</basicUdiDi>
    <tradeName>EZ-96 DNA Methylation-Lightning Kit (Shallow-Well) -2 x 96 Rxns</tradeName>
    <deviceName>EZ-96 DNA Methylation-Lightning Kit (Shallow-Well)</deviceName>
    <manufacturerName>Zymo Research Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000019308</manufacturerSrn>
    <authorisedRepresentativeName>DAVID Catherine Elisabeth Marie</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000006724</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>Artık piyasada değil</deviceStatus>
    <reference>D5032-E</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:21:19.155Z</lastUpdated>
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    <udiDi>00850027600017</udiDi>
    <basicUdiDi>0850027600D5030B8</basicUdiDi>
    <tradeName>EZ DNA Methylation-Lightning Kit (50 Rxns)</tradeName>
    <deviceName>EZ DNA Methylation-Lightning Kit (50 Rxns)</deviceName>
    <manufacturerName>Zymo Research Corp.</manufacturerName>
    <manufacturerSrn>US-MF-000019308</manufacturerSrn>
    <authorisedRepresentativeName>DAVID Catherine Elisabeth Marie</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000006724</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>D5030-E</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:21:16.752Z</lastUpdated>
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    <udiDi>00850024414068</udiDi>
    <basicUdiDi>0850024414FFPERNAEXXV</basicUdiDi>
    <tradeName>00850024414068</tradeName>
    <deviceName>Veracyte FFPE RNA Extraction Kit</deviceName>
    <manufacturerName>Veracyte, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000048711</manufacturerSrn>
    <authorisedRepresentativeName>Veracyte Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000047758</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>550100</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:20:44.737Z</lastUpdated>
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    <udiDi>07332940006013</udiDi>
    <basicUdiDi>081164701-GXFFPE-LYSIS-MP</basicUdiDi>
    <tradeName>Xpert®</tradeName>
    <deviceName>Xpert® FFPE Lysis Kit</deviceName>
    <manufacturerName>Cepheid</manufacturerName>
    <manufacturerSrn>US-MF-000010979</manufacturerSrn>
    <authorisedRepresentativeName>Cepheid AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000048904</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>GXFFPE-LYSIS-CE-10</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:13:32.830Z</lastUpdated>
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    <udiDi>37604277000332</udiDi>
    <basicUdiDi>376042770112B4</basicUdiDi>
    <tradeName>Extraction and purification kit of NA for blood 24R IVD</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AD Nucleis</manufacturerName>
    <manufacturerSrn>FR-MF-000002215</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>KIT-EP_24_112_I_PF</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:55:53.994Z</lastUpdated>
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    <udiDi>37604277000400</udiDi>
    <basicUdiDi>376042770112B4</basicUdiDi>
    <tradeName>This device is used to extract DNA/RNA from EDTA blood samples</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AD Nucleis</manufacturerName>
    <manufacturerSrn>FR-MF-000002215</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>KIT-EP_14_112_I_PF</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:54:40.373Z</lastUpdated>
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    <udiDi>10190302019170</udiDi>
    <basicUdiDi>0190302MagMAXDxDN</basicUdiDi>
    <tradeName>MagMax</tradeName>
    <deviceName>Nucleic acid isolation and purification in vitro diagnostic kit</deviceName>
    <manufacturerName>Thermo Fisher Scientific Baltics UAB</manufacturerName>
    <manufacturerSrn>LT-MF-000046574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>A52735</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:50:57.239Z</lastUpdated>
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    <basicUdiDi>0190302MVP2TT</basicUdiDi>
    <tradeName>MagMax</tradeName>
    <deviceName>Nucleic acid isolation and purification in vitro diagnostic kit</deviceName>
    <manufacturerName>Thermo Fisher Scientific Baltics UAB</manufacturerName>
    <manufacturerSrn>LT-MF-000046574</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>A48383</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:50:49.224Z</lastUpdated>
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    <udiDi>00849811004452</udiDi>
    <basicUdiDi>00849811004452JT</basicUdiDi>
    <tradeName>Abbott mSample Preparation SystemDNA</tradeName>
    <deviceName>Abbott mSample Preparation SystemDNA</deviceName>
    <manufacturerName>Promega Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000034520</manufacturerSrn>
    <authorisedRepresentativeName>Abbott GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009457</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>06K12-24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:33:39.998Z</lastUpdated>
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    <udiDi>00849811004445</udiDi>
    <basicUdiDi>00849811004445JW</basicUdiDi>
    <tradeName>Abbott mSample Preparation System</tradeName>
    <deviceName>Abbott mSample Preparation System</deviceName>
    <manufacturerName>Promega Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000034520</manufacturerSrn>
    <authorisedRepresentativeName>Abbott GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009457</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>04J70-24</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:33:39.038Z</lastUpdated>
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    <udiDi>00840733101823</udiDi>
    <basicUdiDi>008407331ALETHIACLC011RE</basicUdiDi>
    <tradeName>M-prep - DNA Sample Preparation Kit</tradeName>
    <deviceName>M-prep - DNA Sample Preparation Kit</deviceName>
    <manufacturerName>Meridian Bioscience Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044096</manufacturerSrn>
    <authorisedRepresentativeName>Meridian Bioscience Europe S.r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000010460</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>281110</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:24:51.110Z</lastUpdated>
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    <udiDi>+G226DX2960001</udiDi>
    <basicUdiDi>++G226UrineTotRNAPKit7K</basicUdiDi>
    <tradeName>+G226DX2960001</tradeName>
    <deviceName>Urine Total RNA Purification Maxi 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>Dx29600</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T17:19:21.608Z</lastUpdated>
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    <udiDi>EVIRUVCUCS1</udiDi>
    <basicUdiDi>++EVIRSubstrateKT</basicUdiDi>
    <tradeName>ViraChip Chromogen / Substrate Solution</tradeName>
    <deviceName>Substrate</deviceName>
    <manufacturerName>Viramed Biotech AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020368</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>V-UVCUCS</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:24:31.470Z</lastUpdated>
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    <udiDi>EVIRUVCAKI1</udiDi>
    <basicUdiDi>++EVIRConjugate5E</basicUdiDi>
    <tradeName>ViraChip® AP-Anti-Human IgA Conjugate</tradeName>
    <deviceName>Conjugate</deviceName>
    <manufacturerName>Viramed Biotech AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020368</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>V-UVCAKI</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:24:25.184Z</lastUpdated>
  </row>
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    <udiDi>+EVIRUVCPWP1</udiDi>
    <basicUdiDi>++EVIRReagentwithoutCoT8P</basicUdiDi>
    <tradeName>ViraChip Wash Buffer Plus</tradeName>
    <deviceName>Universal Reagent without Cells or Tissues</deviceName>
    <manufacturerName>Viramed Biotech AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020368</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>V-UVCPWP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:21:36.332Z</lastUpdated>
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    <udiDi>+EVIRUVCPPP1</udiDi>
    <basicUdiDi>++EVIRReagentwithCoTQB</basicUdiDi>
    <tradeName>ViraChip Sample Buffer Plus</tradeName>
    <deviceName>Universal Reagent with Cells or Tissues or Derivatives thereof</deviceName>
    <manufacturerName>Viramed Biotech AG</manufacturerName>
    <manufacturerSrn>DE-MF-000020368</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>V-UVCPPP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:21:35.648Z</lastUpdated>
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    <udiDi>+ENTIWE2000809</udiDi>
    <basicUdiDi>++ENTIWE20008V037L</basicUdiDi>
    <tradeName>Verd.-/Waschpuffer  Dilution-/Washbuffer LINE</tradeName>
    <deviceName>Verd.-/Waschpuffer  Dilution-/Washbuffer 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>WE200.08</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:09:25.496Z</lastUpdated>
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