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    <udiDi>08595142249803</udiDi>
    <basicUdiDi>85951422146107L</basicUdiDi>
    <tradeName>GRAM II roztok</tradeName>
    <deviceName>GRAM II ROZTOK</deviceName>
    <manufacturerName>Ing. Petr Švec - PENTA s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000035988</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080203</emdnCode>
    <emdnDescription>GRAM POSITIVE - MANUAL IDENTIFICATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14610</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:55:11.790Z</lastUpdated>
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  <row>
    <udiDi>08595142249704</udiDi>
    <basicUdiDi>85951422146007H</basicUdiDi>
    <tradeName>GRAM I roztok</tradeName>
    <deviceName>GRAM I roztok</deviceName>
    <manufacturerName>Ing. Petr Švec - PENTA s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000035988</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080203</emdnCode>
    <emdnDescription>GRAM POSITIVE - MANUAL IDENTIFICATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>14600</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:55:10.179Z</lastUpdated>
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    <udiDi>08595142248059</udiDi>
    <basicUdiDi>85951422413107H</basicUdiDi>
    <tradeName>ACETONALKOHOL</tradeName>
    <deviceName>ACETONALKOHOL</deviceName>
    <manufacturerName>Ing. Petr Švec - PENTA s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000035988</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080203</emdnCode>
    <emdnDescription>GRAM POSITIVE - MANUAL IDENTIFICATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>41310</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:55:06.180Z</lastUpdated>
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    <udiDi>08595142247977</udiDi>
    <basicUdiDi>85951422412507Q</basicUdiDi>
    <tradeName>ZKOUMADLO ZIEHL-NEELSEN II</tradeName>
    <deviceName>ZKOUMADLO ZIEHL-NEELSEN II</deviceName>
    <manufacturerName>Ing. Petr Švec - PENTA s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000035988</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080299</emdnCode>
    <emdnDescription>MANUAL IDENTIFICATION - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>41250</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-03T13:55:03.783Z</lastUpdated>
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  <row>
    <udiDi>00848838031151</udiDi>
    <basicUdiDi>8488380Pathotec7W</basicUdiDi>
    <tradeName>PATHOTEC CO (CYTOCHROME OXIDASE)</tradeName>
    <deviceName>PATHOTEC CO (CYTOCHROME OXIDASE)</deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R38191</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:23:10.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838028892</udiDi>
    <basicUdiDi>8488380PYRDiskXB</basicUdiDi>
    <tradeName>PYR 50 TEST KIT</tradeName>
    <deviceName>PYR TEST KIT</deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R30854301</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:23:08.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838028625</udiDi>
    <basicUdiDi>8488380LAPDiskJR</basicUdiDi>
    <tradeName>LAP 50 TEST KIT</tradeName>
    <deviceName>LAP TEST KIT</deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R30168501</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:23:06.130Z</lastUpdated>
  </row>
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    <udiDi>00848838023088</udiDi>
    <basicUdiDi>8488380NitrocefinDisk47</basicUdiDi>
    <tradeName>NITROCEFIN DISK</tradeName>
    <deviceName>NITROCEFIN DISK</deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R211667</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:22.846Z</lastUpdated>
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  <row>
    <udiDi>00848838022746</udiDi>
    <basicUdiDi>8488380MicrodaseDiskAG</basicUdiDi>
    <tradeName>MICRODASE DISK</tradeName>
    <deviceName>MICRODASE DISK</deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21132</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:21.250Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838022593</udiDi>
    <basicUdiDi>8488380CatarrhalisDiskQM</basicUdiDi>
    <tradeName>CATARRHALIS TEST DISK</tradeName>
    <deviceName>CATARRHALIS TEST DISK</deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21121</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:18.959Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838022494</udiDi>
    <basicUdiDi>8488380BactiCardStrep3A</basicUdiDi>
    <tradeName>BACTICARD STREP</tradeName>
    <deviceName>BACTICARD STREP</deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080203</emdnCode>
    <emdnDescription>GRAM POSITIVE - MANUAL IDENTIFICATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21112</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:16.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838022470</udiDi>
    <basicUdiDi>8488380BctCrdNeisseriaBV</basicUdiDi>
    <tradeName>BACTICARD NEISSERIA</tradeName>
    <deviceName>BACTICARD NEISSERIA</deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080201</emdnCode>
    <emdnDescription>GRAM NEGATIVE - MANUAL IDENTIFICATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21110</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:15.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838022456</udiDi>
    <basicUdiDi>8488380BctCrdEcoliHQ</basicUdiDi>
    <tradeName>BACTICARD E. COLI</tradeName>
    <deviceName>BACTICARD E. COLI</deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080201</emdnCode>
    <emdnDescription>GRAM NEGATIVE - MANUAL IDENTIFICATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21108</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:14.047Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838022432</udiDi>
    <basicUdiDi>8488380BactiCardCandida8B</basicUdiDi>
    <tradeName>BACTICARD CANDIDA</tradeName>
    <deviceName>BACTICARD CANDIDA</deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080203</emdnCode>
    <emdnDescription>GRAM POSITIVE - MANUAL IDENTIFICATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21106</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:10.843Z</lastUpdated>
  </row>
  <row>
    <udiDi>00848838022333</udiDi>
    <basicUdiDi>8488380HippurateDiskTV</basicUdiDi>
    <tradeName>HIPPURATE DISK</tradeName>
    <deviceName>HIPPURATE DISK</deviceName>
    <manufacturerName>Remel, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000044686</manufacturerSrn>
    <authorisedRepresentativeName>Thermo Fisher Diagnostics B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000013157</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080208</emdnCode>
    <emdnDescription>SINGLE TESTS (DISCS, STRIPS, DROPPERS...)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R21085</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:22:09.238Z</lastUpdated>
  </row>
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    <udiDi>08050054131139</udiDi>
    <basicUdiDi>805005413TC56600S7</basicUdiDi>
    <tradeName>GRAM VIOLETTO CRISTALLI OSSALATO</tradeName>
    <deviceName>GRAM VIOLETTO CRISTALLI OSSALATO</deviceName>
    <manufacturerName>Titolchimica S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000028986</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080203</emdnCode>
    <emdnDescription>GRAM POSITIVE - MANUAL IDENTIFICATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TC56600OO</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:31:29.487Z</lastUpdated>
  </row>
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    <udiDi>08050054131122</udiDi>
    <basicUdiDi>805005413TC56000R9</basicUdiDi>
    <tradeName>DIFFERENZIATORE GRAM-HUCKER</tradeName>
    <deviceName>DIFFERENZIATORE GRAM-HUCKER</deviceName>
    <manufacturerName>Titolchimica S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000028986</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080203</emdnCode>
    <emdnDescription>GRAM POSITIVE - MANUAL IDENTIFICATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TC56000OO</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:31:27.907Z</lastUpdated>
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    <udiDi>08050054131108</udiDi>
    <basicUdiDi>805005413TC55900SF</basicUdiDi>
    <tradeName>GRAM SAFRANINA</tradeName>
    <deviceName>GRAM SAFRANINA</deviceName>
    <manufacturerName>Titolchimica S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000028986</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080203</emdnCode>
    <emdnDescription>GRAM POSITIVE - MANUAL IDENTIFICATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TC55900OO</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:31:27.085Z</lastUpdated>
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    <udiDi>08050054131092</udiDi>
    <basicUdiDi>805005413TC55401RQ</basicUdiDi>
    <tradeName>GRAM – KIT CON SAFRANINA sec. Hucker</tradeName>
    <deviceName>GRAM – KIT CON SAFRANINA sec. Hucker</deviceName>
    <manufacturerName>Titolchimica S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000028986</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080203</emdnCode>
    <emdnDescription>GRAM POSITIVE - MANUAL IDENTIFICATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TC55401</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:31:24.720Z</lastUpdated>
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    <udiDi>08050054131085</udiDi>
    <basicUdiDi>805005413TC45875SW</basicUdiDi>
    <tradeName>LUGOL KIT GRAM HUCKER</tradeName>
    <deviceName>LUGOL KIT GRAM HUCKER</deviceName>
    <manufacturerName>Titolchimica S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000028986</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0104080203</emdnCode>
    <emdnDescription>GRAM POSITIVE - MANUAL IDENTIFICATION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TC45875OO</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T05:31:22.283Z</lastUpdated>
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