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    <basicUdiDi>122000026NATERCK5</basicUdiDi>
    <tradeName>01220000260030</tradeName>
    <deviceName>NATtrol™ Chlamydia trachomatis Positive Control Pack</deviceName>
    <manufacturerName>ZeptoMetrix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000035245</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010203</emdnCode>
    <emdnDescription>GONOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NATNG-6MC-IVD</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:22:45.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>01220000260023</udiDi>
    <basicUdiDi>122000026NATERCK5</basicUdiDi>
    <tradeName>01220000260023</tradeName>
    <deviceName>NATtrol™ Chlamydia trachomatis Positive Control Pack</deviceName>
    <manufacturerName>ZeptoMetrix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000035245</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010117</emdnCode>
    <emdnDescription>CHLAMYDIA TRACHOMATIS DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NATCT(434)-6MC-IVD</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:15:51.304Z</lastUpdated>
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  <row>
    <udiDi>01220000260047</udiDi>
    <basicUdiDi>122000026NATERCK5</basicUdiDi>
    <tradeName>01220000260047</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ZeptoMetrix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000035245</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CHLAMYDIA TRACHOMATIS DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NATCTNGNEG-6MC-IVD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:35:24.938Z</lastUpdated>
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    <udiDi>01220000260054</udiDi>
    <basicUdiDi>122000026NATERCK5</basicUdiDi>
    <tradeName>01220000260054</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ZeptoMetrix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000035245</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NATCDI-6MC-IVD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:35:24.922Z</lastUpdated>
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  <row>
    <udiDi>01220000260061</udiDi>
    <basicUdiDi>122000026NATERCK5</basicUdiDi>
    <tradeName>01220000260061</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ZeptoMetrix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000035245</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>C.DIFFICILE BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NATCSO-6MC-IVD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:35:24.904Z</lastUpdated>
  </row>
  <row>
    <udiDi>01220000260078</udiDi>
    <basicUdiDi>122000026NATERCK5</basicUdiDi>
    <tradeName>01220000260078</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ZeptoMetrix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000035245</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NATCXVA9-6C-IVD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:35:24.891Z</lastUpdated>
  </row>
  <row>
    <udiDi>01220000260085</udiDi>
    <basicUdiDi>122000026NATERCK5</basicUdiDi>
    <tradeName>01220000260085</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ZeptoMetrix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000035245</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NATFLUAB-6C-IVD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:35:24.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>01220000260092</udiDi>
    <basicUdiDi>122000026NATERCK5</basicUdiDi>
    <tradeName>01220000260092</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ZeptoMetrix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000035245</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RESPIRATORY SYNCYTIAL VIRUS (RSV) - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NATRSV-6C-IVD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:35:24.868Z</lastUpdated>
  </row>
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    <udiDi>01220000260108</udiDi>
    <basicUdiDi>122000026NATERCK5</basicUdiDi>
    <tradeName>01220000260108</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ZeptoMetrix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000035245</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NOROVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NATNOV-6MC-IVD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:35:24.858Z</lastUpdated>
  </row>
  <row>
    <udiDi>01220000260139</udiDi>
    <basicUdiDi>122000026NATERCK5</basicUdiDi>
    <tradeName>01220000260139</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ZeptoMetrix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000035245</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>NOROVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NATROTA-6MC-IVD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:35:24.844Z</lastUpdated>
  </row>
  <row>
    <udiDi>01220000260146</udiDi>
    <basicUdiDi>122000026NATERCK5</basicUdiDi>
    <tradeName>01220000260146</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ZeptoMetrix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000035245</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STREP. PNEUMONIAE DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NATSAG-6MC-IVD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:35:24.829Z</lastUpdated>
  </row>
  <row>
    <udiDi>01220000260153</udiDi>
    <basicUdiDi>122000026NATERCK5</basicUdiDi>
    <tradeName>01220000260153</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ZeptoMetrix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000035245</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>STREP. PNEUMONIAE DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NATLAC-6MC-IVD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:35:24.816Z</lastUpdated>
  </row>
  <row>
    <udiDi>01220000260184</udiDi>
    <basicUdiDi>122000026NATERCK5</basicUdiDi>
    <tradeName>01220000260184</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ZeptoMetrix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000035245</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRICHOMONAS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NATTVPOS-6MC-IVD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:35:24.804Z</lastUpdated>
  </row>
  <row>
    <udiDi>01220000260191</udiDi>
    <basicUdiDi>122000026NATERCK5</basicUdiDi>
    <tradeName>01220000260191</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ZeptoMetrix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000035245</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>TRICHOMONAS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NATTVNEG-6MC-IVD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:35:24.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>01220000260207</udiDi>
    <basicUdiDi>122000026NATERCK5</basicUdiDi>
    <tradeName>01220000260207</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ZeptoMetrix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000035245</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NATMRSA-6MC-IVD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:35:24.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>01220000260214</udiDi>
    <basicUdiDi>122000026NATERCK5</basicUdiDi>
    <tradeName>01220000260214</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ZeptoMetrix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000035245</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NATMSSE-6MC-IVD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:35:24.761Z</lastUpdated>
  </row>
  <row>
    <udiDi>01220000260221</udiDi>
    <basicUdiDi>122000026NATERCK5</basicUdiDi>
    <tradeName>01220000260221</tradeName>
    <deviceName></deviceName>
    <manufacturerName>ZeptoMetrix LLC</manufacturerName>
    <manufacturerSrn>US-MF-000035245</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>SAPHYLOCOCCAL DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NATMSSA-6MC-IVD</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-24T02:35:24.745Z</lastUpdated>
  </row>
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