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<eudamedExport entity="devices">
  <row>
    <udiDi>00810195240590</udiDi>
    <basicUdiDi>B-00810195240590</basicUdiDi>
    <tradeName>CHANG AMNIO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Irvine Scientific, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000007514</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99473-100mL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T03:33:02.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240606</udiDi>
    <basicUdiDi>B-00810195240606</basicUdiDi>
    <tradeName>CHANG MEDIUM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Irvine Scientific, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000007514</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C100-90mL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T03:33:02.457Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240613</udiDi>
    <basicUdiDi>B-00810195240613</basicUdiDi>
    <tradeName>CHANG MEDIUM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Irvine Scientific, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000007514</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C106-14mL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T03:33:02.201Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240620</udiDi>
    <basicUdiDi>B-00810195240620</basicUdiDi>
    <tradeName>CHANG MEDIUM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Irvine Scientific, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000007514</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T105-100mL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T03:33:02.079Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240637</udiDi>
    <basicUdiDi>B-00810195240637</basicUdiDi>
    <tradeName>CHANG MEDIUM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Irvine Scientific, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000007514</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T105-500mL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-02T03:33:01.525Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240545</udiDi>
    <basicUdiDi>B-00810195240545</basicUdiDi>
    <tradeName>CHANG MEDIUM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Irvine Scientific, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000007514</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91005-100mL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:41:58.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240569</udiDi>
    <basicUdiDi>B-00810195240569</basicUdiDi>
    <tradeName>CHANG Marrow</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Irvine Scientific, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000007514</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91031-100mL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:41:58.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240576</udiDi>
    <basicUdiDi>B-00810195240576</basicUdiDi>
    <tradeName>CHANG Marrow</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Irvine Scientific, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000007514</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>91031-500mL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:41:57.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240408</udiDi>
    <basicUdiDi>B-00810195240408</basicUdiDi>
    <tradeName>COLCEMID</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Irvine Scientific, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000007514</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9311-10mL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:41:56.432Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240583</udiDi>
    <basicUdiDi>B-00810195240583</basicUdiDi>
    <tradeName>CHANG MEDIUM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Irvine Scientific, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000007514</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99404-100mL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:41:52.032Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240507</udiDi>
    <basicUdiDi>B-00810195240507</basicUdiDi>
    <tradeName>Continuous Single Culture - NX Complete (CSCM-NXC)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Irvine Scientific, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000007514</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U08020502</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T11:58:54.027Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240491</udiDi>
    <basicUdiDi>B-00810195240491</basicUdiDi>
    <tradeName>Continuous Single Culture - NX Complete (CSCM-NXC)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Irvine Scientific, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000007514</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U08020502</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T11:58:52.935Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240484</udiDi>
    <basicUdiDi>B-00810195240484</basicUdiDi>
    <tradeName>Continuous Single Culture - NX (CSCM-NX) with Gentamicin</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Irvine Scientific, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000007514</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U08020503</emdnCode>
    <emdnDescription>MATERIALS/CULTURE MEDIA FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T11:58:51.848Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240477</udiDi>
    <basicUdiDi>B-00810195240477</basicUdiDi>
    <tradeName>Continuous Single Culture Complete (CSCM-C)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Irvine Scientific, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000007514</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U08020502</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T11:58:50.750Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240460</udiDi>
    <basicUdiDi>B-00810195240460</basicUdiDi>
    <tradeName>Continuous Single Culture (CSCM) with Gentamicin</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Irvine Scientific, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000007514</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U08020503</emdnCode>
    <emdnDescription>MATERIALS/CULTURE MEDIA FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T11:58:49.656Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240439</udiDi>
    <basicUdiDi>B-00810195240439</basicUdiDi>
    <tradeName>Modified HTF Medium-HEPES with Gentamicin</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Irvine Scientific, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000007514</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U08020502</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T11:58:48.565Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240422</udiDi>
    <basicUdiDi>B-00810195240422</basicUdiDi>
    <tradeName>Modified HTF Medium-HEPES with Gentamicin</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Irvine Scientific, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000007514</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U08020502</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T11:58:47.465Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240378</udiDi>
    <basicUdiDi>B-00810195240378</basicUdiDi>
    <tradeName>ISolate Stock Solution</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Irvine Scientific, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000007514</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U08020502</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T11:58:46.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240361</udiDi>
    <basicUdiDi>B-00810195240361</basicUdiDi>
    <tradeName>ISolate Ready to Use Density Gradient Medium at Two Concentrations</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Irvine Scientific, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000007514</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U08020502</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T11:58:45.231Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240354</udiDi>
    <basicUdiDi>B-00810195240354</basicUdiDi>
    <tradeName>ISolate Ready to Use Density Gradient Medium at Two Concentrations</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Irvine Scientific, LLC.</manufacturerName>
    <manufacturerSrn>US-MF-000007514</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>U08020502</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference></reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-06T11:58:44.133Z</lastUpdated>
  </row>
</eudamedExport>