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<eudamedExport entity="devices">
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    <udiDi>00810195240460</udiDi>
    <basicUdiDi>B-00810195240460</basicUdiDi>
    <tradeName>Continuous Single Culture (CSCM) with Gentamicin</tradeName>
    <deviceName>Continuous Single Culture (CSCM) with Gentamicin</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>MDD</legislation>
    <emdnCode>U08020503</emdnCode>
    <emdnDescription>MATERIALS/CULTURE MEDIA FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90164</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:41:25.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240439</udiDi>
    <basicUdiDi>B-00810195240439</basicUdiDi>
    <tradeName>Modified HTF Medium-HEPES with Gentamicin</tradeName>
    <deviceName>Modified HTF Medium-HEPES with Gentamicin</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>MDD</legislation>
    <emdnCode>U08020502</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90126</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:41:24.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240422</udiDi>
    <basicUdiDi>B-00810195240422</basicUdiDi>
    <tradeName>Modified HTF Medium-HEPES with Gentamicin</tradeName>
    <deviceName>Modified HTF Medium - HEPES with Gentamicin</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>MDD</legislation>
    <emdnCode>U08020502</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90126</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:41:22.824Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240378</udiDi>
    <basicUdiDi>B-00810195240378</basicUdiDi>
    <tradeName>ISolate Stock Solution</tradeName>
    <deviceName>ISolate Stock Solution</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>MDD</legislation>
    <emdnCode>U08020502</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99275</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:41:20.428Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240361</udiDi>
    <basicUdiDi>B-00810195240361</basicUdiDi>
    <tradeName>ISolate Ready to Use Density Gradient Medium at Two Concentrations</tradeName>
    <deviceName>ISolate Ready to Use Density Gradient Medium at Two Concentrations</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>MDD</legislation>
    <emdnCode>U08020502</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99264</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:41:18.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240354</udiDi>
    <basicUdiDi>B-00810195240354</basicUdiDi>
    <tradeName>ISolate Ready to Use Density Gradient Medium at Two Concentrations</tradeName>
    <deviceName>ISolate Ready to Use Density Gradient Medium at Two Concentrations</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>MDD</legislation>
    <emdnCode>U08020502</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>99264</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:41:18.030Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240347</udiDi>
    <basicUdiDi>B-00810195240347</basicUdiDi>
    <tradeName>Vit Kit - Thaw</tradeName>
    <deviceName>Vitrification Thaw Kit (Vit Kit - Thaw)</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>MDD</legislation>
    <emdnCode>U08020501</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR FREEZING/THAWING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90137-DSOC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:41:16.418Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240330</udiDi>
    <basicUdiDi>B-00810195240330</basicUdiDi>
    <tradeName>Vit Kit - Thaw</tradeName>
    <deviceName>Vitrification Thaw Kit (Vit Kit - Thaw)</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>MDD</legislation>
    <emdnCode>U08020501</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR FREEZING/THAWING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90137-SO</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:41:14.020Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240323</udiDi>
    <basicUdiDi>B-00810195240323</basicUdiDi>
    <tradeName>Vit Kit - Freeze NX</tradeName>
    <deviceName>Vitrification Freeze Kit (Vit Kit - Freeze)</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>MDD</legislation>
    <emdnCode>U08020501</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR FREEZING/THAWING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90133-DSOC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:41:12.414Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240316</udiDi>
    <basicUdiDi>B-00810195240316</basicUdiDi>
    <tradeName>Vit Kit - Freeze</tradeName>
    <deviceName>Vitrification Freeze Kit (Vit Kit - Freeze)</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>MDD</legislation>
    <emdnCode>U08020501</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR FREEZING/THAWING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90133-SO</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:41:11.674Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240309</udiDi>
    <basicUdiDi>B-00810195240309</basicUdiDi>
    <tradeName>Vit Kit - Freeze NX</tradeName>
    <deviceName>Vit Kit - Freeze NX</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>MDD</legislation>
    <emdnCode>U08020501</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR FREEZING/THAWING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90188</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:41:10.028Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240293</udiDi>
    <basicUdiDi>B-00810195240293</basicUdiDi>
    <tradeName>Vit Kit - Warm NX</tradeName>
    <deviceName>Vit Kit - Warm NX</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>MDD</legislation>
    <emdnCode>U08020501</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR FREEZING/THAWING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90183</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:41:07.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240286</udiDi>
    <basicUdiDi>B-00810195240286</basicUdiDi>
    <tradeName>Multipurpose Handling Medium-Complete (MHM-C)</tradeName>
    <deviceName>Multipurpose Handling Medium-Complete (MHM-C)</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>MDD</legislation>
    <emdnCode>U08020502</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90166</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:41:06.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240279</udiDi>
    <basicUdiDi>B-00810195240279</basicUdiDi>
    <tradeName>Multipurpose Handling Medium-Complete (MHM-C)</tradeName>
    <deviceName>Multipurpose Handling Medium-Complete (MHM-C)</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>MDD</legislation>
    <emdnCode>U08020502</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90166</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:41:05.224Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240262</udiDi>
    <basicUdiDi>B-00810195240262</basicUdiDi>
    <tradeName>Multipurpose Handling Medium-Complete (MHM-C)</tradeName>
    <deviceName>Multipurpose Handling Medium-Complete (MHM-C)</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>MDD</legislation>
    <emdnCode>U08020502</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90166</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:41:03.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240255</udiDi>
    <basicUdiDi>B-00810195240255</basicUdiDi>
    <tradeName>Multipurpose Handling Medium (MHM) with Gentamicin</tradeName>
    <deviceName>Multipurpose Handling Medium (MHM) with Gentamicin</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>MDD</legislation>
    <emdnCode>U08020502</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90163</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:41:01.212Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240248</udiDi>
    <basicUdiDi>B-00810195240248</basicUdiDi>
    <tradeName>Multipurpose Handling Medium (MHM) with Gentamicin</tradeName>
    <deviceName>Multipurpose Handling Medium (MHM) with Gentamicin</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>MDD</legislation>
    <emdnCode>U08020502</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90163</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:59.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240231</udiDi>
    <basicUdiDi>B-00810195240231</basicUdiDi>
    <tradeName>Hyaluronidase Solution</tradeName>
    <deviceName>Hyaluronidase Solution</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>MDD</legislation>
    <emdnCode>U08020502</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:58.815Z</lastUpdated>
  </row>
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    <udiDi>00810195240217</udiDi>
    <basicUdiDi>B-00810195240217</basicUdiDi>
    <tradeName>Oil for Embryo Culture</tradeName>
    <deviceName>Oil for Embryo Culture</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>MDD</legislation>
    <emdnCode>U08020502</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9305-100mL</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:57.221Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240187</udiDi>
    <basicUdiDi>B-00810195240187</basicUdiDi>
    <tradeName>Human Serum Albumin (HSA)</tradeName>
    <deviceName>Human Serum Albumin</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>MDD</legislation>
    <emdnCode>U08020502</emdnCode>
    <emdnDescription>MATERIALS/SOLUTIONS FOR PREPARATION/HANDLING FOR ASSISTED REPRODUCTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9988</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:54.811Z</lastUpdated>
  </row>
</eudamedExport>