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<eudamedExport entity="devices">
  <row>
    <udiDi>00827002233317</udiDi>
    <basicUdiDi>B-00827002233317</basicUdiDi>
    <tradeName>Universa®</tradeName>
    <deviceName>Universa® Soft Ureteral Stent Set with Monofilament Tether</deviceName>
    <manufacturerName>Cook Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000003180</manufacturerSrn>
    <authorisedRepresentativeName>COOK MEDICAL EUROPE LIMITED</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000907</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>U020302</emdnCode>
    <emdnDescription>DOUBLE LOOP URETERAL STENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>US-700-T1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:16:33.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240507</udiDi>
    <basicUdiDi>B-00810195240507</basicUdiDi>
    <tradeName>Continuous Single Culture - NX Complete (CSCM-NXC)</tradeName>
    <deviceName>Continuous Single Culture - NX Complete (CSCM-NXC)</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>90168</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:41:47.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240491</udiDi>
    <basicUdiDi>B-00810195240491</basicUdiDi>
    <tradeName>Continuous Single Culture - NX Complete (CSCM-NXC)</tradeName>
    <deviceName>Continuous Single Culture - NX Complete (CSCM-NXC)</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>90168</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:41:30.823Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240484</udiDi>
    <basicUdiDi>B-00810195240484</basicUdiDi>
    <tradeName>Continuous Single Culture - NX (CSCM-NX) with Gentamicin</tradeName>
    <deviceName>Continuous Single Culture - NX (CSCM-NX) 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>90167</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:41:29.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810195240477</udiDi>
    <basicUdiDi>B-00810195240477</basicUdiDi>
    <tradeName>Continuous Single Culture Complete (CSCM-C)</tradeName>
    <deviceName>Continuous Single Culture Complete (CSCM-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>90165</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:41:26.839Z</lastUpdated>
  </row>
  <row>
    <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>
</eudamedExport>