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    <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-718-T1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:16:45.830Z</lastUpdated>
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    <udiDi>00827002234963</udiDi>
    <basicUdiDi>B-00827002234963</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-630-T1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:16:45.031Z</lastUpdated>
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    <udiDi>00827002234956</udiDi>
    <basicUdiDi>B-00827002234956</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-628-T1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:16:44.230Z</lastUpdated>
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    <udiDi>00827002234949</udiDi>
    <basicUdiDi>B-00827002234949</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-626-T1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:16:43.436Z</lastUpdated>
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    <udiDi>00827002234932</udiDi>
    <basicUdiDi>B-00827002234932</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-624-T1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:16:39.415Z</lastUpdated>
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    <udiDi>00827002234925</udiDi>
    <basicUdiDi>B-00827002234925</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-622-T1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:16:38.619Z</lastUpdated>
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    <udiDi>00827002234918</udiDi>
    <basicUdiDi>B-00827002234918</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-620-T1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:16:37.819Z</lastUpdated>
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  <row>
    <udiDi>00827002233324</udiDi>
    <basicUdiDi>B-00827002233324</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-800-T1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:16:37.022Z</lastUpdated>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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