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<eudamedExport entity="devices">
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    <basicUdiDi>B-00834061000163</basicUdiDi>
    <tradeName>StatSeal</tradeName>
    <deviceName>StatSeal® Disc - Large</deviceName>
    <manufacturerName>Biolife, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008811</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M040504</emdnCode>
    <emdnDescription>INORGANIC HAEMOSTATIC DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DL016</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-04T20:08:11.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>00834061000156</udiDi>
    <basicUdiDi>B-00834061000156</basicUdiDi>
    <tradeName>StatSeal</tradeName>
    <deviceName>StatSeal® Disc - Medium</deviceName>
    <manufacturerName>Biolife, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008811</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M040504</emdnCode>
    <emdnDescription>INORGANIC HAEMOSTATIC DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DM015</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-04T20:08:07.765Z</lastUpdated>
  </row>
  <row>
    <udiDi>00834061000149</udiDi>
    <basicUdiDi>B-00834061000149</basicUdiDi>
    <tradeName>StatSeal</tradeName>
    <deviceName>StatSeal® Disc - Small</deviceName>
    <manufacturerName>Biolife, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008811</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M040504</emdnCode>
    <emdnDescription>INORGANIC HAEMOSTATIC DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DS014</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-04T20:08:06.066Z</lastUpdated>
  </row>
  <row>
    <udiDi>00834061000071</udiDi>
    <basicUdiDi>B-00834061000071</basicUdiDi>
    <tradeName>StatSeal</tradeName>
    <deviceName>StatSeal® Advanced Powder</deviceName>
    <manufacturerName>Biolife, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008811</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M040504</emdnCode>
    <emdnDescription>INORGANIC HAEMOSTATIC DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LP007</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-04T20:08:05.268Z</lastUpdated>
  </row>
  <row>
    <udiDi>00834061000064</udiDi>
    <basicUdiDi>B-00834061000064</basicUdiDi>
    <tradeName>StatSeal</tradeName>
    <deviceName>StatSeal® Powder</deviceName>
    <manufacturerName>Biolife, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008811</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M040504</emdnCode>
    <emdnDescription>INORGANIC HAEMOSTATIC DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LP006</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-04T20:08:04.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>18590317090089</udiDi>
    <basicUdiDi>85903170010SG</basicUdiDi>
    <tradeName>Traumastem FAM OcW</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSTER, a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M040501</emdnCode>
    <emdnDescription>POLYSACCHARIDE HAEMOSTATIC DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:53:55.273Z</lastUpdated>
  </row>
  <row>
    <udiDi>18590317090119</udiDi>
    <basicUdiDi>85903170010SG</basicUdiDi>
    <tradeName>Traumastem FAM Strata</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSTER, a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M040501</emdnCode>
    <emdnDescription>POLYSACCHARIDE HAEMOSTATIC DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:53:55.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>18590317090126</udiDi>
    <basicUdiDi>85903170010SG</basicUdiDi>
    <tradeName>Traumastem FAM Strata</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSTER, a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M040501</emdnCode>
    <emdnDescription>POLYSACCHARIDE HAEMOSTATIC DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:53:55.177Z</lastUpdated>
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  <row>
    <udiDi>18590317090133</udiDi>
    <basicUdiDi>85903170010SG</basicUdiDi>
    <tradeName>Traumastem FAM Strata</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSTER, a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M040501</emdnCode>
    <emdnDescription>POLYSACCHARIDE HAEMOSTATIC DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9013</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:53:55.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>18590317090140</udiDi>
    <basicUdiDi>85903170010SG</basicUdiDi>
    <tradeName>Traumastem FAM Trium</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSTER, a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M040501</emdnCode>
    <emdnDescription>POLYSACCHARIDE HAEMOSTATIC DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:53:55.116Z</lastUpdated>
  </row>
  <row>
    <udiDi>18590317090157</udiDi>
    <basicUdiDi>85903170010SG</basicUdiDi>
    <tradeName>Traumastem FAM Trium</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSTER, a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M040501</emdnCode>
    <emdnDescription>POLYSACCHARIDE HAEMOSTATIC DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9015</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:53:55.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>18590317090164</udiDi>
    <basicUdiDi>85903170010SG</basicUdiDi>
    <tradeName>Traumastem FAM Trium</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSTER, a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M040501</emdnCode>
    <emdnDescription>POLYSACCHARIDE HAEMOSTATIC DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9016</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:53:55.075Z</lastUpdated>
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  <row>
    <udiDi>18590317100283</udiDi>
    <basicUdiDi>85903170010SG</basicUdiDi>
    <tradeName>Traumastem TAF</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSTER, a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M040501</emdnCode>
    <emdnDescription>POLYSACCHARIDE HAEMOSTATIC DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10028</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:53:55.056Z</lastUpdated>
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  <row>
    <udiDi>18590317100450</udiDi>
    <basicUdiDi>85903170010SG</basicUdiDi>
    <tradeName>Traumastem</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSTER, a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M040501</emdnCode>
    <emdnDescription>POLYSACCHARIDE HAEMOSTATIC DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10045</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:53:55.025Z</lastUpdated>
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  <row>
    <udiDi>18590317100467</udiDi>
    <basicUdiDi>85903170010SG</basicUdiDi>
    <tradeName>Traumastem</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSTER, a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M040501</emdnCode>
    <emdnDescription>POLYSACCHARIDE HAEMOSTATIC DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10046</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:53:54.999Z</lastUpdated>
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  <row>
    <udiDi>18590317100474</udiDi>
    <basicUdiDi>85903170010SG</basicUdiDi>
    <tradeName>Traumastem</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSTER, a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M040501</emdnCode>
    <emdnDescription>POLYSACCHARIDE HAEMOSTATIC DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10047</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:53:54.981Z</lastUpdated>
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    <udiDi>18590317100481</udiDi>
    <basicUdiDi>85903170010SG</basicUdiDi>
    <tradeName>Traumastem</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSTER, a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M040501</emdnCode>
    <emdnDescription>POLYSACCHARIDE HAEMOSTATIC DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10048</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:53:54.965Z</lastUpdated>
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    <udiDi>18590317100511</udiDi>
    <basicUdiDi>85903170010SG</basicUdiDi>
    <tradeName>Traumastem Fibrillar</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSTER, a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M040501</emdnCode>
    <emdnDescription>POLYSACCHARIDE HAEMOSTATIC DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10051</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:53:54.948Z</lastUpdated>
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    <udiDi>18590317100528</udiDi>
    <basicUdiDi>85903170010SG</basicUdiDi>
    <tradeName>Traumastem Fibrillar</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSTER, a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M040501</emdnCode>
    <emdnDescription>POLYSACCHARIDE HAEMOSTATIC DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10052</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:53:54.931Z</lastUpdated>
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    <udiDi>18590317100535</udiDi>
    <basicUdiDi>85903170010SG</basicUdiDi>
    <tradeName>Traumastem Fibrillar</tradeName>
    <deviceName></deviceName>
    <manufacturerName>BIOSTER, a.s.</manufacturerName>
    <manufacturerSrn>CZ-MF-000011615</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>M040501</emdnCode>
    <emdnDescription>POLYSACCHARIDE HAEMOSTATIC DRESSINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10053</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:53:54.911Z</lastUpdated>
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