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<eudamedExport entity="devices">
  <row>
    <udiDi>05906118033495</udiDi>
    <basicUdiDi>B-05906118033495</basicUdiDi>
    <tradeName>Acron ALM</tradeName>
    <deviceName>Acron ALM</deviceName>
    <manufacturerName>ROKO SP. Z O.O.</manufacturerName>
    <manufacturerSrn>PL-MF-000050171</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ALM</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T21:34:16.772Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906118033488</udiDi>
    <basicUdiDi>B-05906118033488</basicUdiDi>
    <tradeName>Acron AP 250g</tradeName>
    <deviceName>Acron AP 250g</deviceName>
    <manufacturerName>ROKO SP. Z O.O.</manufacturerName>
    <manufacturerSrn>PL-MF-000050171</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AP250</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T21:34:12.763Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906118033471</udiDi>
    <basicUdiDi>B-05906118033471</basicUdiDi>
    <tradeName>ACRON APL</tradeName>
    <deviceName>Acron APL</deviceName>
    <manufacturerName>ROKO SP. Z O.O.</manufacturerName>
    <manufacturerSrn>PL-MF-000050171</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APL</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T21:34:11.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906118033464</udiDi>
    <basicUdiDi>B-05906118033464</basicUdiDi>
    <tradeName>ACRON APS</tradeName>
    <deviceName>Acron APS</deviceName>
    <manufacturerName>ROKO SP. Z O.O.</manufacturerName>
    <manufacturerSrn>PL-MF-000050171</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APS</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T21:34:11.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906118033457</udiDi>
    <basicUdiDi>B-05906118033457</basicUdiDi>
    <tradeName>ACRON APM</tradeName>
    <deviceName>Acron APM</deviceName>
    <manufacturerName>ROKO SP. Z O.O.</manufacturerName>
    <manufacturerSrn>PL-MF-000050171</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>APM</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T21:34:10.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906118033440</udiDi>
    <basicUdiDi>B-05906118033440</basicUdiDi>
    <tradeName>Acron AJ 250g</tradeName>
    <deviceName>Acron AJ 250g</deviceName>
    <manufacturerName>ROKO SP. Z O.O.</manufacturerName>
    <manufacturerSrn>PL-MF-000050171</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AJ250</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T21:34:06.352Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906118033433</udiDi>
    <basicUdiDi>B-05906118033433</basicUdiDi>
    <tradeName>ACRON AJL</tradeName>
    <deviceName>Acron AJL</deviceName>
    <manufacturerName>ROKO SP. Z O.O.</manufacturerName>
    <manufacturerSrn>PL-MF-000050171</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AJL</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T21:34:05.552Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906118033426</udiDi>
    <basicUdiDi>B-05906118033426</basicUdiDi>
    <tradeName>ACRON AJS</tradeName>
    <deviceName>ACRON AJS</deviceName>
    <manufacturerName>ROKO SP. Z O.O.</manufacturerName>
    <manufacturerSrn>PL-MF-000050171</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AJS</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T21:34:04.756Z</lastUpdated>
  </row>
  <row>
    <udiDi>05906118033419</udiDi>
    <basicUdiDi>B-05906118033419</basicUdiDi>
    <tradeName>ACRON AJM</tradeName>
    <deviceName>ACRON AJM</deviceName>
    <manufacturerName>ROKO SP. Z O.O.</manufacturerName>
    <manufacturerSrn>PL-MF-000050171</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AJM</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T21:34:03.952Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901421261184</udiDi>
    <basicUdiDi>B-05901421261184</basicUdiDi>
    <tradeName>Biocetal R3 500g</tradeName>
    <deviceName>Biocetal R3 500g</deviceName>
    <manufacturerName>ROKO SP. Z O.O.</manufacturerName>
    <manufacturerSrn>PL-MF-000050171</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BR3 500</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:01:24.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901421261177</udiDi>
    <basicUdiDi>B-05901421261177</basicUdiDi>
    <tradeName>Biocetal R3 250g</tradeName>
    <deviceName>Biocetal R3 250g</deviceName>
    <manufacturerName>ROKO SP. Z O.O.</manufacturerName>
    <manufacturerSrn>PL-MF-000050171</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BR3 250</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:01:20.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901421261160</udiDi>
    <basicUdiDi>B-05901421261160</basicUdiDi>
    <tradeName>Biocetal R3L</tradeName>
    <deviceName>Biocetal R3L</deviceName>
    <manufacturerName>ROKO SP. Z O.O.</manufacturerName>
    <manufacturerSrn>PL-MF-000050171</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BR3L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:01:19.568Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901421261153</udiDi>
    <basicUdiDi>B-05901421261153</basicUdiDi>
    <tradeName>Biocetal R3M</tradeName>
    <deviceName>Biocetal R3M</deviceName>
    <manufacturerName>ROKO SP. Z O.O.</manufacturerName>
    <manufacturerSrn>PL-MF-000050171</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BR3M</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:01:18.764Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901421261146</udiDi>
    <basicUdiDi>B-05901421261146</basicUdiDi>
    <tradeName>Biocetal R3S</tradeName>
    <deviceName>Biocetal R3S</deviceName>
    <manufacturerName>ROKO SP. Z O.O.</manufacturerName>
    <manufacturerSrn>PL-MF-000050171</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BR3S</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:01:17.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901421261139</udiDi>
    <basicUdiDi>B-05901421261139</basicUdiDi>
    <tradeName>Biocetal R2S</tradeName>
    <deviceName>Biocetal R2S</deviceName>
    <manufacturerName>ROKO SP. Z O.O.</manufacturerName>
    <manufacturerSrn>PL-MF-000050171</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BR2S</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:01:13.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901421261122</udiDi>
    <basicUdiDi>B-05901421261122</basicUdiDi>
    <tradeName>Biocetal R2M</tradeName>
    <deviceName>Biocetal R2M</deviceName>
    <manufacturerName>ROKO SP. Z O.O.</manufacturerName>
    <manufacturerSrn>PL-MF-000050171</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BR2M</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:01:13.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901421261115</udiDi>
    <basicUdiDi>B-05901421261115</basicUdiDi>
    <tradeName>Biocetal R2L</tradeName>
    <deviceName>Biocetal R2L</deviceName>
    <manufacturerName>ROKO SP. Z O.O.</manufacturerName>
    <manufacturerSrn>PL-MF-000050171</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BR2L</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:01:12.347Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901421261108</udiDi>
    <basicUdiDi>B-05901421261108</basicUdiDi>
    <tradeName>Biocetal R2 250g</tradeName>
    <deviceName>Biocetal R2 250g</deviceName>
    <manufacturerName>ROKO SP. Z O.O.</manufacturerName>
    <manufacturerSrn>PL-MF-000050171</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BR2 250</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:01:11.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901421261092</udiDi>
    <basicUdiDi>B-05901421261092</basicUdiDi>
    <tradeName>Biocetal R2 500g</tradeName>
    <deviceName>Biocetal R2 500g</deviceName>
    <manufacturerName>ROKO SP. Z O.O.</manufacturerName>
    <manufacturerSrn>PL-MF-000050171</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BR2 500</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:01:07.547Z</lastUpdated>
  </row>
  <row>
    <udiDi>05901421261085</udiDi>
    <basicUdiDi>B-05901421261085</basicUdiDi>
    <tradeName>Biocetal R1 500g</tradeName>
    <deviceName>Biocetal R1 500g</deviceName>
    <manufacturerName>ROKO SP. Z O.O.</manufacturerName>
    <manufacturerSrn>PL-MF-000050171</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010699</emdnCode>
    <emdnDescription>MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BR1 500</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T20:01:06.758Z</lastUpdated>
  </row>
</eudamedExport>