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    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow Volume 600ml flow rate 2-14 ml/h</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>486080</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:45.386Z</lastUpdated>
  </row>
  <row>
    <udiDi>18859299106097</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow Volume 400ml flow rate Dual 1-7 ml/h</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>486090</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:45.353Z</lastUpdated>
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    <udiDi>18859299106103</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow Volume 400ml flow rate Dual 2-14 ml/h</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>486100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:45.324Z</lastUpdated>
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    <udiDi>18859299106110</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow Volume 600ml flow rate Dual 1-7 ml/h</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>486110</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:45.295Z</lastUpdated>
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  <row>
    <udiDi>18859299106127</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow Volume 600ml flow rate 2-14 ml/h, Bifurcated</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>486120</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:45.272Z</lastUpdated>
  </row>
  <row>
    <udiDi>18859299106134</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow Volume 600ml flow rate Dual 2-14 ml/h</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>486130</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:45.244Z</lastUpdated>
  </row>
  <row>
    <udiDi>18859299106141</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow Volume 800ml flow rate 1-7 ml/h</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>486140</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:45.223Z</lastUpdated>
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  <row>
    <udiDi>18859299106158</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow Volume 800ml flow rate 2-14 ml/h</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>486150</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:45.206Z</lastUpdated>
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    <udiDi>18859299106165</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus PainBloc-Variable Flow Volume 800 ml flow rate Dual 1-7 ml/h</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>486160</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:45.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>18859299106172</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow Volume 800ml flow rate Dual 2-14 ml</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>486170</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:45.156Z</lastUpdated>
  </row>
  <row>
    <udiDi>18859299107018</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 100ml flow 1-7ml/h Bolus 2ml Refill 60 min Single</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>487010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:45.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>18859299107025</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 270ml flow 1-7ml/h Bolus 2ml Refill 30 min Single</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>487020</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:45.104Z</lastUpdated>
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  <row>
    <udiDi>18859299107032</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 1-7ml/h Bolus 2ml Refill 60 min Bifurcate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>487030</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:45.080Z</lastUpdated>
  </row>
  <row>
    <udiDi>18859299107063</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 100ml flow 1-7ml/h Bolus 2ml Refill 15 min Single</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>487060</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:45.051Z</lastUpdated>
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  <row>
    <udiDi>18859299107070</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 100ml flow 1-7ml/h Bolus 2ml Refill 15 min Bifurcate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>487070</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:45.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>18859299107100</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 100ml flow 2-14ml/h Bolus 2ml Refill 15 min Single</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>487100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:45.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>18859299107117</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 100ml flow 2-14ml/h Bolus 2ml Refill 15 min Bifurcate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>487110</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:44.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>18859299107148</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 270ml flow 1-7ml/h Bolus 2ml Refill 15 min Single</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>487140</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:44.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>18859299107155</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 270ml flow 1-7ml/h Bolus 2ml Refill 15 min Bifurcate</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>487150</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:44.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>18859299107179</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 270ml flow 2-14ml/h Bolus 2ml Refill 15 min Single</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>487170</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:44.916Z</lastUpdated>
  </row>
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