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    <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>486020HCN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:37.052Z</lastUpdated>
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    <udiDi>18859299112371</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow Volume 270ml flow rate 1-7 ml/h with Hanger Cap&amp;NRFit</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>
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    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>486030HCN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:37.025Z</lastUpdated>
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    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow Volume 270ml flow rate 2-14 ml/h with Hanger Cap&amp;NRFit</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>486040HCN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.995Z</lastUpdated>
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    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow Volume 400ml flow rate 1-7 ml/h with Hanger Cap&amp;NRFit</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>486050HCN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.963Z</lastUpdated>
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    <udiDi>18859299112401</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow Volume 400ml flow rate 2-14 ml/h with Hanger Cap&amp;NRFit</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>486060HCN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.937Z</lastUpdated>
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    <udiDi>18859299112418</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow Volume 600ml flow rate 1-7 ml/h with Hanger Cap&amp;NRFit</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>486070HCN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.904Z</lastUpdated>
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    <udiDi>18859299112425</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow Volume 600ml flow rate 2-14 ml/h with Hanger Cap&amp;NRFit</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>486080HCN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.876Z</lastUpdated>
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    <udiDi>18859299112432</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 100ml flow 1-7ml/h Bolus 2ml Refill 60min Single NRFit</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>487010N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.848Z</lastUpdated>
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    <udiDi>18859299112449</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 270ml flow 1-7ml/h Bolus 2ml Refill 30 min Single NRFit</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>487020N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.817Z</lastUpdated>
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    <udiDi>18859299112456</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 1-7ml/h Bolus 2ml Refill 60 min Bifurcate NRFit</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>487030N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.787Z</lastUpdated>
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    <udiDi>18859299112487</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 100ml flow 1-7ml/h Bolus 2ml Refill 15min Single NRFit</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>487060N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.759Z</lastUpdated>
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    <udiDi>18859299112494</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 100ml flow 1-7ml/h Bolus 2ml Refill 15min Bifurcate &amp;NRFit</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>487070N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.727Z</lastUpdated>
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    <udiDi>18859299112524</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 100ml flow 2-14ml/h Bolus 2ml Refill 15 min Single NRFit</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>487100N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.693Z</lastUpdated>
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    <udiDi>18859299112531</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 100ml flow 2-14ml/h Bolus 2ml Refill 15 min Bifurcate NRFit</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>487110N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.664Z</lastUpdated>
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    <udiDi>18859299112562</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 270ml flow 1-7ml/h Bolus 2ml Refill 15 min Single NRFit</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>487140N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.640Z</lastUpdated>
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    <udiDi>18859299112579</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 270ml flow 1-7ml/h Bolus 2ml Refill 15 min Bifurcate NRFit</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>487150N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.610Z</lastUpdated>
  </row>
  <row>
    <udiDi>18859299112593</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 270ml flow 2-14ml/h Bolus 2ml Refill 15 min Single NRFit</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>487170N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.570Z</lastUpdated>
  </row>
  <row>
    <udiDi>18859299112609</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 270ml flow 2-14ml/h Bolus 2ml Refill 15 min Bifurcate NRFit</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>487180N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>18859299112616</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 270ml flow 2-14ml/h Bolus 2ml Refill 30 min Single NRFit</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>487190N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.500Z</lastUpdated>
  </row>
  <row>
    <udiDi>18859299112623</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 270ml flow 2-14ml/h Bolus 2ml Refill 30 min Bifurcate NRFit</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>487200N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.474Z</lastUpdated>
  </row>
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