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    <tradeName>ToxiSeal Vial Adaptor with External Flip Balloon (DMA Compatible) 13 mm Vial Concave</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0704</emdnCode>
    <emdnDescription>SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>420720ST</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T12:53:19.111Z</lastUpdated>
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    <udiDi>18859299119455</udiDi>
    <basicUdiDi>88592991B014UD</basicUdiDi>
    <tradeName>ToxiSeal Vial Adaptor with External Flip Balloon (DMA Compatible) 20 mm Vial Concave</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>
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    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>420730ST</reference>
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    <lastUpdated>2026-06-21T12:53:19.093Z</lastUpdated>
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    <udiDi>18859299119462</udiDi>
    <basicUdiDi>88592991B014UD</basicUdiDi>
    <tradeName>ToxiSeal Vial Adaptor with External Flip Balloon (DMA Compatible) 28 mm Vial Concave</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>
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    <emdnDescription>SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>420740ST</reference>
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    <lastUpdated>2026-06-21T12:53:19.073Z</lastUpdated>
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    <udiDi>18859299119479</udiDi>
    <basicUdiDi>88592991B014UD</basicUdiDi>
    <tradeName>ProSeal Non-Vented Bag Spike with ProSeal Injection Site (DMA Compatible)</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 I</riskClass>
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    <emdnCode>A0704</emdnCode>
    <emdnDescription>SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>423840ST</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T12:53:19.055Z</lastUpdated>
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    <udiDi>18859299119486</udiDi>
    <basicUdiDi>88592991B014UD</basicUdiDi>
    <tradeName>ProSeal Injection Site-Extended MLL (DMA Compatible)</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0704</emdnCode>
    <emdnDescription>SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>422140ST</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T12:53:19.034Z</lastUpdated>
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    <udiDi>18859299119509</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ C100-2-50h (Transparent with ChemoSafe)</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>MDR 2017/745</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>484010TC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T12:53:19.009Z</lastUpdated>
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    <tradeName>SMARTeZ C120-5-24h (Transparent with ChemoSafe)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>484290TC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T12:53:18.988Z</lastUpdated>
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    <udiDi>18859299119547</udiDi>
    <basicUdiDi>88592991B014UD</basicUdiDi>
    <tradeName>ToxiSeal Vial Adaptor 20 - 28 mm Vial</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
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    <emdnDescription>SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>420660ST</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T12:53:18.968Z</lastUpdated>
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    <udiDi>18859299119554</udiDi>
    <basicUdiDi>88592991B014UD</basicUdiDi>
    <tradeName>ToxiSeal Vial Adaptor with External Balloon 20 - 28mm Vial</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 I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A0704</emdnCode>
    <emdnDescription>SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>420670ST</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T12:53:18.947Z</lastUpdated>
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    <udiDi>18859299119578</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-General Infusion 100-100-60m with Hanger Cap</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>MDR 2017/745</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>471040HC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T12:53:18.916Z</lastUpdated>
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    <udiDi>18859299119585</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 1-7ml/h Bolus 5ml Refill 30 min Single Hanger Cap</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
    <manufacturerSrn>TH-MF-000012102</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>487430HC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-21T12:53:18.897Z</lastUpdated>
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    <udiDi>18859299119592</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 1-7ml/h Bolus 5ml Refill 30 min Single Hanger Cap&amp;NRFit</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
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    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
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    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>487430HCN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 1-7ml/h Bolus 5ml Refill 30 min Single NRFit</tradeName>
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    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
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    <deviceStatus>AB pazarı için değil</deviceStatus>
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    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 2-14ml/h Bolus 5ml Refill 60 min Single Hanger Cap</tradeName>
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    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
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    <deviceStatus>AB pazarı için değil</deviceStatus>
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    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 2-14ml/h Bolus 5ml Refill 60 min Single Hanger Cap&amp;NRFit</tradeName>
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    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
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    <deviceStatus>AB pazarı için değil</deviceStatus>
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    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 2-14ml/h Bolus 5 ml Refill 60 min Single NRFit</tradeName>
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    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
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    <deviceStatus>AB pazarı için değil</deviceStatus>
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    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 2-14ml/h Bolus 5ml Refill 30 min Single Hanger Cap</tradeName>
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    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
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    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>487450HC</reference>
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    <lastUpdated>2026-06-21T12:53:18.767Z</lastUpdated>
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    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 2-14ml/h Bolus 5ml Refill 30 min Single Hanger Cap&amp;NRFit</tradeName>
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    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
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    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>487450HCN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 2-14ml/h Bolus 5 ml Refill 30 min Single NRFit</tradeName>
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    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
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    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>487450N</reference>
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    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 600ml flow 1-7ml/h Bolus 5ml Refill 60 min Single Hanger Cap</tradeName>
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    <manufacturerName>Epic International (Thailand) Co., Ltd.</manufacturerName>
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    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>487460HC</reference>
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