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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>
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    <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>
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    <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>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
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    <deviceStatus>AB pazarı için değil</deviceStatus>
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    <lastUpdated>2026-07-20T02:06:36.570Z</lastUpdated>
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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>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
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    <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>
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    <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>
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    <udiDi>18859299112623</udiDi>
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    <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>
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    <udiDi>18859299112654</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml 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>487230N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.441Z</lastUpdated>
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    <udiDi>18859299112661</udiDi>
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    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml 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>487240N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.412Z</lastUpdated>
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    <udiDi>18859299112678</udiDi>
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    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 2-14ml/h Bolus 2ml Refill 60 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>487250N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.381Z</lastUpdated>
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    <udiDi>18859299112685</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 2-14ml/h Bolus 1ml 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>487260N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.339Z</lastUpdated>
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    <udiDi>18859299112692</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml 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>487270N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.308Z</lastUpdated>
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    <udiDi>18859299112708</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Plus-PainBloc-Variable Flow with Bolus Volume 400ml flow 2-14ml/h Bolus 2ml Refill 15 min Bifurcate 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>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>487280N</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:36.256Z</lastUpdated>
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    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Pump 120-10-12h</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>480257</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:07.448Z</lastUpdated>
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    <udiDi>18859299129034</udiDi>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <tradeName>SMARTeZ Pump 100-200-30m</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>481017</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-20T02:06:07.402Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Henan Tuoren Medical Device Co., Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000013924</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP C III GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000011196</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>NCBI27515L50</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:06.902Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Henan Tuoren Medical Device Co., Ltd</manufacturerName>
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    <authorisedRepresentativeName>MedNet EC-REP C III GmbH</authorisedRepresentativeName>
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    <emdnCode>A05010101</emdnCode>
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    <reference>NCBI20020L50</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:06.875Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Henan Tuoren Medical Device Co., Ltd</manufacturerName>
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    <authorisedRepresentativeName>MedNet EC-REP C III GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
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    <reference>NCBI06010L50</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:06.818Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Henan Tuoren Medical Device Co., Ltd</manufacturerName>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCBI06020L50</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:06.792Z</lastUpdated>
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    <manufacturerName>Henan Tuoren Medical Device Co., Ltd</manufacturerName>
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    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010101</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCBI10020L50</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
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    <manufacturerName>Henan Tuoren Medical Device Co., Ltd</manufacturerName>
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    <legislation>UNKNOWN</legislation>
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    <reference>NCBI10040L50</reference>
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    <legislation>UNKNOWN</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>NCBI27520L50</reference>
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    <lastUpdated>2026-07-18T10:58:06.707Z</lastUpdated>
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