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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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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>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <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>
    <basicUdiDi>88592991B001U4</basicUdiDi>
    <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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    <udiDi>18859299129027</udiDi>
    <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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  <row>
    <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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    <udiDi>06938016775602</udiDi>
    <basicUdiDi>693801670000FU</basicUdiDi>
    <tradeName>06938016775602</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Royal Fornia Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008628</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010201</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - VARIABLE FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WZ-6522-R02</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:29.283Z</lastUpdated>
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    <udiDi>06938016775770</udiDi>
    <basicUdiDi>693801670000FU</basicUdiDi>
    <tradeName>06938016775770</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Royal Fornia Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008628</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010201</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - FIXED FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WZ-6622-2</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:29.256Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Royal Fornia Medical Equipment Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000008628</manufacturerSrn>
    <authorisedRepresentativeName>Shanghai International Holding Corp. GmbH(Europe)</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000001</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>A05010201</emdnCode>
    <emdnDescription>ELASTOMERIC SYSTEMS - VARIABLE FLOW W/O ADDITIONAL BOLUS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WZ-6522-0R05</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-18T10:58:29.240Z</lastUpdated>
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