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    <tradeName>Leadwires</tradeName>
    <deviceName>RADIOLUCENT ECG LEADWIRES</deviceName>
    <manufacturerName>Advantage Medical Electronics LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008512</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KT-RTR5739</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:44:24.419Z</lastUpdated>
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    <basicUdiDi>B-00849593018234</basicUdiDi>
    <tradeName>LEADWIRE</tradeName>
    <deviceName>RADIOLUCENT ECG LEADWIRES</deviceName>
    <manufacturerName>Advantage Medical Electronics LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008512</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020599</emdnCode>
    <emdnDescription>CARDIAC DIAGNOSTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KT-RTR5738</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:44:22.821Z</lastUpdated>
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    <udiDi>00849593018227</udiDi>
    <basicUdiDi>B-00849593018227</basicUdiDi>
    <tradeName>LEADWIRE</tradeName>
    <deviceName>RADIOLUCENT ECG LEADWIRES</deviceName>
    <manufacturerName>Advantage Medical Electronics LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008512</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020599</emdnCode>
    <emdnDescription>CARDIAC DIAGNOSTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KT-RTR5735</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:44:22.021Z</lastUpdated>
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    <udiDi>00849593018210</udiDi>
    <basicUdiDi>B-00849593018210</basicUdiDi>
    <tradeName>LEADWIRE</tradeName>
    <deviceName>RADIOLUCENT ECG LEADWIRES</deviceName>
    <manufacturerName>Advantage Medical Electronics LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008512</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KT-RTR5730</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:44:20.408Z</lastUpdated>
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    <udiDi>00849593018203</udiDi>
    <basicUdiDi>B-00849593018203</basicUdiDi>
    <tradeName>LEADWIRE</tradeName>
    <deviceName>RADIOLUCENT ECG LEADWIRES</deviceName>
    <manufacturerName>Advantage Medical Electronics LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008512</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020599</emdnCode>
    <emdnDescription>CARDIAC DIAGNOSTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KT-RTR5722</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:44:18.016Z</lastUpdated>
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    <udiDi>00849593018197</udiDi>
    <basicUdiDi>B-00849593018197</basicUdiDi>
    <tradeName>LEADWIRE</tradeName>
    <deviceName>RADIOLUCENT ECG LEADWIRES</deviceName>
    <manufacturerName>Advantage Medical Electronics LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008512</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KT-RTR5721</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:44:16.420Z</lastUpdated>
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    <udiDi>00849593018135</udiDi>
    <basicUdiDi>B-00849593018135</basicUdiDi>
    <tradeName>LEADWIRE</tradeName>
    <deviceName>RADIOLUCENT ECG LEADWIRES</deviceName>
    <manufacturerName>Advantage Medical Electronics LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008512</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020599</emdnCode>
    <emdnDescription>CARDIAC DIAGNOSTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KT-RTR5737</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:44:15.616Z</lastUpdated>
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    <udiDi>00849593018128</udiDi>
    <basicUdiDi>B-00849593018128</basicUdiDi>
    <tradeName>LEADWIRE</tradeName>
    <deviceName>RADIOLUCENT ECG LEADWIRES</deviceName>
    <manufacturerName>Advantage Medical Electronics LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008512</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KT-RTR5736</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:44:14.027Z</lastUpdated>
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    <udiDi>00849593018111</udiDi>
    <basicUdiDi>B-00849593018111</basicUdiDi>
    <tradeName>LEADWIRE</tradeName>
    <deviceName>RADIOLUCENT ECG LEADWIRES</deviceName>
    <manufacturerName>Advantage Medical Electronics LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008512</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KT-RTR5731</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:44:11.613Z</lastUpdated>
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    <udiDi>00849593018104</udiDi>
    <basicUdiDi>B-00849593018104</basicUdiDi>
    <tradeName>LEADWIRE</tradeName>
    <deviceName>RADIOLUCENT ECG LEADWIRES</deviceName>
    <manufacturerName>Advantage Medical Electronics LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008512</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12050380</emdnCode>
    <emdnDescription>ELECTROCARDIOGRAPHS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>KT-RTR5732</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T07:44:10.008Z</lastUpdated>
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