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    <tradeName>04745010564307</tradeName>
    <deviceName>ECG Caliper</deviceName>
    <manufacturerName>1M4 OÜ</manufacturerName>
    <manufacturerSrn>EE-MF-000040367</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020180</emdnCode>
    <emdnDescription>CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>10028.00</reference>
    <placedOnMarketCountry>Estonia</placedOnMarketCountry>
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    <udiDi>04745010564314</udiDi>
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    <tradeName>04745010564314</tradeName>
    <deviceName>ECG Ruler</deviceName>
    <manufacturerName>1M4 OÜ</manufacturerName>
    <manufacturerSrn>EE-MF-000040367</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>09351351001163</udiDi>
    <basicUdiDi>B-09351351001163</basicUdiDi>
    <tradeName>Khelix Quadpolar Fixed Electrophysiology Catheter</tradeName>
    <deviceName>Khelix Quadpolar Fixed Electrophysiology Catheter [5SSF-ANN-4A555]</deviceName>
    <manufacturerName>CathRx Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000002757</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>5SSF-ANN-4A555</reference>
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    <udiDi>09351351001156</udiDi>
    <basicUdiDi>B-09351351001156</basicUdiDi>
    <tradeName>Khelix Duodecapolar Steerable Electrophysiology Catheter</tradeName>
    <deviceName>Khelix Duodecapolar Steerable Electrophysiology Catheter [SS2-R0U-20A6282]</deviceName>
    <manufacturerName>CathRx Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000002757</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C02010403</emdnCode>
    <emdnDescription>ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, ADJUSTABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS2-R0U-20A6282</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T00:59:15.849Z</lastUpdated>
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    <udiDi>09351351000050</udiDi>
    <basicUdiDi>B-09351351000050</basicUdiDi>
    <tradeName>Khelix Decapolar Steerable Electrophysiology Catheter</tradeName>
    <deviceName>Khelix Decapolar Steerable Electrophysiology Catheter [SS1-F0U-10A6252]</deviceName>
    <manufacturerName>CathRx Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000002757</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C02010403</emdnCode>
    <emdnDescription>ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, ADJUSTABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS1-F0U-10A6252</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T00:59:12.625Z</lastUpdated>
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    <udiDi>09351351000043</udiDi>
    <basicUdiDi>B-09351351000043</basicUdiDi>
    <tradeName>Khelix Decapolar Steerable Electrophysiology Catheter</tradeName>
    <deviceName>Khelix Decapolar Steerable Electrophysiology Catheter [SS1-D0U-10A6252]</deviceName>
    <manufacturerName>CathRx Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000002757</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C02010403</emdnCode>
    <emdnDescription>ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, ADJUSTABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS1-D0U-10A6252</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-23T00:59:11.861Z</lastUpdated>
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    <udiDi>09351351000357</udiDi>
    <basicUdiDi>B-09351351000357</basicUdiDi>
    <tradeName>Khelix Decapolar Steerable Electrophysiology Catheter</tradeName>
    <deviceName>Khelix Decapolar Steerable Electrophysiology Catheter [SS1-G0U-10A6252]</deviceName>
    <manufacturerName>CathRx Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000002757</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C02010403</emdnCode>
    <emdnDescription>ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, ADJUSTABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS1-G0U-10A6252</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-20T03:42:28.279Z</lastUpdated>
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    <udiDi>09351351000111</udiDi>
    <basicUdiDi>B-09351351000111</basicUdiDi>
    <tradeName>Khelix Duodecapolar Variable Loop Steerable Electrophysiology Catheter</tradeName>
    <deviceName>Khelix Duodecapolar Variable Loop Steerable Electrophysiology Catheter [SC2-B2515U-20P7262]</deviceName>
    <manufacturerName>CathRx Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000002757</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C02010403</emdnCode>
    <emdnDescription>ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, ADJUSTABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC2-B2515U-20P7262</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:55:28.988Z</lastUpdated>
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    <udiDi>09351351000081</udiDi>
    <basicUdiDi>B-09351351000081</basicUdiDi>
    <tradeName>Khelix Decapolar Fixed Loop Steerable Electrophysiology Catheter</tradeName>
    <deviceName>Khelix Decapolar Fixed Loop Steerable Electrophysiology Catheter [SC1-B20U-10P7666]</deviceName>
    <manufacturerName>CathRx Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000002757</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C02010403</emdnCode>
    <emdnDescription>ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, ADJUSTABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC1-B20U-10P7666</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:55:23.982Z</lastUpdated>
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    <udiDi>09351351000074</udiDi>
    <basicUdiDi>B-09351351000074</basicUdiDi>
    <tradeName>Khelix Decapolar Fixed Loop Steerable Electrophysiology Catheter</tradeName>
    <deviceName>Khelix Decapolar Fixed Loop Steerable Electrophysiology Catheter [SC1-B15U-10P7555]</deviceName>
    <manufacturerName>CathRx Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000002757</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C02010403</emdnCode>
    <emdnDescription>ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, ADJUSTABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC1-B15U-10P7555</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-17T20:55:23.941Z</lastUpdated>
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    <udiDi>09351351000135</udiDi>
    <basicUdiDi>B-09351351000135</basicUdiDi>
    <tradeName>Khelix Diagnostic Extension Cable 20pin</tradeName>
    <deviceName>Khelix Diagnostic Extension Cable 20Pin</deviceName>
    <manufacturerName>CathRx Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000002757</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020199</emdnCode>
    <emdnDescription>CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>X-D20</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T22:10:38.766Z</lastUpdated>
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    <udiDi>09351351000128</udiDi>
    <basicUdiDi>B-09351351000128</basicUdiDi>
    <tradeName>Khelix Diagnostic Extension Cable 10pin</tradeName>
    <deviceName>Khelix Diagnostic Extension Cable 10Pin</deviceName>
    <manufacturerName>CathRx Ltd</manufacturerName>
    <manufacturerSrn>AU-MF-000002757</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C020199</emdnCode>
    <emdnDescription>CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>X-D10</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T22:10:37.993Z</lastUpdated>
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    <udiDi>00857042007401</udiDi>
    <basicUdiDi>0857042007ACQMAPCATHNW</basicUdiDi>
    <tradeName>AcQMap 3D Imaging and Mapping Catheter</tradeName>
    <deviceName>AcQMap 3D Imaging and Mapping Catheter</deviceName>
    <manufacturerName>Acutus Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019413</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020105</emdnCode>
    <emdnDescription>NON-CONVENTIONAL MAPPING (CONTACT AND NON-CONTACT) THREE-DIMENSIONAL DIAGNOSTIC CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900009</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:41:41.610Z</lastUpdated>
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    <udiDi>00854277008203</udiDi>
    <basicUdiDi>0854277008ADXXX42</basicUdiDi>
    <tradeName>Advantage-MR™ EP Recorder/Stimulator</tradeName>
    <deviceName>Advantage-MR™ EP Recorder/Stimulator System</deviceName>
    <manufacturerName>Imricor Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017310</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020199</emdnCode>
    <emdnDescription>CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD900</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:40:03.855Z</lastUpdated>
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    <udiDi>00854277008197</udiDi>
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    <tradeName>NorthStar Mapping System</tradeName>
    <deviceName>NorthStar Mapping System</deviceName>
    <manufacturerName>Imricor Medical Systems, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000017310</manufacturerSrn>
    <authorisedRepresentativeName>MedR-AR Services B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000120</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MAP01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:40:01.453Z</lastUpdated>
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    <udiDi>00850298007096</udiDi>
    <basicUdiDi>0850298007099H</basicUdiDi>
    <tradeName>00850298007096</tradeName>
    <deviceName>Monitoring Lead Wires for EMG Monitoring 60" Leads Set of 2</deviceName>
    <manufacturerName>Somatics, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000011550</manufacturerSrn>
    <authorisedRepresentativeName>FBI Medizintechnik GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000009421</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C02010401</emdnCode>
    <emdnDescription>ARRHYTHMOLOGY MULTIPOLAR DIAGNOSTIC CATHETERS, CONVENTIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ELDS-BR</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:32:25.172Z</lastUpdated>
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    <udiDi>10846835000665</udiDi>
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    <tradeName>REFSTAR with QWIKPATCH External Reference Patch</tradeName>
    <deviceName>CARTO 3 System/
REFSTAR with QWIKPATCH/
REFSTAR PLUS with QWIKPATCH External Reference Patch</deviceName>
    <manufacturerName>Biosense Webster, Inc</manufacturerName>
    <manufacturerSrn>US-MF-000014219</manufacturerSrn>
    <authorisedRepresentativeName>Biosense Webster A Division of Johnson &amp; Johnson Medical NV/SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000012231</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020105</emdnCode>
    <emdnDescription>NON-CONVENTIONAL MAPPING (CONTACT AND NON-CONTACT) THREE-DIMENSIONAL DIAGNOSTIC CATHETERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>34N01M</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:05:47.223Z</lastUpdated>
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    <tradeName>Affera™</tradeName>
    <deviceName>Affera Integrated Mapping System</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006050</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020199</emdnCode>
    <emdnDescription>CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFR-00016</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:09:07.114Z</lastUpdated>
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    <tradeName>N/A</tradeName>
    <deviceName>Impedance Localization Patch Kit</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
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    <emdnCode>C020180</emdnCode>
    <emdnDescription>CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFR-00015</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:08:54.095Z</lastUpdated>
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    <tradeName>Affera™</tradeName>
    <deviceName>Affera Mapping System</deviceName>
    <manufacturerName>Medtronic, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000019977</manufacturerSrn>
    <authorisedRepresentativeName>Medtronic B.V.</authorisedRepresentativeName>
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    <emdnDescription>CARDIAC ELECTROPHYSIOLOGY AND MAPPING DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFR-00003</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:08:49.391Z</lastUpdated>
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