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    <deviceName></deviceName>
    <manufacturerName>CardioFocus</manufacturerName>
    <manufacturerSrn>US-MF-000008457</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>C020399</emdnCode>
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    <reference>GTI-00036</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:55:24.291Z</lastUpdated>
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    <basicUdiDi>0850033727GTI-00045B9</basicUdiDi>
    <tradeName>ECG Trunk Cable</tradeName>
    <deviceName>CENTAURI Cable Adapter</deviceName>
    <manufacturerName>Galvanize Therapeutics, Inc.</manufacturerName>
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    <authorisedRepresentativeName>Galvanize Therapeutics Germany GmbH</authorisedRepresentativeName>
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    <legislation>MDR 2017/745</legislation>
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    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>GTI-00045</reference>
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    <basicUdiDi>0850033727GTI-00038BC</basicUdiDi>
    <tradeName>Compatibility Cable, BW ThermoCool ST</tradeName>
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    <manufacturerName>Galvanize Therapeutics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000012701</manufacturerSrn>
    <authorisedRepresentativeName>Galvanize Therapeutics Germany GmbH</authorisedRepresentativeName>
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    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>GTI-00038</reference>
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    <tradeName>CENTAURI Connect</tradeName>
    <deviceName>CENTAURI Connect</deviceName>
    <manufacturerName>Galvanize Therapeutics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000012701</manufacturerSrn>
    <authorisedRepresentativeName>Galvanize Therapeutics Germany GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>GTI-00022-03</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:22:24.045Z</lastUpdated>
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    <udiDi>00850033727012</udiDi>
    <basicUdiDi>0850033727GTI-00021-01HW</basicUdiDi>
    <tradeName>CENTAURI Generator</tradeName>
    <deviceName>CENTAURI Generator</deviceName>
    <manufacturerName>Galvanize Therapeutics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000012701</manufacturerSrn>
    <authorisedRepresentativeName>Galvanize Therapeutics Germany GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000035678</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>GTI-00021-01</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:22:23.245Z</lastUpdated>
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    <udiDi>00850033727005</udiDi>
    <basicUdiDi>0850033727GTI-00036B8</basicUdiDi>
    <tradeName>WAVE 1 Activation Materials</tradeName>
    <deviceName>WAVE 1 Activation Materials</deviceName>
    <manufacturerName>Galvanize Therapeutics, Inc.</manufacturerName>
    <manufacturerSrn>US-PR-000036570</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GTI-00036</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T03:22:19.240Z</lastUpdated>
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    <basicUdiDi>081008718CABLEVS</basicUdiDi>
    <tradeName>FARASTAR™</tradeName>
    <deviceName>FARAPULSE PFA Capital Equipment Components</deviceName>
    <manufacturerName>Farapulse Inc</manufacturerName>
    <manufacturerSrn>US-MF-000017969</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000006507</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>61M404</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:53:09.395Z</lastUpdated>
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    <basicUdiDi>081008718FARAGYE</basicUdiDi>
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    <deviceName>FARAPULSE PFA Capital Equipment</deviceName>
    <manufacturerName>Farapulse Inc</manufacturerName>
    <manufacturerSrn>US-MF-000017969</manufacturerSrn>
    <authorisedRepresentativeName>ICON (LR) Limited</authorisedRepresentativeName>
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    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>61M407</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T00:53:04.582Z</lastUpdated>
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    <tradeName>FARASTAR™</tradeName>
    <deviceName>FARASTAR Cable Set</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M004PF61M499D</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:02:49.318Z</lastUpdated>
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    <basicUdiDi>01915060000000000000536NE</basicUdiDi>
    <tradeName>FARAPULSE PFA Capital Equipment</tradeName>
    <deviceName>FARAPULSE PFA Capital Equipment</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M004PFCE61M401</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:02:42.117Z</lastUpdated>
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    <tradeName>FARASTAR™</tradeName>
    <deviceName>FARAPULSE PFA Capital Equipment Components</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M004PF61M409</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:02:40.293Z</lastUpdated>
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    <basicUdiDi>01915060000000000000670NK</basicUdiDi>
    <tradeName>FARASTAR™</tradeName>
    <deviceName>FARASTAR Catheter Connection Cables</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M004PF41M424</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T20:02:39.860Z</lastUpdated>
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    <udiDi>08714729992691</udiDi>
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    <tradeName>SMARTFREEZE™</tradeName>
    <deviceName>Smartfreeze Cryo-Console</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003840</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M004CRBS4000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:59:16.166Z</lastUpdated>
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    <tradeName>IntellaTip MiFi™</tradeName>
    <deviceName>IntellaTip MiFi Filter Module</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
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    <emdnCode>C020399</emdnCode>
    <emdnDescription>CARDIAC TISSUE ABLATION DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0041212D0</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:58:25.061Z</lastUpdated>
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    <tradeName>IntellaNav™</tradeName>
    <deviceName>IntellaNav Cable</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000004702</manufacturerSrn>
    <authorisedRepresentativeName>Boston Scientific Limited</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>M004RARC010</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:58:23.400Z</lastUpdated>
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    <tradeName>IntellaTip MiFi™</tradeName>
    <deviceName>IntellaTip MiFi OI CABLE</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0046210</reference>
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    <lastUpdated>2026-07-15T19:58:21.082Z</lastUpdated>
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    <tradeName>IntellaTip MiFi™</tradeName>
    <deviceName>IntellaTip MiFi XP CABLE</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0046200</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:58:19.466Z</lastUpdated>
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    <tradeName>IntellaTip MiFi™</tradeName>
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    <manufacturerName>Boston Scientific Corporation</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>M00436360</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:58:18.225Z</lastUpdated>
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    <tradeName>Blazer™</tradeName>
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    <manufacturerName>Boston Scientific Corporation</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>M0046910</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:58:07.485Z</lastUpdated>
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    <tradeName>08714729270010</tradeName>
    <deviceName>Recording System EGM Cable</deviceName>
    <manufacturerName>Boston Scientific Corporation</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>M004653S0</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:57:11.575Z</lastUpdated>
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