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    <tradeName>MEDLINECARE-2</tradeName>
    <deviceName>MEDLINECARE-2</deviceName>
    <manufacturerName>Medical Online Technology, S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000042216</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>MDD</legislation>
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    <reference>MEDLINECARE-2</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-07T22:05:34.325Z</lastUpdated>
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    <udiDi>03760124132076</udiDi>
    <basicUdiDi>B-03760124132076</basicUdiDi>
    <tradeName>PRESSIO® 2 ICP MONITOR</tradeName>
    <deviceName>Pressio 2 ICP Monitor</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
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    <reference>PSO-4000</reference>
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    <udiDi>03760124131772</udiDi>
    <basicUdiDi>B-03760124131772</basicUdiDi>
    <tradeName>PRESSIO® ICP &amp; ICT MONITORING KIT, VENTRICULAR TUNNELING</tradeName>
    <deviceName>PRESSIO® ICP &amp; ICT MONITORING KIT, VENTRICULAR TUNNELING</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>INTRACRANIAL PRESSURE MEASURING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSO-VTT</reference>
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    <lastUpdated>2026-07-05T18:31:59.894Z</lastUpdated>
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    <udiDi>03760124131765</udiDi>
    <basicUdiDi>B-03760124131765</basicUdiDi>
    <tradeName>PRESSIO® ICP &amp; ICT MONITORING KIT, PARENCHYMAL WITH BOLT</tradeName>
    <deviceName>PRESSIO® ICP &amp; ICT MONITORING KIT, PARENCHYMAL TUNNELING</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12039001</emdnCode>
    <emdnDescription>INTRACRANIAL PRESSURE MEASURING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSO-PTT</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:57.547Z</lastUpdated>
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    <udiDi>03760124131758</udiDi>
    <basicUdiDi>B-03760124131758</basicUdiDi>
    <tradeName>KIT PRESSIO® POUR MONITORING DE PRESSION ET DE TEMPÉRATURE INTRACRÂNIENNES, PARENCHYMATEUX À BOULON</tradeName>
    <deviceName>PRESSIO® ICP &amp; ICT MONITORING KIT, PARENCHYMAL WITH BOLT</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12039001</emdnCode>
    <emdnDescription>INTRACRANIAL PRESSURE MEASURING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSO-PBT</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:55.911Z</lastUpdated>
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    <udiDi>03760124131482</udiDi>
    <basicUdiDi>B-03760124131482</basicUdiDi>
    <tradeName>PRESSIO® MONITORING KIT, VENTRICULAR TUNNELING</tradeName>
    <deviceName>Pressio® Intracranial pressure monitoring Kit, ventricular tunnelling</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12039001</emdnCode>
    <emdnDescription>INTRACRANIAL PRESSURE MEASURING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSO-VT</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:31:27.026Z</lastUpdated>
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    <udiDi>03760124130782</udiDi>
    <basicUdiDi>B-03760124130782</basicUdiDi>
    <tradeName>PRESSIO® MONITORING KIT, PARENCHYMAL TUNNELING</tradeName>
    <deviceName>Pressio® Intracranial pressure monitoring Kit, parenchymal tunnelling</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12039001</emdnCode>
    <emdnDescription>INTRACRANIAL PRESSURE MEASURING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSO-PT</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:18.935Z</lastUpdated>
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    <udiDi>03760124130768</udiDi>
    <basicUdiDi>B-03760124130768</basicUdiDi>
    <tradeName>PRESSIO® ICP MONITORING KIT, PARENCHYMAL WITH BOLT</tradeName>
    <deviceName>Pressio® Intracranial pressure monitoring Kit, parenchymal with bolt</deviceName>
    <manufacturerName>SOPHYSA</manufacturerName>
    <manufacturerSrn>FR-MF-000002870</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12039001</emdnCode>
    <emdnDescription>INTRACRANIAL PRESSURE MEASURING SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PSO-PB</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T18:30:17.329Z</lastUpdated>
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    <udiDi>00884838099128</udiDi>
    <basicUdiDi>B-00884838099128</basicUdiDi>
    <tradeName>CareEvent</tradeName>
    <deviceName>CareEvent</deviceName>
    <manufacturerName>Philips Medical Systems</manufacturerName>
    <manufacturerSrn>US-MF-000002321</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12039082</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS - SOFTWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>866435</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T09:09:52.778Z</lastUpdated>
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    <udiDi>87206485600028</udiDi>
    <basicUdiDi>8720648560IEPSA9</basicUdiDi>
    <tradeName>87206485600028</tradeName>
    <deviceName>intelligent Esophageal Pressure System</deviceName>
    <manufacturerName>PulmoTech BV</manufacturerName>
    <manufacturerSrn>NL-MF-000013242</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12039099</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>C01-125-12-01</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:00:44.890Z</lastUpdated>
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    <udiDi>08437022861036</udiDi>
    <basicUdiDi>8437022861VP1BR</basicUdiDi>
    <tradeName>Vitio Platform</tradeName>
    <deviceName>Vitio Platform</deviceName>
    <manufacturerName>Vitio Medical S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000033548</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12039092</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>08437022861036</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:11:55.445Z</lastUpdated>
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    <udiDi>08059693592608</udiDi>
    <basicUdiDi>805969359THOLOMEUSJ7</basicUdiDi>
    <tradeName>THOLOMEUS</tradeName>
    <deviceName>THOLOMEUS</deviceName>
    <manufacturerName>Biotechmed S.r.l.</manufacturerName>
    <manufacturerSrn>IT-MF-000030231</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12039092</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Version 2.6.0</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T09:37:02.243Z</lastUpdated>
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    <udiDi>08057971620029</udiDi>
    <basicUdiDi>805797162PASCAL001JS</basicUdiDi>
    <tradeName>AMICOMED</tradeName>
    <deviceName>AMICOMED</deviceName>
    <manufacturerName>NEWEL HEALTH S.R.L.</manufacturerName>
    <manufacturerSrn>IT-MF-000028500</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12039092</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AMICOMED</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:53:08.984Z</lastUpdated>
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    <tradeName>Telemedicina&amp;DCP</tradeName>
    <deviceName>Telemedicina&amp;DCP</deviceName>
    <manufacturerName>Paginemediche srl SB</manufacturerName>
    <manufacturerSrn>IT-MF-000041045</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:32:46.580Z</lastUpdated>
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    <tradeName>PREVIA</tradeName>
    <deviceName>PREVIA</deviceName>
    <manufacturerName>WIRELESS SENSOR NETWORKS SRL</manufacturerName>
    <manufacturerSrn>IT-MF-000038940</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>Z12039099</emdnCode>
    <emdnDescription>VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2989285</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T08:21:17.167Z</lastUpdated>
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    <manufacturerName>AViTA Corporation</manufacturerName>
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    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>6NRXI-K</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-03T07:54:24.362Z</lastUpdated>
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    <manufacturerName>AViTA Corporation</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Arm Type Blood Pressure Monitor Cuff</tradeName>
    <deviceName></deviceName>
    <manufacturerName>AViTA Corporation</manufacturerName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>6COMI K</reference>
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    <lastUpdated>2026-07-03T07:54:23.934Z</lastUpdated>
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    <tradeName>Arm Type Blood Pressure Monitor Cuff</tradeName>
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    <manufacturerName>AViTA Corporation</manufacturerName>
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    <emdnDescription>VVARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6COUI-K</reference>
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    <tradeName>HOWDY BABY</tradeName>
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    <manufacturerName>ComfTech</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>VARIOUS INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CMF23EL01</reference>
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    <lastUpdated>2026-07-03T06:48:35.474Z</lastUpdated>
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