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    <tradeName>PROGRAMMING DEVICE FOR SPHERA PRO PROGRAMMABLE VALVE REG-PRO</tradeName>
    <deviceName>PROGRAMMING DEVICE FOR SPHERA PRO PROGRAMMABLE VALVE REG-PRO</deviceName>
    <manufacturerName>HP BIOPROTESES LTDA</manufacturerName>
    <manufacturerSrn>BR-MF-000048434</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>REG-PRO</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:12:35.084Z</lastUpdated>
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    <udiDi>04260125713865</udiDi>
    <basicUdiDi>426012571NKT1ST53</basicUdiDi>
    <tradeName>Ventricular Drainage Catheter 8F</tradeName>
    <deviceName>Ventricular Drainage Catheter Standard</deviceName>
    <manufacturerName>Spiegelberg GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000000008</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>N010399</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NKT.1.08.01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:20:22.622Z</lastUpdated>
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    <udiDi>04260125713728</udiDi>
    <basicUdiDi>426012571ICP1STXB</basicUdiDi>
    <tradeName>Ventricular Probe 8F</tradeName>
    <deviceName>Ventricular Probe Standard</deviceName>
    <manufacturerName>Spiegelberg GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000000008</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>N010399</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ICP.1.08.01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T19:20:04.951Z</lastUpdated>
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    <udiDi>04260125714008</udiDi>
    <basicUdiDi>426012571NKT1ST53</basicUdiDi>
    <tradeName>Ventricular Drainage Catheter 12F with Cranial Bolt</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spiegelberg GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000000008</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>N010399</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NKT.1.12.02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T20:50:00.497Z</lastUpdated>
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    <udiDi>04260125713995</udiDi>
    <basicUdiDi>426012571NKT1ST53</basicUdiDi>
    <tradeName>Ventricular Drainage Catheter 12F</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spiegelberg GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000000008</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>N010399</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NKT.1.12.01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T20:49:59.601Z</lastUpdated>
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    <udiDi>04260125713896</udiDi>
    <basicUdiDi>426012571NKT1ST53</basicUdiDi>
    <tradeName>Ventricular Drainage Catheter 10F with Cranial Bolt</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spiegelberg GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000000008</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>N010399</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NKT.1.10.02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T20:49:58.707Z</lastUpdated>
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    <udiDi>04260125713889</udiDi>
    <basicUdiDi>426012571NKT1ST53</basicUdiDi>
    <tradeName>Ventricular Drainage Catheter 10F</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spiegelberg GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000000008</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>N010399</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NKT.1.10.01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T20:49:57.847Z</lastUpdated>
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    <udiDi>04260125713872</udiDi>
    <basicUdiDi>426012571NKT1ST53</basicUdiDi>
    <tradeName>Ventricular Drainage Catheter 8F with Cranial Bolt</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spiegelberg GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000000008</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>N010399</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NKT.1.08.02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T20:49:56.935Z</lastUpdated>
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    <udiDi>04260125713018</udiDi>
    <basicUdiDi>B-04260125713018</basicUdiDi>
    <tradeName>Ventricular Drainage Catheter with Cranial Bolt 10F</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spiegelberg GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000000008</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>N010399</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVD30.034.01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T20:49:43.398Z</lastUpdated>
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    <udiDi>04260125713001</udiDi>
    <basicUdiDi>B-04260125713001</basicUdiDi>
    <tradeName>Ventricular Drainage Catheter with Cranial Bolt 8F</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spiegelberg GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000000008</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>N010399</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVD30.014.01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T20:49:42.482Z</lastUpdated>
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  <row>
    <udiDi>04260125710291</udiDi>
    <basicUdiDi>B-04260125710291</basicUdiDi>
    <tradeName>Ventricular Drainage Catheter 10F</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spiegelberg GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000000008</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>N010399</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVD30.030.01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T20:49:32.575Z</lastUpdated>
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    <udiDi>04260125710185</udiDi>
    <basicUdiDi>B-04260125710185</basicUdiDi>
    <tradeName>Silverline® Ventricular Drainage Catheter 8F</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spiegelberg GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000000008</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>N010399</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVD30.010.02</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T20:49:30.787Z</lastUpdated>
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    <udiDi>04260125710178</udiDi>
    <basicUdiDi>B-04260125710178</basicUdiDi>
    <tradeName>Ventricular Drainage Catheter 8F</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spiegelberg GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000000008</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>N010399</emdnCode>
    <emdnDescription>INTRACRANIAL DRAINAGE DEVICES AND KITS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>EVD30.010.01</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-17T20:49:29.891Z</lastUpdated>
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