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<eudamedExport entity="devices">
  <row>
    <udiDi>04719890770424</udiDi>
    <basicUdiDi>B-04719890770424</basicUdiDi>
    <tradeName>AL6E124</tradeName>
    <deviceName>Broadsound AL6E124 Diagnostic Ultrasound Transducer Assembly</deviceName>
    <manufacturerName>Broadsound Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000018523</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1104020201</emdnCode>
    <emdnDescription>ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>795AL6E124U50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:59:27.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719890770295</udiDi>
    <basicUdiDi>B-04719890770295</basicUdiDi>
    <tradeName>AL3P299</tradeName>
    <deviceName>Broadsound AL3P299 Diagnostic Ultrasound Transducer Assembly</deviceName>
    <manufacturerName>Broadsound Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000018523</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010301</emdnCode>
    <emdnDescription>TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>795AL3P299U50</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:59:26.454Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719890770233</udiDi>
    <basicUdiDi>B-04719890770233</basicUdiDi>
    <tradeName>AL7L24B</tradeName>
    <deviceName>Broadsound AL7L24B Diagnostic Ultrasound Transducer Assembly</deviceName>
    <manufacturerName>Broadsound Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000018523</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010101</emdnCode>
    <emdnDescription>TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>795AL7L24BU50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:59:11.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719890770196</udiDi>
    <basicUdiDi>B-04719890770196</basicUdiDi>
    <tradeName>AL8L413</tradeName>
    <deviceName>Broadsound AL8L413 Diagnostic Ultrasound Transducer Assembly</deviceName>
    <manufacturerName>Broadsound Corporation</manufacturerName>
    <manufacturerSrn>TW-MF-000018523</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010101</emdnCode>
    <emdnDescription>TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>795AL8L413U50</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:59:09.487Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719882150050</udiDi>
    <basicUdiDi>B-04719882150050</basicUdiDi>
    <tradeName>Leltek</tradeName>
    <deviceName>Diagnostic Ultrasound Imaging System</deviceName>
    <manufacturerName>Leltek Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000013923</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040106</emdnCode>
    <emdnDescription>HANDHELD ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LU700C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-02T10:56:46.911Z</lastUpdated>
  </row>
  <row>
    <udiDi>04718018530025</udiDi>
    <basicUdiDi>B-04718018530025</basicUdiDi>
    <tradeName>DELTA</tradeName>
    <deviceName>High Voltage Generator DMP-100R</deviceName>
    <manufacturerName>Delta Electronics, Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000003930</manufacturerSrn>
    <authorisedRepresentativeName>Delta Electronics (Netherlands) B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001692</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039011</emdnCode>
    <emdnDescription>HIGH VOLTAGE X-RAY GENERATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMG-50KAX BC</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:57:07.859Z</lastUpdated>
  </row>
  <row>
    <udiDi>04718018530018</udiDi>
    <basicUdiDi>B-04718018530018</basicUdiDi>
    <tradeName>DELTA</tradeName>
    <deviceName>High Voltage Generator DMP-100R</deviceName>
    <manufacturerName>Delta Electronics, Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000003930</manufacturerSrn>
    <authorisedRepresentativeName>Delta Electronics (Netherlands) B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001692</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039011</emdnCode>
    <emdnDescription>HIGH VOLTAGE X-RAY GENERATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMG-40KAX BC</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:57:07.063Z</lastUpdated>
  </row>
  <row>
    <udiDi>04718018530001</udiDi>
    <basicUdiDi>B-04718018530001</basicUdiDi>
    <tradeName>DELTA</tradeName>
    <deviceName>High Voltage Generator DMP-100R</deviceName>
    <manufacturerName>Delta Electronics, Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000003930</manufacturerSrn>
    <authorisedRepresentativeName>Delta Electronics (Netherlands) B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001692</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039011</emdnCode>
    <emdnDescription>HIGH VOLTAGE X-RAY GENERATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DMG-40KAX AC</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:57:06.261Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713909450635</udiDi>
    <basicUdiDi>B-04713909450635</basicUdiDi>
    <tradeName>Sensor RXS 1000</tradeName>
    <deviceName>Intraoral Digital X-Ray Sensor</deviceName>
    <manufacturerName>Rolence Enterprise Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000024483</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039016</emdnCode>
    <emdnDescription>MOBILE RADIOGRAPHIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1501</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:51:06.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>04713909450628</udiDi>
    <basicUdiDi>B-04713909450628</basicUdiDi>
    <tradeName>Protable X-Ray XR-01</tradeName>
    <deviceName>Portable X-Ray</deviceName>
    <manufacturerName>Rolence Enterprise Inc.</manufacturerName>
    <manufacturerSrn>TW-MF-000024483</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039016</emdnCode>
    <emdnDescription>MOBILE RADIOGRAPHIC UNITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1500</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-08-02T09:51:04.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>04630193910716</udiDi>
    <basicUdiDi>B-04630193910716</basicUdiDi>
    <tradeName>DIARM MW</tradeName>
    <deviceName>Mobile DR Suitcase System</deviceName>
    <manufacturerName>MEDICAL TECHNOLOGIES Ltd</manufacturerName>
    <manufacturerSrn>RU-MF-000020612</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039099</emdnCode>
    <emdnDescription>VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>F0359E</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:58:31.194Z</lastUpdated>
  </row>
  <row>
    <udiDi>04560138482605</udiDi>
    <basicUdiDi>B-04560138482605</basicUdiDi>
    <tradeName>Angiography Contrast Delivery Systems PRESS DUO elite</tradeName>
    <deviceName>Angiography Contrast Delivery Systems PRESS DUO elite</deviceName>
    <manufacturerName>Nemoto Kyorindo Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000004827</manufacturerSrn>
    <authorisedRepresentativeName>Medicor International NV/SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000003308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039014</emdnCode>
    <emdnDescription>MULTIPLE CONTRAST AGENT INJECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Many</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:41:53.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>04560138482100</udiDi>
    <basicUdiDi>B-04560138482100</basicUdiDi>
    <tradeName>MR Contrast Delivery Systems SONIC SHOT 7</tradeName>
    <deviceName>MR Contrast Delivery Systems SONIC SHOT 7</deviceName>
    <manufacturerName>Nemoto Kyorindo Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000004827</manufacturerSrn>
    <authorisedRepresentativeName>Medicor International NV/SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000003308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039014</emdnCode>
    <emdnDescription>MULTIPLE CONTRAST AGENT INJECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SS70111</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:41:51.673Z</lastUpdated>
  </row>
  <row>
    <udiDi>04560138482001</udiDi>
    <basicUdiDi>B-04560138482001</basicUdiDi>
    <tradeName>CT Contrast Delivery Systems SmartShot alpha</tradeName>
    <deviceName>CT Contrast Delivery Systems SmartShot alpha</deviceName>
    <manufacturerName>Nemoto Kyorindo Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000004827</manufacturerSrn>
    <authorisedRepresentativeName>Medicor International NV/SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000003308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039014</emdnCode>
    <emdnDescription>MULTIPLE CONTRAST AGENT INJECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Many</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:41:49.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>04560138481707</udiDi>
    <basicUdiDi>B-04560138481707</basicUdiDi>
    <tradeName>CT Contrast Delivery Systems DUAL SHOT alpha7</tradeName>
    <deviceName>CT Contrast Delivery Systems DUAL SHOT alpha7</deviceName>
    <manufacturerName>Nemoto Kyorindo Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000004827</manufacturerSrn>
    <authorisedRepresentativeName>Medicor International NV/SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000003308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039014</emdnCode>
    <emdnDescription>MULTIPLE CONTRAST AGENT INJECTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Many</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:41:47.678Z</lastUpdated>
  </row>
  <row>
    <udiDi>04560138481301</udiDi>
    <basicUdiDi>B-04560138481301</basicUdiDi>
    <tradeName>Extravasation Sensors LD</tradeName>
    <deviceName>Extravasation Sensors LD</deviceName>
    <manufacturerName>Nemoto Kyorindo Co., Ltd.</manufacturerName>
    <manufacturerSrn>JP-MF-000004827</manufacturerSrn>
    <authorisedRepresentativeName>Medicor International NV/SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000003308</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11039080</emdnCode>
    <emdnDescription>VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - HARDWARE ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LD10110</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-02T07:41:46.876Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838067417</udiDi>
    <basicUdiDi>B-00884838067417</basicUdiDi>
    <tradeName>SENSE XL Torso Coil Posterior</tradeName>
    <deviceName>SENSE XL Torso Coil Posterior</deviceName>
    <manufacturerName>Invivo Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000002284</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1105018099</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>453530360823</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T17:49:43.429Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838067400</udiDi>
    <basicUdiDi>B-00884838067400</basicUdiDi>
    <tradeName>SENSE XL Torso Coil</tradeName>
    <deviceName>SENSE XL Torso Coil</deviceName>
    <manufacturerName>Invivo Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000002284</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1105018099</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>453530360653</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T17:49:42.638Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838067318</udiDi>
    <basicUdiDi>B-00884838067318</basicUdiDi>
    <tradeName>SENSE Shoulder Coil 1.5T</tradeName>
    <deviceName>SENSE Shoulder Coil 1.5T</deviceName>
    <manufacturerName>Invivo Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000002284</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1105018099</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>453530104125</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T17:49:38.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838067172</udiDi>
    <basicUdiDi>B-00884838067172</basicUdiDi>
    <tradeName>SENSE NV Coil 3.0T/16ch</tradeName>
    <deviceName>SENSE NV Coil 3.0T/16ch</deviceName>
    <manufacturerName>Invivo Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000002284</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1105018099</emdnCode>
    <emdnDescription>MAGNETIC RESONANCE (MR) SYSTEMS - HARDWARE ACCESSORIES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>453530077123</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T17:49:37.867Z</lastUpdated>
  </row>
</eudamedExport>