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<eudamedExport entity="devices">
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    <basicUdiDi>00894912002623L2</basicUdiDi>
    <tradeName>Single Use Doppler Probe, VDP-8</tradeName>
    <deviceName>Single Use Doppler probe, VDP-8</deviceName>
    <manufacturerName>Koven Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000000948</manufacturerSrn>
    <authorisedRepresentativeName>Atlantico Systems, Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000208</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040299</emdnCode>
    <emdnDescription>ULTRASOUND PROBES – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VDP-8</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:40:15.580Z</lastUpdated>
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  <row>
    <udiDi>00894912002609</udiDi>
    <basicUdiDi>00894912002609L8</basicUdiDi>
    <tradeName>Single Use Doppler Probe, NDP-20</tradeName>
    <deviceName>Single Use Doppler probe, NDP-20</deviceName>
    <manufacturerName>Koven Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000000948</manufacturerSrn>
    <authorisedRepresentativeName>Atlantico Systems, Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000208</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040299</emdnCode>
    <emdnDescription>ULTRASOUND PROBES – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NDP-20</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:40:14.773Z</lastUpdated>
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    <udiDi>00894912002593</udiDi>
    <basicUdiDi>00894912002593LJ</basicUdiDi>
    <tradeName>Single Use Doppler Probe, NDP-10</tradeName>
    <deviceName>Single Use Doppler probe, NDP-10</deviceName>
    <manufacturerName>Koven Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000000948</manufacturerSrn>
    <authorisedRepresentativeName>Atlantico Systems, Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000000208</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040299</emdnCode>
    <emdnDescription>ULTRASOUND PROBES – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NDP-10</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:40:13.975Z</lastUpdated>
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    <udiDi>00841517107697</udiDi>
    <basicUdiDi>008415171C103S3</basicUdiDi>
    <tradeName>C10-3</tradeName>
    <deviceName>TRANSDUCER, C10-3</deviceName>
    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000001075</manufacturerSrn>
    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110402010201</emdnCode>
    <emdnDescription>CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES  (CONVEX–ARRAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P23117-20A</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-15T19:25:30.680Z</lastUpdated>
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  <row>
    <udiDi>08809476810142</udiDi>
    <basicUdiDi>B-08809476810142</basicUdiDi>
    <tradeName>L6-24-D</tradeName>
    <deviceName>Medical Ultrasound Transducer</deviceName>
    <manufacturerName>HUMANSCAN Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000039737</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010101</emdnCode>
    <emdnDescription>TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5833059</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:57:25.742Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809476810128</udiDi>
    <basicUdiDi>B-08809476810128</basicUdiDi>
    <tradeName>P8D</tradeName>
    <deviceName>Medical Ultrasound Transducer</deviceName>
    <manufacturerName>HUMANSCAN Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000039737</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010101</emdnCode>
    <emdnDescription>TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5504447</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:57:24.946Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809476810111</udiDi>
    <basicUdiDi>B-08809476810111</basicUdiDi>
    <tradeName>S2-5-D</tradeName>
    <deviceName>Medical Ultrasound Transducer</deviceName>
    <manufacturerName>HUMANSCAN Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000039737</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</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>5721641</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:57:24.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809476810104</udiDi>
    <basicUdiDi>B-08809476810104</basicUdiDi>
    <tradeName>S1-4-D</tradeName>
    <deviceName>Medical Ultrasound Transducer</deviceName>
    <manufacturerName>HUMANSCAN Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000039737</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</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>5498609</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:57:20.140Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809476810098</udiDi>
    <basicUdiDi>B-08809476810098</basicUdiDi>
    <tradeName>3Sp-D</tradeName>
    <deviceName>Medical Ultrasound Transducer</deviceName>
    <manufacturerName>HUMANSCAN Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000039737</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</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>KTZ280293</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:57:19.335Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809476810081</udiDi>
    <basicUdiDi>B-08809476810081</basicUdiDi>
    <tradeName>L3-9i-RS</tradeName>
    <deviceName>Medical Ultrasound Transducer</deviceName>
    <manufacturerName>HUMANSCAN Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000039737</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010101</emdnCode>
    <emdnDescription>TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5721640</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:57:18.531Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809476810074</udiDi>
    <basicUdiDi>B-08809476810074</basicUdiDi>
    <tradeName>L3-9i-D</tradeName>
    <deviceName>Medical Ultrasound Transducer</deviceName>
    <manufacturerName>HUMANSCAN Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000039737</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010101</emdnCode>
    <emdnDescription>TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5491310</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:57:17.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809476810067</udiDi>
    <basicUdiDi>B-08809476810067</basicUdiDi>
    <tradeName>C2-7VN-D</tradeName>
    <deviceName>Medical Ultrasound Transducer</deviceName>
    <manufacturerName>HUMANSCAN Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000039737</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010201</emdnCode>
    <emdnDescription>CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES  (CONVEX–ARRAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5505701</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:57:13.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809476810050</udiDi>
    <basicUdiDi>B-08809476810050</basicUdiDi>
    <tradeName>C2-7-D-LC</tradeName>
    <deviceName>Medical Ultrasound Transducer</deviceName>
    <manufacturerName>HUMANSCAN Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000039737</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010201</emdnCode>
    <emdnDescription>CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES  (CONVEX–ARRAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5505702</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:57:12.931Z</lastUpdated>
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  <row>
    <udiDi>08809476810043</udiDi>
    <basicUdiDi>B-08809476810043</basicUdiDi>
    <tradeName>C2-7-D</tradeName>
    <deviceName>Medical Ultrasound Transducer</deviceName>
    <manufacturerName>HUMANSCAN Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000039737</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110402010201</emdnCode>
    <emdnDescription>CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES  (CONVEX–ARRAY)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5505700</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:57:12.147Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809476810036</udiDi>
    <basicUdiDi>B-08809476810036</basicUdiDi>
    <tradeName>S1-5-D</tradeName>
    <deviceName>Medical Ultrasound Transducer</deviceName>
    <manufacturerName>HUMANSCAN Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000039737</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</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>5438302-2</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:57:11.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809476810029</udiDi>
    <basicUdiDi>B-08809476810029</basicUdiDi>
    <tradeName>5Sp</tradeName>
    <deviceName>Medical Ultrasound Transducer</deviceName>
    <manufacturerName>HUMANSCAN Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000039737</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</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>5327197-2</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:57:07.332Z</lastUpdated>
  </row>
  <row>
    <udiDi>08809476810012</udiDi>
    <basicUdiDi>B-08809476810012</basicUdiDi>
    <tradeName>M5S-D</tradeName>
    <deviceName>Medical Ultrasound Transducer</deviceName>
    <manufacturerName>HUMANSCAN Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000039737</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</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>GE-R3MIX</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:57:06.524Z</lastUpdated>
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    <udiDi>08809476810005</udiDi>
    <basicUdiDi>B-08809476810005</basicUdiDi>
    <tradeName>3Sp</tradeName>
    <deviceName>Medical Ultrasound Transducer</deviceName>
    <manufacturerName>HUMANSCAN Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000039737</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</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>5327196-2</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:57:05.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>00884838061354</udiDi>
    <basicUdiDi>0884838BM428T4</basicUdiDi>
    <tradeName>Transducer D5cwc</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Philips Ultrasound LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002237</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040299</emdnCode>
    <emdnDescription>ULTRASOUND PROBES – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>989605412062</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:47:57.394Z</lastUpdated>
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  <row>
    <udiDi>00884838061361</udiDi>
    <basicUdiDi>0884838BM428T4</basicUdiDi>
    <tradeName>Transducer D2tcd</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Philips Ultrasound LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002237</manufacturerSrn>
    <authorisedRepresentativeName>Philips Medical Systems Nederland B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001422</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040299</emdnCode>
    <emdnDescription>ULTRASOUND PROBES – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>989605412102</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:47:57.362Z</lastUpdated>
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