<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <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>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>
  </row>
  <row>
    <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>08056304454294</udiDi>
    <basicUdiDi>B-08056304454294</basicUdiDi>
    <tradeName>PX 1-5B</tradeName>
    <deviceName>PX 1-5B</deviceName>
    <manufacturerName>Esaote S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000019024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>120000078</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:26:52.653Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056304452948</udiDi>
    <basicUdiDi>B-08056304452948</basicUdiDi>
    <tradeName>PA250</tradeName>
    <deviceName>PA250</deviceName>
    <manufacturerName>Esaote S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000019024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>120000032</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:23:20.411Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056304452009</udiDi>
    <basicUdiDi>B-08056304452009</basicUdiDi>
    <tradeName>PA230E</tradeName>
    <deviceName>PA230E</deviceName>
    <manufacturerName>Esaote S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000019024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>9600165000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:22:29.098Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056304451903</udiDi>
    <basicUdiDi>B-08056304451903</basicUdiDi>
    <tradeName>PA023E</tradeName>
    <deviceName>PA023E</deviceName>
    <manufacturerName>Esaote S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000019024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>9600153000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:22:14.684Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056304451897</udiDi>
    <basicUdiDi>B-08056304451897</basicUdiDi>
    <tradeName>PA122E</tradeName>
    <deviceName>PA122E</deviceName>
    <manufacturerName>Esaote S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000019024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>9600152000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:22:13.884Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056304451880</udiDi>
    <basicUdiDi>B-08056304451880</basicUdiDi>
    <tradeName>PA121E</tradeName>
    <deviceName>PA121E</deviceName>
    <manufacturerName>Esaote S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000019024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>9600151000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:22:12.283Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056304451798</udiDi>
    <basicUdiDi>B-08056304451798</basicUdiDi>
    <tradeName>SP3630</tradeName>
    <deviceName>SP3630</deviceName>
    <manufacturerName>Esaote S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000019024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>122001400</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:22:07.506Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056304451545</udiDi>
    <basicUdiDi>B-08056304451545</basicUdiDi>
    <tradeName>SP2442</tradeName>
    <deviceName>SP2442</deviceName>
    <manufacturerName>Esaote S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000019024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>121200600</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:21:18.594Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056304451323</udiDi>
    <basicUdiDi>B-08056304451323</basicUdiDi>
    <tradeName>P 5-13</tradeName>
    <deviceName>P 5-13</deviceName>
    <manufacturerName>Esaote S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000019024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>120000022</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:21:04.185Z</lastUpdated>
  </row>
  <row>
    <udiDi>08056304451309</udiDi>
    <basicUdiDi>B-08056304451309</basicUdiDi>
    <tradeName>P 3-11</tradeName>
    <deviceName>P 3-11</deviceName>
    <manufacturerName>Esaote S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000019024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></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>120000001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T18:21:03.379Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517111793</udiDi>
    <basicUdiDi>B-00841517111793</basicUdiDi>
    <tradeName>P10xp/8-4 MHz</tradeName>
    <deviceName>TRANSDUCER, P10XP/8-4 MHZ</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>MDD</legislation>
    <emdnCode>Z110402010301</emdnCode>
    <emdnDescription>TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P17780-21A</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:44:25.841Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517111731</udiDi>
    <basicUdiDi>B-00841517111731</basicUdiDi>
    <tradeName>P21xp/5-1 MHz</tradeName>
    <deviceName>TRANSDUCER, P21XP/5-1 MHZ</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>MDD</legislation>
    <emdnCode>Z110402010301</emdnCode>
    <emdnDescription>TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P14563-21A</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:44:17.041Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517110994</udiDi>
    <basicUdiDi>B-00841517110994</basicUdiDi>
    <tradeName>P21x/5-1 MHz</tradeName>
    <deviceName>TRANSDUCER, P21X/5-1 MHZ</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>MDD</legislation>
    <emdnCode>Z110402010301</emdnCode>
    <emdnDescription>TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P24511-02</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:43:59.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517110215</udiDi>
    <basicUdiDi>B-00841517110215</basicUdiDi>
    <tradeName>P11-3</tradeName>
    <deviceName>TRANSDUCER, P11-3</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>MDD</legislation>
    <emdnCode>Z110402010301</emdnCode>
    <emdnDescription>TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>P32613-01</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:43:46.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>00841517109530</udiDi>
    <basicUdiDi>B-00841517109530</basicUdiDi>
    <tradeName>rP19xp/5-1 MH</tradeName>
    <deviceName>TRANSDUCER, RP19XP/5-1 MHZ</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>MDD</legislation>
    <emdnCode>Z110402010301</emdnCode>
    <emdnDescription>TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P22557-11</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-05T04:42:49.749Z</lastUpdated>
  </row>
</eudamedExport>