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    <manufacturerName>Fujifilm Sonosite, Inc.</manufacturerName>
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    <authorisedRepresentativeName>Fujifilm Sonosite B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000046</authorisedRepresentativeSrn>
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    <reference>P29671-21</reference>
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    <manufacturerName>GE Medical Systems CO. Ltd</manufacturerName>
    <manufacturerSrn>CN-MF-000001856</manufacturerSrn>
    <authorisedRepresentativeName>GE Medical Systems SCS</authorisedRepresentativeName>
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    <reference>H48062AU</reference>
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    <manufacturerName>Siemens Medical Solutions USA Inc.</manufacturerName>
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    <authorisedRepresentativeName>Siemens Healthcare s.r.o.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SK-AR-000048444</authorisedRepresentativeSrn>
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    <reference>11291796</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:38:34.815Z</lastUpdated>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <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>
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    <basicUdiDi>B-08056304451903</basicUdiDi>
    <tradeName>PA023E</tradeName>
    <deviceName>PA023E</deviceName>
    <manufacturerName>Esaote S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000019024</manufacturerSrn>
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    <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>
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    <basicUdiDi>B-08056304451897</basicUdiDi>
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    <manufacturerName>Esaote S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000019024</manufacturerSrn>
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    <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>
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    <basicUdiDi>B-08056304451880</basicUdiDi>
    <tradeName>PA121E</tradeName>
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    <manufacturerName>Esaote S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000019024</manufacturerSrn>
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    <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>
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    <basicUdiDi>B-08056304451798</basicUdiDi>
    <tradeName>SP3630</tradeName>
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    <manufacturerName>Esaote S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000019024</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>122001400</reference>
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    <emdnDescription>TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>121200600</reference>
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    <lastUpdated>2026-07-07T18:21:18.594Z</lastUpdated>
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    <emdnDescription>TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>120000022</reference>
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    <emdnCode>Z110402010301</emdnCode>
    <emdnDescription>TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL</emdnDescription>
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