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    <basicUdiDi>B-08809489920005</basicUdiDi>
    <tradeName>SONON 300C</tradeName>
    <deviceName>SONON Ultrasound Imaging System</deviceName>
    <manufacturerName>Healcerion Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000029153</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040106</emdnCode>
    <emdnDescription>HANDHELD ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HC-BR-SON-EN</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T12:13:20.410Z</lastUpdated>
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    <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>
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    <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>
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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>
    <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>
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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>
    <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>
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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>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>
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    <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>
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    <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>
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    <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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    <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>
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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>
    <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>
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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>08800076600119</udiDi>
    <basicUdiDi>B-08800076600119</basicUdiDi>
    <tradeName>Sonovation1L, SOFRA1L, SonoInfra1L, Dr.SAFE, ACUFRIEND, ACUGUIDE,ACUWARY, AcuViz Pocket, Sono Cloud 1, eZono1000, eZ1L</tradeName>
    <deviceName>SC1 Handheld ultrasound imaging system</deviceName>
    <manufacturerName>FCU Co., Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000015583</manufacturerSrn>
    <authorisedRepresentativeName>eZono AG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007197</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z11040106</emdnCode>
    <emdnDescription>HANDHELD ULTRASOUND SCANNERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:22:40.287Z</lastUpdated>
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    <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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    <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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    <udiDi>00884838061385</udiDi>
    <basicUdiDi>0884838BM428T4</basicUdiDi>
    <tradeName>Transducer C5-2, Variant 2</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>989605389242</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:47:57.339Z</lastUpdated>
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    <udiDi>00884838061408</udiDi>
    <basicUdiDi>0884838BM428T4</basicUdiDi>
    <tradeName>Transducer L12-4, Variant 8</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>989605389262</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T20:47:57.298Z</lastUpdated>
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