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<eudamedExport entity="devices">
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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>
  </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>
  </row>
  <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>
  </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>08809449090113</udiDi>
    <basicUdiDi>B-08809449090113</basicUdiDi>
    <tradeName>KYBS Kyphoplasty Balloon System</tradeName>
    <deviceName>KYBS Kyphoplasty Balloon System</deviceName>
    <manufacturerName>OK Medinet Korea</manufacturerName>
    <manufacturerSrn>KR-MF-000033858</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>K010301</emdnCode>
    <emdnDescription>SPINAL PERCUTANEOUS PLASTIC DEVICES WITH BALLOON</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>OKB1115, OTKS, OKMB</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-10T11:10:08.729Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800142100895</udiDi>
    <basicUdiDi>B-08800142100895</basicUdiDi>
    <tradeName>TERA HARZ</tradeName>
    <deviceName>TERA HARZ</deviceName>
    <manufacturerName>Graphy Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000012692</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0102050199</emdnCode>
    <emdnDescription>DENTISTRY RESINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:56:08.697Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800142100888</udiDi>
    <basicUdiDi>B-08800142100888</basicUdiDi>
    <tradeName>TERA HARZ</tradeName>
    <deviceName>TERA HARZ</deviceName>
    <manufacturerName>Graphy Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000012692</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0102050199</emdnCode>
    <emdnDescription>DENTISTRY RESINS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:56:07.109Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800142100871</udiDi>
    <basicUdiDi>B-08800142100871</basicUdiDi>
    <tradeName>TERA HARZ</tradeName>
    <deviceName>TERA HARZ</deviceName>
    <manufacturerName>Graphy Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000012692</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0102050199</emdnCode>
    <emdnDescription>DENTISTRY RESINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:56:04.709Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800142100864</udiDi>
    <basicUdiDi>B-08800142100864</basicUdiDi>
    <tradeName>TERA HARZ</tradeName>
    <deviceName>TERA HARZ</deviceName>
    <manufacturerName>Graphy Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000012692</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0102050199</emdnCode>
    <emdnDescription>DENTISTRY RESINS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:56:03.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800142100857</udiDi>
    <basicUdiDi>B-08800142100857</basicUdiDi>
    <tradeName>TERA HARZ</tradeName>
    <deviceName>TERA HARZ</deviceName>
    <manufacturerName>Graphy Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000012692</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0102050199</emdnCode>
    <emdnDescription>DENTISTRY RESINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:56:02.390Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800142100840</udiDi>
    <basicUdiDi>B-08800142100840</basicUdiDi>
    <tradeName>TERA HARZ</tradeName>
    <deviceName>TERA HARZ</deviceName>
    <manufacturerName>Graphy Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000012692</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0102050199</emdnCode>
    <emdnDescription>DENTISTRY RESINS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:55:59.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800142100833</udiDi>
    <basicUdiDi>B-08800142100833</basicUdiDi>
    <tradeName>TERA HARZ</tradeName>
    <deviceName>TERA HARZ</deviceName>
    <manufacturerName>Graphy Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000012692</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0102050199</emdnCode>
    <emdnDescription>DENTISTRY RESINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:55:57.513Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800142100826</udiDi>
    <basicUdiDi>B-08800142100826</basicUdiDi>
    <tradeName>TERA HARZ</tradeName>
    <deviceName>TERA HARZ</deviceName>
    <manufacturerName>Graphy Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000012692</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0102050199</emdnCode>
    <emdnDescription>DENTISTRY RESINS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:55:55.895Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800142100819</udiDi>
    <basicUdiDi>B-08800142100819</basicUdiDi>
    <tradeName>TERA HARZ</tradeName>
    <deviceName>TERA HARZ</deviceName>
    <manufacturerName>Graphy Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000012692</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0102050199</emdnCode>
    <emdnDescription>DENTISTRY RESINS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:55:55.092Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800142100802</udiDi>
    <basicUdiDi>B-08800142100802</basicUdiDi>
    <tradeName>TERA HARZ</tradeName>
    <deviceName>TERA HARZ</deviceName>
    <manufacturerName>Graphy Inc.</manufacturerName>
    <manufacturerSrn>KR-MF-000012692</manufacturerSrn>
    <authorisedRepresentativeName>SMB EUROPE SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000011981</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0102050199</emdnCode>
    <emdnDescription>DENTISTRY RESINS - OTHER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>none</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-10T04:55:53.494Z</lastUpdated>
  </row>
</eudamedExport>