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    <tradeName>ViVi® HELMET²⁵</tradeName>
    <deviceName>ViVi® HELMET²⁵</deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>L0316</emdnCode>
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    <lastUpdated>2026-07-31T21:30:52.251Z</lastUpdated>
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    <tradeName>ViVi® HELMET</tradeName>
    <deviceName>ViVi® HELMET</deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
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    <reference>80100</reference>
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    <udiDi>08809906010005</udiDi>
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    <tradeName>NK TTL LOUPE x2.5</tradeName>
    <deviceName>Gx2.5 NK00</deviceName>
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    <manufacturerSrn>KR-MF-000039665</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>17.NKvision_Catalog_Medipia_2025</reference>
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    <lastUpdated>2026-07-31T21:02:37.988Z</lastUpdated>
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    <udiDi>05744000230047</udiDi>
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    <tradeName>ExamVision Loupe System Galilean Essential 2.5x</tradeName>
    <deviceName>ExamVision Loupe System</deviceName>
    <manufacturerName>ExamVision A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000032397</manufacturerSrn>
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    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESS25BIO</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:37:47.337Z</lastUpdated>
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    <udiDi>05744000230030</udiDi>
    <basicUdiDi>574400023EVLoupeXD</basicUdiDi>
    <tradeName>Essential 2.5x</tradeName>
    <deviceName>ExamVision Loupe System</deviceName>
    <manufacturerName>ExamVision A/S</manufacturerName>
    <manufacturerSrn>DK-MF-000032397</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>ESS25</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-31T09:31:56.544Z</lastUpdated>
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    <udiDi>06941877828905</udiDi>
    <basicUdiDi>697259778IB016LU</basicUdiDi>
    <tradeName>Brilliance Elite</tradeName>
    <deviceName>Surgical Binocular Loupes</deviceName>
    <manufacturerName>Changzhou Sifary Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010405</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5088164</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-07-29T20:08:03.536Z</lastUpdated>
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    <basicUdiDi>697259778IB016LU</basicUdiDi>
    <tradeName>Brilliance Elite</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changzhou Sifary Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010405</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5088167</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:53:10.125Z</lastUpdated>
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    <tradeName>Brilliance Elite</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changzhou Sifary Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010405</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5088170</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:53:09.197Z</lastUpdated>
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    <basicUdiDi>697259778IB016LU</basicUdiDi>
    <tradeName>Brilliance Elite</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changzhou Sifary Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010405</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5088173</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:52:58.993Z</lastUpdated>
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    <udiDi>06941877828943</udiDi>
    <basicUdiDi>697259778IB016LU</basicUdiDi>
    <tradeName>Brilliance Elite</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changzhou Sifary Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010405</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5088176</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:52:54.120Z</lastUpdated>
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    <udiDi>06941877828950</udiDi>
    <basicUdiDi>697259778IB016LU</basicUdiDi>
    <tradeName>Brilliance Elite</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changzhou Sifary Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010405</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5088179</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:52:45.482Z</lastUpdated>
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    <udiDi>06941877828967</udiDi>
    <basicUdiDi>697259778IB016LU</basicUdiDi>
    <tradeName>Brilliance Elite</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changzhou Sifary Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010405</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5088182</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:52:44.846Z</lastUpdated>
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    <udiDi>06941877828974</udiDi>
    <basicUdiDi>697259778IB016LU</basicUdiDi>
    <tradeName>Brilliance Elite</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Changzhou Sifary Medical Technology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000010405</manufacturerSrn>
    <authorisedRepresentativeName>Caretechion GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005946</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5088185</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:52:44.390Z</lastUpdated>
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    <udiDi>04046955082674</udiDi>
    <basicUdiDi>40392390000019803B</basicUdiDi>
    <tradeName>Aesculap</tradeName>
    <deviceName>Polarisation glasses</deviceName>
    <manufacturerName>Aesculap AG</manufacturerName>
    <manufacturerSrn>DE-MF-000005504</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PV621</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-28T12:41:21.447Z</lastUpdated>
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    <basicUdiDi>9009607HELMET80XXXHC</basicUdiDi>
    <tradeName>ViVi® HELMET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80100 Rev-S3</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:28:00.371Z</lastUpdated>
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    <basicUdiDi>9009607HELMET80XXXHC</basicUdiDi>
    <tradeName>ViVi® HELMET</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
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    <lastUpdated>2026-07-23T17:28:00.358Z</lastUpdated>
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    <basicUdiDi>9009607HELMET80XXXHC</basicUdiDi>
    <tradeName>ViVi® HELMET HPL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80130</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:28:00.343Z</lastUpdated>
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    <udiDi>09009607801332</udiDi>
    <basicUdiDi>9009607HELMET80XXXHC</basicUdiDi>
    <tradeName>ViVi® HELMET HPL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>ViVi® HELMET HPL</tradeName>
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    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
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    <basicUdiDi>9009607HELMET81XXXHK</basicUdiDi>
    <tradeName>ViVi® HELMET²⁵ XL</tradeName>
    <deviceName></deviceName>
    <manufacturerName>THI Total Healthcare Innovation GmbH</manufacturerName>
    <manufacturerSrn>AT-MF-000044495</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>81100XL</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-23T17:27:49.104Z</lastUpdated>
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