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    <deviceName></deviceName>
    <manufacturerName>HOYA Technosurgical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000045863</manufacturerSrn>
    <authorisedRepresentativeName>HOYA Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004416</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2037604</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:01:27.487Z</lastUpdated>
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    <udiDi>04582428429879</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L25S(S)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Technosurgical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000045863</manufacturerSrn>
    <authorisedRepresentativeName>HOYA Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004416</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2037600</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:01:26.608Z</lastUpdated>
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    <udiDi>04582428429862</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L25S(K)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Technosurgical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000045863</manufacturerSrn>
    <authorisedRepresentativeName>HOYA Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004416</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2037599</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:01:25.782Z</lastUpdated>
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    <udiDi>04582428429855</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L25S(B)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Technosurgical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000045863</manufacturerSrn>
    <authorisedRepresentativeName>HOYA Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004416</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2037601</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:01:23.893Z</lastUpdated>
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    <udiDi>04582428429848</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L20S(S)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Technosurgical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000045863</manufacturerSrn>
    <authorisedRepresentativeName>HOYA Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004416</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2037597</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:01:23.014Z</lastUpdated>
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    <udiDi>04582428429831</udiDi>
    <basicUdiDi>4582428-TSU-0001QW</basicUdiDi>
    <tradeName>PENTAX PRISMVUE NF2 L20S(K)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>HOYA Technosurgical Corporation</manufacturerName>
    <manufacturerSrn>JP-MF-000045863</manufacturerSrn>
    <authorisedRepresentativeName>HOYA Holdings B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000004416</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2037596</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-06-18T08:01:21.216Z</lastUpdated>
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    <udiDi>06975132953941</udiDi>
    <basicUdiDi>697259778IB005LP</basicUdiDi>
    <tradeName>Brilliance</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>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5080180</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:39:23.767Z</lastUpdated>
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    <udiDi>06975132953958</udiDi>
    <basicUdiDi>697259778IB005LP</basicUdiDi>
    <tradeName>Brilliance</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>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5080182</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:39:23.748Z</lastUpdated>
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    <udiDi>06975132953965</udiDi>
    <basicUdiDi>697259778IB005LP</basicUdiDi>
    <tradeName>Brilliance</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>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5080184</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:39:23.728Z</lastUpdated>
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    <udiDi>06975132953972</udiDi>
    <basicUdiDi>697259778IB005LP</basicUdiDi>
    <tradeName>Brilliance</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>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5080186</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:39:23.712Z</lastUpdated>
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    <udiDi>06975132953989</udiDi>
    <basicUdiDi>697259778IB005LP</basicUdiDi>
    <tradeName>Brilliance</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>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5080188</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:39:23.700Z</lastUpdated>
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    <udiDi>06975132953996</udiDi>
    <basicUdiDi>697259778IB005LP</basicUdiDi>
    <tradeName>Brilliance</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>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5080190</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:39:23.689Z</lastUpdated>
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    <udiDi>06975132954009</udiDi>
    <basicUdiDi>697259778IB005LP</basicUdiDi>
    <tradeName>Brilliance</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>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5080192</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:39:23.674Z</lastUpdated>
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    <udiDi>06975132954016</udiDi>
    <basicUdiDi>697259778IB005LP</basicUdiDi>
    <tradeName>Brilliance</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>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5080194</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:39:23.661Z</lastUpdated>
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    <udiDi>06975132954023</udiDi>
    <basicUdiDi>697259778IB005LP</basicUdiDi>
    <tradeName>Brilliance</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>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5080196</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:39:23.645Z</lastUpdated>
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    <udiDi>06975132954030</udiDi>
    <basicUdiDi>697259778IB005LP</basicUdiDi>
    <tradeName>Brilliance</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>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5080198</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:39:23.634Z</lastUpdated>
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    <udiDi>06975132954047</udiDi>
    <basicUdiDi>697259778IB005LP</basicUdiDi>
    <tradeName>Brilliance</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>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5080200</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:39:23.619Z</lastUpdated>
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    <basicUdiDi>697259778IB005LP</basicUdiDi>
    <tradeName>Brilliance</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>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5080206</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:39:23.597Z</lastUpdated>
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    <udiDi>06975132954061</udiDi>
    <basicUdiDi>697259778IB005LP</basicUdiDi>
    <tradeName>Brilliance</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>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5080208</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:39:23.568Z</lastUpdated>
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    <udiDi>06975132954078</udiDi>
    <basicUdiDi>697259778IB005LP</basicUdiDi>
    <tradeName>Brilliance</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>UNKNOWN</legislation>
    <emdnCode>L0316</emdnCode>
    <emdnDescription>HELMETS AND BINOCULAR GLASSES FOR SURGEONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5080210</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T09:39:23.555Z</lastUpdated>
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