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    <basicUdiDi>59076961diamdentalbursHJ</basicUdiDi>
    <tradeName>Diamond dental burs</tradeName>
    <deviceName>Diamond dental burs</deviceName>
    <manufacturerName>"Verdent" spółka z ograniczoną odpowiedzialnością</manufacturerName>
    <manufacturerSrn>PL-MF-000024196</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>806.314.001.504.007</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T11:33:07.930Z</lastUpdated>
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  <row>
    <udiDi>04546951616762</udiDi>
    <basicUdiDi>4546951000017ZQ</basicUdiDi>
    <tradeName>MANI CARBIDE BURS - 8456RF</tradeName>
    <deviceName>MANI CARBIDE BURS</deviceName>
    <manufacturerName>MANI, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000017860</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:53:02.034Z</lastUpdated>
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  <row>
    <udiDi>04546951606220</udiDi>
    <basicUdiDi>4546951000018ZS</basicUdiDi>
    <tradeName>MANI DIA-BURS - WR-S31F</tradeName>
    <deviceName>MANI DIA-BURS</deviceName>
    <manufacturerName>MANI, INC.</manufacturerName>
    <manufacturerSrn>JP-MF-000017860</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>-</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:52:56.412Z</lastUpdated>
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    <udiDi>00813110023797</udiDi>
    <basicUdiDi>081311002LIJ9</basicUdiDi>
    <tradeName>00813110023797</tradeName>
    <deviceName>Latch Instrument</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-101-001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:50:55.334Z</lastUpdated>
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  <row>
    <udiDi>00810000524280</udiDi>
    <basicUdiDi>081000052HEDGEHOGVU</basicUdiDi>
    <tradeName>Hedgehog™</tradeName>
    <deviceName>HedgeHog Burs</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S497</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T16:46:54.155Z</lastUpdated>
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  <row>
    <udiDi>00810000524297</udiDi>
    <basicUdiDi>081000052HEDGEHOGVU</basicUdiDi>
    <tradeName>Hedgehog™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S498</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T09:09:39.834Z</lastUpdated>
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  <row>
    <udiDi>00810000524303</udiDi>
    <basicUdiDi>081000052HEDGEHOGVU</basicUdiDi>
    <tradeName>Hedgehog™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S499</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T09:09:39.807Z</lastUpdated>
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  <row>
    <udiDi>00810000524310</udiDi>
    <basicUdiDi>081000052HEDGEHOGVU</basicUdiDi>
    <tradeName>Hedgehog™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S500</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T09:09:39.786Z</lastUpdated>
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    <udiDi>00810000524327</udiDi>
    <basicUdiDi>081000052HEDGEHOGVU</basicUdiDi>
    <tradeName>Hedgehog™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S501</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T09:09:39.764Z</lastUpdated>
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    <udiDi>00810000524334</udiDi>
    <basicUdiDi>081000052HEDGEHOGVU</basicUdiDi>
    <tradeName>Hedgehog™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S502</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T09:09:39.738Z</lastUpdated>
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    <udiDi>00810000524341</udiDi>
    <basicUdiDi>081000052HEDGEHOGVU</basicUdiDi>
    <tradeName>Hedgehog™</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S503</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-28T09:09:39.721Z</lastUpdated>
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    <udiDi>00813110023803</udiDi>
    <basicUdiDi>081311002LIJ9</basicUdiDi>
    <tradeName>00813110023803</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-101-002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T10:19:03.747Z</lastUpdated>
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    <udiDi>00813110023940</udiDi>
    <basicUdiDi>081311002LIJ9</basicUdiDi>
    <tradeName>00813110023940</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-101-022</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T10:19:03.454Z</lastUpdated>
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    <udiDi>00813110024138</udiDi>
    <basicUdiDi>081311002LIJ9</basicUdiDi>
    <tradeName>00813110024138</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-101-120</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T10:19:03.086Z</lastUpdated>
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    <udiDi>00813110024145</udiDi>
    <basicUdiDi>081311002LIJ9</basicUdiDi>
    <tradeName>00813110024145</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-101-121</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T10:19:03.071Z</lastUpdated>
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    <udiDi>00813110024183</udiDi>
    <basicUdiDi>081311002LIJ9</basicUdiDi>
    <tradeName>00813110024183</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-101-125</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T10:19:02.978Z</lastUpdated>
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    <udiDi>00813110024206</udiDi>
    <basicUdiDi>081311002LIJ9</basicUdiDi>
    <tradeName>00813110024206</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-101-130</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T10:19:02.909Z</lastUpdated>
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    <udiDi>00813110024213</udiDi>
    <basicUdiDi>081311002LIJ9</basicUdiDi>
    <tradeName>00813110024213</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-101-135</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T10:19:02.864Z</lastUpdated>
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    <udiDi>00813110024220</udiDi>
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    <deviceName></deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-101-140</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T10:19:02.825Z</lastUpdated>
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    <udiDi>00813110024299</udiDi>
    <basicUdiDi>081311002LIJ9</basicUdiDi>
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    <deviceName></deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L159007</emdnCode>
    <emdnDescription>ODONTOSTOMATOLOGY BURS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-101-325</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-25T10:19:02.598Z</lastUpdated>
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