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    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:49:09.210Z</lastUpdated>
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    <manufacturerName>Ortho-Care (UK) Limited</manufacturerName>
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    <tradeName>EUROTHERM</tradeName>
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    <manufacturerName>Ortho-Care (UK) Limited</manufacturerName>
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    <tradeName>EUROTHERM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortho-Care (UK) Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000010884</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-09-21T22:48:52.761Z</lastUpdated>
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    <deviceName></deviceName>
    <manufacturerName>Ortho-Care (UK) Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000010884</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5929-013</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:48:52.069Z</lastUpdated>
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    <basicUdiDi>50563346ORTHOWIREMSUIIAWW</basicUdiDi>
    <tradeName>UNITHERM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortho-Care (UK) Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000010884</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5929-145</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:48:51.718Z</lastUpdated>
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    <udiDi>05056334603696</udiDi>
    <basicUdiDi>50563346ORTHOWIREMSUIIAWW</basicUdiDi>
    <tradeName>UNITHERM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortho-Care (UK) Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000010884</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010405</emdnCode>
    <emdnDescription>ORTHODONTIC WIRES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5929-285</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-09-21T22:48:51.498Z</lastUpdated>
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    <udiDi>00810000522880</udiDi>
    <basicUdiDi>B-00810000522880</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName>Universal 25k Internal Water Scaler Insert</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DUI25</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-04T22:08:46.534Z</lastUpdated>
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    <udiDi>00810000522873</udiDi>
    <basicUdiDi>B-00810000522873</basicUdiDi>
    <tradeName>Burnett Power-Tip™</tradeName>
    <deviceName>30k Burnett Power-Tip™ Internal Water</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>DTI30</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-04T22:08:42.569Z</lastUpdated>
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    <udiDi>00810000525737</udiDi>
    <basicUdiDi>B-00810000525737</basicUdiDi>
    <tradeName>Hyperfil®</tradeName>
    <deviceName>Hyperfil® 3ml Enamel Shade</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S235</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:16:25.941Z</lastUpdated>
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    <udiDi>00810000525720</udiDi>
    <basicUdiDi>B-00810000525720</basicUdiDi>
    <tradeName>Hyperfil®</tradeName>
    <deviceName>Hyperfil® 3ml Universal Shade</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S234</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:16:25.149Z</lastUpdated>
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    <udiDi>00810000525652</udiDi>
    <basicUdiDi>B-00810000525652</basicUdiDi>
    <tradeName>Predicta®</tradeName>
    <deviceName>Predicta® Bioactive Cement - White Opaque Shade</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0101010299</emdnCode>
    <emdnDescription>TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S632</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:16:24.333Z</lastUpdated>
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    <udiDi>00810000525645</udiDi>
    <basicUdiDi>B-00810000525645</basicUdiDi>
    <tradeName>Predicta™</tradeName>
    <deviceName>Predicta Cement</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0101010299</emdnCode>
    <emdnDescription>TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S631</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:16:23.534Z</lastUpdated>
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    <basicUdiDi>B-00810000525638</basicUdiDi>
    <tradeName>Predicta™</tradeName>
    <deviceName>Predicta Cement</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0101010299</emdnCode>
    <emdnDescription>TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S630</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:16:19.525Z</lastUpdated>
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    <udiDi>00810000525539</udiDi>
    <basicUdiDi>B-00810000525539</basicUdiDi>
    <tradeName>Predicta™</tradeName>
    <deviceName>Predicta Desensitizer</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q019008</emdnCode>
    <emdnDescription>DENTINAL DESENSITISERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S626</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:16:18.836Z</lastUpdated>
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    <basicUdiDi>B-00810000525461</basicUdiDi>
    <tradeName>Predicta™</tradeName>
    <deviceName>Predicta Bulk Fill</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S616</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:16:17.128Z</lastUpdated>
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    <basicUdiDi>B-00810000525454</basicUdiDi>
    <tradeName>Predicta™</tradeName>
    <deviceName>Predicta Bulk Fill</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S615</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:16:16.327Z</lastUpdated>
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    <udiDi>00810000525447</udiDi>
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    <tradeName>Predicta™</tradeName>
    <deviceName>Predicta Bulk Fill</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S611</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:16:12.331Z</lastUpdated>
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    <tradeName>Predicta™</tradeName>
    <deviceName>Predicta Bulk Fill</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S610</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:16:11.528Z</lastUpdated>
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    <basicUdiDi>B-00810000525423</basicUdiDi>
    <tradeName>Predicta™</tradeName>
    <deviceName>Predicta Core</deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>S606</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:16:10.745Z</lastUpdated>
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