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    <tradeName>HANEL Occlusion foil 12µ 80mm 2sided red</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:49:11.581Z</lastUpdated>
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    <udiDi>E1654800530</udiDi>
    <basicUdiDi>++E165TAU1OCFX0012C</basicUdiDi>
    <tradeName>HANEL Occlusion foil 12µ 80mm 2sided green</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>Q01020299</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>E1654801650</udiDi>
    <basicUdiDi>++E165TAU1OCFX0012C</basicUdiDi>
    <tradeName>HANEL Occlusion foil 12µ 22mm red-black</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>MDR 2017/745</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
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    <udiDi>E1655110010</udiDi>
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    <tradeName>roeko Retracto / braided / non-impregnated, fine (1), 225 cm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010204</emdnCode>
    <emdnDescription>RETRACTION WIRES AND GINGIVAL RETRACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>511001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:49:11.538Z</lastUpdated>
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    <udiDi>E1655110020</udiDi>
    <basicUdiDi>++E165PRO1RETO40014E</basicUdiDi>
    <tradeName>roeko Retracto / braided  / non-impregnated,  medium (2), 225 cm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010204</emdnCode>
    <emdnDescription>RETRACTION WIRES AND GINGIVAL RETRACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>511002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>E1655110030</udiDi>
    <basicUdiDi>++E165PRO1RETO40014E</basicUdiDi>
    <tradeName>roeko Retracto / braided / non-impregnated, thick (3), 225 cm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010204</emdnCode>
    <emdnDescription>RETRACTION WIRES AND GINGIVAL RETRACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>511003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:49:11.513Z</lastUpdated>
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    <udiDi>E1655210010</udiDi>
    <basicUdiDi>++E165PRO1STPU4001DE</basicUdiDi>
    <tradeName>roeko Stay-put / non-impregnated, fine (1), 183 cm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010204</emdnCode>
    <emdnDescription>RETRACTION WIRES AND GINGIVAL RETRACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>521001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:49:11.475Z</lastUpdated>
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    <udiDi>E1655210020</udiDi>
    <basicUdiDi>++E165PRO1STPU4001DE</basicUdiDi>
    <tradeName>roeko Stay-put / non-impregnated, medium (2), 183 cm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010204</emdnCode>
    <emdnDescription>RETRACTION WIRES AND GINGIVAL RETRACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>521002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:49:11.459Z</lastUpdated>
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    <udiDi>E1655210030</udiDi>
    <basicUdiDi>++E165PRO1STPU4001DE</basicUdiDi>
    <tradeName>roeko Stay-put / non-impregnated, thick (3), 183 cm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010204</emdnCode>
    <emdnDescription>RETRACTION WIRES AND GINGIVAL RETRACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>521003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:49:11.446Z</lastUpdated>
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    <udiDi>E1655230000</udiDi>
    <basicUdiDi>++E165PRO1RETO40014E</basicUdiDi>
    <tradeName>roeko Retracto / twisted / non-impregnated, x-fine (0),  225 cm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010204</emdnCode>
    <emdnDescription>RETRACTION WIRES AND GINGIVAL RETRACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>523000</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:49:11.422Z</lastUpdated>
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    <udiDi>E1655230010</udiDi>
    <basicUdiDi>++E165PRO1RETO40014E</basicUdiDi>
    <tradeName>roeko Retracto / twisted / non-impregnated, fine (1), 225 cm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010204</emdnCode>
    <emdnDescription>RETRACTION WIRES AND GINGIVAL RETRACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>523001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:49:11.407Z</lastUpdated>
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    <udiDi>E1655230020</udiDi>
    <basicUdiDi>++E165PRO1RETO40014E</basicUdiDi>
    <tradeName>roeko Retracto / twisted / non-impregnated, medium (2), 225 cm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010204</emdnCode>
    <emdnDescription>RETRACTION WIRES AND GINGIVAL RETRACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>523002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:49:11.392Z</lastUpdated>
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    <udiDi>E1655300101</udiDi>
    <basicUdiDi>++E165PRO1COCA4001LZ</basicUdiDi>
    <tradeName>roeko Comprecap #3, 120 pcs</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>530010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:49:11.353Z</lastUpdated>
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    <udiDi>E1655300141</udiDi>
    <basicUdiDi>++E165PRO1COCA4001LZ</basicUdiDi>
    <tradeName>roeko Comprecap #5, 60 pcs</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>530014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:49:11.337Z</lastUpdated>
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    <udiDi>E1655310081</udiDi>
    <basicUdiDi>++E165PRO1COCA4001LZ</basicUdiDi>
    <tradeName>roeko Comprecap #1, 600 pcs</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>531008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:49:11.322Z</lastUpdated>
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    <udiDi>E1655310101</udiDi>
    <basicUdiDi>++E165PRO1COCA4001LZ</basicUdiDi>
    <tradeName>roeko Comprecap #3, 600 pcs</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:49:11.308Z</lastUpdated>
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    <udiDi>E1655310141</udiDi>
    <basicUdiDi>++E165PRO1COCA4001LZ</basicUdiDi>
    <tradeName>roeko Comprecap #5, 400 pcs</tradeName>
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    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>531014</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:49:11.290Z</lastUpdated>
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    <udiDi>E1655312011</udiDi>
    <basicUdiDi>++E165PRO1COCA4001LZ</basicUdiDi>
    <tradeName>roeko Comprecap anatomic #1, 120 pcs</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>531201</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:49:11.274Z</lastUpdated>
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    <udiDi>E1655312031</udiDi>
    <basicUdiDi>++E165PRO1COCA4001LZ</basicUdiDi>
    <tradeName>roeko Comprecap anatomic #3, 120 pcs</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-15T22:49:11.256Z</lastUpdated>
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    <udiDi>E1655312051</udiDi>
    <basicUdiDi>++E165PRO1COCA4001LZ</basicUdiDi>
    <tradeName>roeko Comprecap anatomic #5, 60 pcs</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Coltène/Whaledent GmbH + Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000005717</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q0199</emdnCode>
    <emdnDescription>ODONTOLOGY DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
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