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    <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>MDR 2017/745</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>S622</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:31.421Z</lastUpdated>
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    <basicUdiDi>081000052APPBRUSH84</basicUdiDi>
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    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
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    <reference>S391</reference>
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    <udiDi>10810000528261</udiDi>
    <basicUdiDi>081000052MIXINGTIPWR</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
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    <basicUdiDi>081000052MIXINGTIP5K5</basicUdiDi>
    <tradeName>Parkell®</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Parkell Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000003761</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
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    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S540</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:31.312Z</lastUpdated>
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    <udiDi>10810000528308</udiDi>
    <basicUdiDi>081000052MIXINGTIP5K5</basicUdiDi>
    <tradeName>Parkell®</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>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S545</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:38:31.292Z</lastUpdated>
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    <udiDi>05060493850105</udiDi>
    <basicUdiDi>1506049385Oil8N</basicUdiDi>
    <tradeName>polydent Universal Handpiece Oil Spray</tradeName>
    <deviceName>Universal Handpiece Oil</deviceName>
    <manufacturerName>Topdental (Products) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000003937</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12110185</emdnCode>
    <emdnDescription>INSTRUMENTS FOR DENTAL TREATMENT UNITS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1899-001</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:23:54.419Z</lastUpdated>
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    <udiDi>+E165600210610</udiDi>
    <basicUdiDi>1506049385UltrasonicJ6</basicUdiDi>
    <tradeName>Coltene Bioscience UC40</tradeName>
    <deviceName>Ultrasonic Cleaner</deviceName>
    <manufacturerName>Topdental (Products) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000003937</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60021961</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:22:18.382Z</lastUpdated>
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    <tradeName>Coltene Biosonic UC40</tradeName>
    <deviceName>Ultrasonic Cleaner</deviceName>
    <manufacturerName>Topdental (Products) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000003937</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>60021960</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-01T07:56:33.541Z</lastUpdated>
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    <udiDi>10810000526984</udiDi>
    <basicUdiDi>081000052MIXINGTIP3JZ</basicUdiDi>
    <tradeName>Parkell®</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>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S439K</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:31:35.692Z</lastUpdated>
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    <udiDi>10810000526953</udiDi>
    <basicUdiDi>081000052MIXINGTIP2JX</basicUdiDi>
    <tradeName>Parkell®</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>MDR 2017/745</legislation>
    <emdnCode>Q019006</emdnCode>
    <emdnDescription>DENTAL MATERIAL APPLICATION TIPS AND BRUSHES, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S344</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:31:35.482Z</lastUpdated>
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    <udiDi>10810000522641</udiDi>
    <basicUdiDi>081000052ORINGUT</basicUdiDi>
    <tradeName>Parkell®</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>MDR 2017/745</legislation>
    <emdnCode>Z12119001</emdnCode>
    <emdnDescription>TARTAR ABLATORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DORING-GR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T19:31:35.026Z</lastUpdated>
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    <udiDi>20810000525083</udiDi>
    <basicUdiDi>081000052DRYZXK</basicUdiDi>
    <tradeName>DryZ®</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>MDR 2017/745</legislation>
    <emdnCode>Q010204</emdnCode>
    <emdnDescription>RETRACTION WIRES AND GINGIVAL RETRACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S182</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T22:16:56.917Z</lastUpdated>
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    <udiDi>20810000525168</udiDi>
    <basicUdiDi>081000052DRYZXK</basicUdiDi>
    <tradeName>DryZ®</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>MDR 2017/745</legislation>
    <emdnCode>Q010204</emdnCode>
    <emdnDescription>RETRACTION WIRES AND GINGIVAL RETRACTORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S191</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-20T22:16:56.892Z</lastUpdated>
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    <udiDi>05060493855407</udiDi>
    <basicUdiDi>1506049385UltrasonicJ6</basicUdiDi>
    <tradeName>Crown Dental Supply Ultrasonic Cleaner</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Topdental (Products) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000003937</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>123-044</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:40:16.570Z</lastUpdated>
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    <udiDi>05060493855391</udiDi>
    <basicUdiDi>1506049385UltrasonicJ6</basicUdiDi>
    <tradeName>Crown Dental Supply Ultrasonic Cleaner</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Topdental (Products) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000003937</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>123-043</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:40:15.670Z</lastUpdated>
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    <udiDi>05060493855209</udiDi>
    <basicUdiDi>1506049385Oil8N</basicUdiDi>
    <tradeName>Crown Dental Supply Universal Handpiece Oil</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Topdental (Products) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000003937</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12110185</emdnCode>
    <emdnDescription>INSTRUMENTS FOR DENTAL TREATMENT UNITS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>107-001</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:40:14.763Z</lastUpdated>
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    <udiDi>05060493854516</udiDi>
    <basicUdiDi>1506049385UltrasonicJ6</basicUdiDi>
    <tradeName>Unodent Enzymatic Ultrasonic Cleaner</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Topdental (Products) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000003937</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GUC005</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:40:07.755Z</lastUpdated>
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    <basicUdiDi>1506049385UltrasonicJ6</basicUdiDi>
    <tradeName>Unodent Enzymatic Ultrasonic Cleaner</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Topdental (Products) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000003937</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
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    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GUC000</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:40:06.860Z</lastUpdated>
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    <udiDi>05060493853892</udiDi>
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    <tradeName>Wrights Apex Universal Handpiece Oil</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Topdental (Products) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000003937</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12110185</emdnCode>
    <emdnDescription>INSTRUMENTS FOR DENTAL TREATMENT UNITS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2S00519</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:40:05.952Z</lastUpdated>
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    <basicUdiDi>1506049385UltrasonicJ6</basicUdiDi>
    <tradeName>Wrights UltraClean</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Topdental (Products) Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000003937</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>D0801</emdnCode>
    <emdnDescription>ENZYMATIC DETERGENTS FOR MEDICAL DEVICES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2S03195</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-06-19T20:40:05.049Z</lastUpdated>
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