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    <tradeName>SPEED Protector Coil</tradeName>
    <deviceName>SPEED System Orthodontic Appliance and Accessories</deviceName>
    <manufacturerName>Hespeler Orthodontics Limited</manufacturerName>
    <manufacturerSrn>CA-MF-000008642</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07540295000314</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-15T11:01:30.501Z</lastUpdated>
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    <basicUdiDi>75402950C6</basicUdiDi>
    <tradeName>Hills Dual-Geometry Wire</tradeName>
    <deviceName>SPEED System Orthodontic Appliance and Accessories</deviceName>
    <manufacturerName>Hespeler Orthodontics Limited</manufacturerName>
    <manufacturerSrn>CA-MF-000008642</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07540295000154</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-12T19:50:10.732Z</lastUpdated>
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    <udiDi>07540295000086</udiDi>
    <basicUdiDi>75402950C6</basicUdiDi>
    <tradeName>SPEED Convertible Buccal Tube</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hespeler Orthodontics Limited</manufacturerName>
    <manufacturerSrn>CA-MF-000008642</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <deviceStatus>Piyasada</deviceStatus>
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    <basicUdiDi>75402950C6</basicUdiDi>
    <tradeName>SPEED Convertible Buccal Tube</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hespeler Orthodontics Limited</manufacturerName>
    <manufacturerSrn>CA-MF-000008642</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
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    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07540295000093</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T19:48:21.845Z</lastUpdated>
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    <udiDi>07540295000109</udiDi>
    <basicUdiDi>75402950C6</basicUdiDi>
    <tradeName>SPEED Convertible Buccal Tube</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hespeler Orthodontics Limited</manufacturerName>
    <manufacturerSrn>CA-MF-000008642</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07540295000109</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T19:48:21.296Z</lastUpdated>
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    <udiDi>07540295000116</udiDi>
    <basicUdiDi>75402950C6</basicUdiDi>
    <tradeName>SPEED Beta Titanium Archwire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hespeler Orthodontics Limited</manufacturerName>
    <manufacturerSrn>CA-MF-000008642</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07540295000116</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T19:48:12.189Z</lastUpdated>
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    <udiDi>07540295000123</udiDi>
    <basicUdiDi>75402950C6</basicUdiDi>
    <tradeName>SPEED Coaxial Archwire</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hespeler Orthodontics Limited</manufacturerName>
    <manufacturerSrn>CA-MF-000008642</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07540295000123</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-12T19:47:09.753Z</lastUpdated>
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    <udiDi>07540295000031</udiDi>
    <basicUdiDi>75402950C6</basicUdiDi>
    <tradeName>SPEED Bracket</tradeName>
    <deviceName>SPEED System Orthodontic Appliance and Accessories</deviceName>
    <manufacturerName>Hespeler Orthodontics Limited</manufacturerName>
    <manufacturerSrn>CA-MF-000008642</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07540295000031</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-11T20:04:14.177Z</lastUpdated>
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    <udiDi>07540295000024</udiDi>
    <basicUdiDi>75402950C6</basicUdiDi>
    <tradeName>SPEED Bracket</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hespeler Orthodontics Limited</manufacturerName>
    <manufacturerSrn>CA-MF-000008642</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07540295000024</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-11T19:56:52.431Z</lastUpdated>
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    <udiDi>07540295000048</udiDi>
    <basicUdiDi>75402950C6</basicUdiDi>
    <tradeName>SPEED Buccal Tube</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hespeler Orthodontics Limited</manufacturerName>
    <manufacturerSrn>CA-MF-000008642</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07540295000048</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-11T19:56:24.798Z</lastUpdated>
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    <udiDi>07540295000055</udiDi>
    <basicUdiDi>75402950C6</basicUdiDi>
    <tradeName>SPEED Buccal Tube</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hespeler Orthodontics Limited</manufacturerName>
    <manufacturerSrn>CA-MF-000008642</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07540295000055</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-11T19:56:23.769Z</lastUpdated>
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    <udiDi>07540295000062</udiDi>
    <basicUdiDi>75402950C6</basicUdiDi>
    <tradeName>SPEED Buccal Tube</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hespeler Orthodontics Limited</manufacturerName>
    <manufacturerSrn>CA-MF-000008642</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07540295000062</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-11T19:56:23.329Z</lastUpdated>
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    <udiDi>07540295000079</udiDi>
    <basicUdiDi>75402950C6</basicUdiDi>
    <tradeName>SPEED Buccal Tube Samples</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Hespeler Orthodontics Limited</manufacturerName>
    <manufacturerSrn>CA-MF-000008642</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>07540295000079</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-08-11T19:56:00.053Z</lastUpdated>
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