<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
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    <basicUdiDi>01907460000124DM</basicUdiDi>
    <tradeName>Empower Bracket</tradeName>
    <deviceName></deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>485-73517</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:46:03.795Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746010897</udiDi>
    <basicUdiDi>01907460000124DM</basicUdiDi>
    <tradeName>Empower Bracket</tradeName>
    <deviceName></deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>485-73517B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:46:03.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746010903</udiDi>
    <basicUdiDi>01907460000124DM</basicUdiDi>
    <tradeName>Empower Bracket</tradeName>
    <deviceName></deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>485-73522</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:46:03.611Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746010910</udiDi>
    <basicUdiDi>01907460000124DM</basicUdiDi>
    <tradeName>Empower Bracket</tradeName>
    <deviceName></deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>485-73522B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:46:03.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746010958</udiDi>
    <basicUdiDi>01907460000124DM</basicUdiDi>
    <tradeName>Empower Bracket</tradeName>
    <deviceName></deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>485-74412B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:46:03.537Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746010965</udiDi>
    <basicUdiDi>01907460000124DM</basicUdiDi>
    <tradeName>Empower Bracket</tradeName>
    <deviceName></deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>485-74417</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T19:46:03.357Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746010293</udiDi>
    <basicUdiDi>01907460000124DM</basicUdiDi>
    <tradeName>Empower Bracket</tradeName>
    <deviceName></deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>485-230B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:42.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746077500</udiDi>
    <basicUdiDi>01907460000124DM</basicUdiDi>
    <tradeName>Empower Bracket</tradeName>
    <deviceName></deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>485-237B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:41.999Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746010309</udiDi>
    <basicUdiDi>01907460000124DM</basicUdiDi>
    <tradeName>Empower Bracket</tradeName>
    <deviceName></deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>485-2407</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:41.970Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746010316</udiDi>
    <basicUdiDi>01907460000124DM</basicUdiDi>
    <tradeName>Empower Bracket</tradeName>
    <deviceName></deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>485-2407B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:41.703Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746159305</udiDi>
    <basicUdiDi>01907460000124DM</basicUdiDi>
    <tradeName>Empower Bracket</tradeName>
    <deviceName></deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>485-2407HM</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:41.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746010323</udiDi>
    <basicUdiDi>01907460000124DM</basicUdiDi>
    <tradeName>Empower Bracket</tradeName>
    <deviceName></deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>485-2412</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:40.534Z</lastUpdated>
  </row>
  <row>
    <udiDi>00190746010330</udiDi>
    <basicUdiDi>01907460000124DM</basicUdiDi>
    <tradeName>Empower Bracket</tradeName>
    <deviceName></deviceName>
    <manufacturerName>American Orthodontics</manufacturerName>
    <manufacturerSrn>US-MF-000007702</manufacturerSrn>
    <authorisedRepresentativeName>Medical Technology Promedt Consulting GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000085</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>485-2412B</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-22T03:36:40.412Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840273923077</udiDi>
    <basicUdiDi>B-00840273923077</basicUdiDi>
    <tradeName>H4™ PLUS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>World Class Technology Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000014389</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H4 PLUS 7X7 U/L HKS 345 KIT</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:35:03.730Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840273923060</udiDi>
    <basicUdiDi>B-00840273923060</basicUdiDi>
    <tradeName>H4™ PLUS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>World Class Technology Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000014389</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>966.2155</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:34:59.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840273923053</udiDi>
    <basicUdiDi>B-00840273923053</basicUdiDi>
    <tradeName>H4™ PLUS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>World Class Technology Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000014389</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>966.2032</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:34:58.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840273923046</udiDi>
    <basicUdiDi>B-00840273923046</basicUdiDi>
    <tradeName>H4™ PLUS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>World Class Technology Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000014389</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>966.2025-10</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:34:58.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840273923039</udiDi>
    <basicUdiDi>B-00840273923039</basicUdiDi>
    <tradeName>H4™ PLUS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>World Class Technology Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000014389</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>966.2024-10</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:34:57.325Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840273923008</udiDi>
    <basicUdiDi>B-00840273923008</basicUdiDi>
    <tradeName>H4™ PLUS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>World Class Technology Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000014389</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>966.2017-10</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:34:53.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840273922995</udiDi>
    <basicUdiDi>B-00840273922995</basicUdiDi>
    <tradeName>H4™ PLUS</tradeName>
    <deviceName></deviceName>
    <manufacturerName>World Class Technology Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000014389</manufacturerSrn>
    <authorisedRepresentativeName>mdi Europa GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006218</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010403</emdnCode>
    <emdnDescription>ORTHODONTIC BRACKETS AND BUTTONS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>966.2016-10</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-21T20:34:52.519Z</lastUpdated>
  </row>
</eudamedExport>