<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-5268-5001N4</udiDi>
    <basicUdiDi>B-5268-5001N4</basicUdiDi>
    <tradeName>D-5268-5001N4</tradeName>
    <deviceName>Reverse Pull Headgear(Face Mask)</deviceName>
    <manufacturerName>ASTAR ORTHODONTICS INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000028647</manufacturerSrn>
    <authorisedRepresentativeName>BIO CONCEPT, UNIPESSOAL, LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000021480</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5268-5001</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:37:28.775Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5268-4000MT</udiDi>
    <basicUdiDi>B-5268-4000MT</basicUdiDi>
    <tradeName>ASTAR</tradeName>
    <deviceName>Reverse Pull Headgear(Face Mask)</deviceName>
    <manufacturerName>ASTAR ORTHODONTICS INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000028647</manufacturerSrn>
    <authorisedRepresentativeName>BIO CONCEPT, UNIPESSOAL, LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000021480</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5268-4000</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:37:27.628Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5240-0000GM</udiDi>
    <basicUdiDi>B-5240-0000GM</basicUdiDi>
    <tradeName>D-5240-0000GM</tradeName>
    <deviceName>Chin Cup</deviceName>
    <manufacturerName>ASTAR ORTHODONTICS INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000028647</manufacturerSrn>
    <authorisedRepresentativeName>BIO CONCEPT, UNIPESSOAL, LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000021480</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5240-0000</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:37:26.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5232-0000GW</udiDi>
    <basicUdiDi>B-5232-0000GW</basicUdiDi>
    <tradeName>D-5232-0000GW</tradeName>
    <deviceName>Head Cap</deviceName>
    <manufacturerName>ASTAR ORTHODONTICS INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000028647</manufacturerSrn>
    <authorisedRepresentativeName>BIO CONCEPT, UNIPESSOAL, LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000021480</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5232-0000</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:37:23.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5231-0000GH</udiDi>
    <basicUdiDi>B-5231-0000GH</basicUdiDi>
    <tradeName>D-5231-0000GH</tradeName>
    <deviceName>Extraoral Headgears</deviceName>
    <manufacturerName>ASTAR ORTHODONTICS INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000028647</manufacturerSrn>
    <authorisedRepresentativeName>BIO CONCEPT, UNIPESSOAL, LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000021480</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5231-0000</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:37:22.559Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5223-0000GS</udiDi>
    <basicUdiDi>B-5223-0000GS</basicUdiDi>
    <tradeName>D-5223-0000GS</tradeName>
    <deviceName>Safety-release module</deviceName>
    <manufacturerName>ASTAR ORTHODONTICS INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000028647</manufacturerSrn>
    <authorisedRepresentativeName>BIO CONCEPT, UNIPESSOAL, LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000021480</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5223-0000</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:37:21.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5222-0000GD</udiDi>
    <basicUdiDi>B-5222-0000GD</basicUdiDi>
    <tradeName>D-5222-0000GD</tradeName>
    <deviceName>Neck Pad</deviceName>
    <manufacturerName>ASTAR ORTHODONTICS INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000028647</manufacturerSrn>
    <authorisedRepresentativeName>BIO CONCEPT, UNIPESSOAL, LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000021480</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5222-0000</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:37:19.938Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5221-0000FY</udiDi>
    <basicUdiDi>B-5221-0000FY</basicUdiDi>
    <tradeName>D-5221-0000FY</tradeName>
    <deviceName>Extraoral Headgears</deviceName>
    <manufacturerName>ASTAR ORTHODONTICS INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000028647</manufacturerSrn>
    <authorisedRepresentativeName>BIO CONCEPT, UNIPESSOAL, LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000021480</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5221-0000</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:37:17.539Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5210-0111FC</udiDi>
    <basicUdiDi>B-5210-0111FC</basicUdiDi>
    <tradeName>D-5210-0111FC</tradeName>
    <deviceName>Face Bow</deviceName>
    <manufacturerName>ASTAR ORTHODONTICS INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000028647</manufacturerSrn>
    <authorisedRepresentativeName>BIO CONCEPT, UNIPESSOAL, LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000021480</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5210-0111</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:37:17.367Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5210-0104FF</udiDi>
    <basicUdiDi>B-5210-0104FF</basicUdiDi>
    <tradeName>D-5210-0104FF</tradeName>
    <deviceName>Face Bow</deviceName>
    <manufacturerName>ASTAR ORTHODONTICS INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000028647</manufacturerSrn>
    <authorisedRepresentativeName>BIO CONCEPT, UNIPESSOAL, LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000021480</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5210-0104</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:37:16.472Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5210-0097GB</udiDi>
    <basicUdiDi>B-5210-0097GB</basicUdiDi>
    <tradeName>D-5210-0097GB</tradeName>
    <deviceName>Face Bow</deviceName>
    <manufacturerName>ASTAR ORTHODONTICS INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000028647</manufacturerSrn>
    <authorisedRepresentativeName>BIO CONCEPT, UNIPESSOAL, LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000021480</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5210-0097</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:37:13.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5210-0090FV</udiDi>
    <basicUdiDi>B-5210-0090FV</basicUdiDi>
    <tradeName>D-5210-0090FV</tradeName>
    <deviceName>Face Bow</deviceName>
    <manufacturerName>ASTAR ORTHODONTICS INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000028647</manufacturerSrn>
    <authorisedRepresentativeName>BIO CONCEPT, UNIPESSOAL, LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000021480</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5210-0090</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:37:11.669Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5210-0083FY</udiDi>
    <basicUdiDi>B-5210-0083FY</basicUdiDi>
    <tradeName>D-5210-0083FY</tradeName>
    <deviceName>Face Bow</deviceName>
    <manufacturerName>ASTAR ORTHODONTICS INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000028647</manufacturerSrn>
    <authorisedRepresentativeName>BIO CONCEPT, UNIPESSOAL, LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000021480</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5210-0083</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:37:09.978Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-5210-0000F2</udiDi>
    <basicUdiDi>B-5210-0000F2</basicUdiDi>
    <tradeName>ASTAR</tradeName>
    <deviceName>Face Bow</deviceName>
    <manufacturerName>ASTAR ORTHODONTICS INC.</manufacturerName>
    <manufacturerSrn>CN-MF-000028647</manufacturerSrn>
    <authorisedRepresentativeName>BIO CONCEPT, UNIPESSOAL, LDA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000021480</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5210-0000</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-16T23:37:08.997Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989059922</udiDi>
    <basicUdiDi>0889989-ExOrl_FM_Accs-AK</basicUdiDi>
    <tradeName>CHIN/HEAD PAD SET AD PROT.F-MASK PK/3</tradeName>
    <deviceName>CHIN/HEAD PAD SET</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>716-0003</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:49:34.397Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989059908</udiDi>
    <basicUdiDi>0889989-ExOrl_Facemask-9W</basicUdiDi>
    <tradeName>A.D. PROTRACTION FACEMASK BLUE</tradeName>
    <deviceName>FACEMASK</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>716-0001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:49:33.578Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989059861</udiDi>
    <basicUdiDi>0889989-ExOrl_HG_Strap-TP</basicUdiDi>
    <tradeName>RELEASE MODULE/10 PK MED FORCE</tradeName>
    <deviceName>RELEASE MODULE</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>715-1020</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:49:31.979Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989059854</udiDi>
    <basicUdiDi>0889989-ExOrl_HG_Kit-FX</basicUdiDi>
    <tradeName>HI-PULL UNIT  BRITEGEAR     MED/BLACK</tradeName>
    <deviceName>BRITEGEAR</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>715-1010</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:49:29.574Z</lastUpdated>
  </row>
  <row>
    <udiDi>00889989059830</udiDi>
    <basicUdiDi>0889989-ExOrl_HG_N_Pad-BB</basicUdiDi>
    <tradeName>CERVICAL UNIT BRITEGEAR     MED/DENIM</tradeName>
    <deviceName>PAD</deviceName>
    <manufacturerName>Ormco Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000038085</manufacturerSrn>
    <authorisedRepresentativeName>KERR ITALIA SRL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IT-AR-000007600</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>715-1000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-16T04:49:27.174Z</lastUpdated>
  </row>
  <row>
    <udiDi>EMICMTB11</udiDi>
    <basicUdiDi>++EMICFAM3E7AYE</basicUdiDi>
    <tradeName>EMICMTB11</tradeName>
    <deviceName>Name: Barre Palatali
Model: Stainlees Steel palatal bars</deviceName>
    <manufacturerName>Micerium S.p.A.</manufacturerName>
    <manufacturerSrn>IT-MF-000010187</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010401</emdnCode>
    <emdnDescription>ORTHODONTIC FACE BOWS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MTB1</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-15T16:13:33.167Z</lastUpdated>
  </row>
</eudamedExport>