<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05056334600091</udiDi>
    <basicUdiDi>50563346VACUUMSUIPU</basicUdiDi>
    <tradeName>Excel Retainer .030 120mm Round</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortho-Care (UK) Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000010884</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9001-424</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:35:27.166Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334600114</udiDi>
    <basicUdiDi>50563346VACUUMSUIPU</basicUdiDi>
    <tradeName>Excel Retainer .030 125mm Round</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortho-Care (UK) Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000010884</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9001-425</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:35:27.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334600138</udiDi>
    <basicUdiDi>50563346MP2SUIJ3</basicUdiDi>
    <tradeName>MP2 10kg Acrylic polymer powder</tradeName>
    <deviceName>Orthodontic MP2 Acrylic - no longer sold on EU Market</deviceName>
    <manufacturerName>Ortho-Care (UK) Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000010884</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01010105</emdnCode>
    <emdnDescription>DENTAL RESTORATION COMPOMERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>2131-004</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:35:27.100Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334600145</udiDi>
    <basicUdiDi>50563346MP2SUIJ3</basicUdiDi>
    <tradeName>MP2 5L Clear Acrylic monomer liquid</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortho-Care (UK) Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000010884</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010105</emdnCode>
    <emdnDescription>DENTAL RESTORATION COMPOMERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>2131-005</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:35:27.078Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334600152</udiDi>
    <basicUdiDi>50563346MP2SUIJ3</basicUdiDi>
    <tradeName>MP2 5L Pink Acrylic Monomer liquid</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortho-Care (UK) Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000010884</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010105</emdnCode>
    <emdnDescription>DENTAL RESTORATION COMPOMERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>2131-006</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:35:27.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334600169</udiDi>
    <basicUdiDi>50563346MP2SUIJ3</basicUdiDi>
    <tradeName>MP2 50kg Acrylic polymer powder</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortho-Care (UK) Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000010884</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010105</emdnCode>
    <emdnDescription>DENTAL RESTORATION COMPOMERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>2131-007</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:35:27.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334600176</udiDi>
    <basicUdiDi>50563346MP2SUIJ3</basicUdiDi>
    <tradeName>MP2 1Kg Acrylic Polymer Powder</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortho-Care (UK) Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000010884</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010105</emdnCode>
    <emdnDescription>DENTAL RESTORATION COMPOMERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>2131-011</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:35:27.015Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334600183</udiDi>
    <basicUdiDi>50563346MP2SUIJ3</basicUdiDi>
    <tradeName>MP2 500ml Clear Acrylic Monomer liquid</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortho-Care (UK) Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000010884</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010105</emdnCode>
    <emdnDescription>DENTAL RESTORATION COMPOMERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>2131-012</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:35:26.993Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334600190</udiDi>
    <basicUdiDi>50563346MP2SUIJ3</basicUdiDi>
    <tradeName>MP2 500ml Pink acrylic monomer liquid</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortho-Care (UK) Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000010884</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010105</emdnCode>
    <emdnDescription>DENTAL RESTORATION COMPOMERS</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>2131-013</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:35:26.965Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334600213</udiDi>
    <basicUdiDi>50563346RELIEFWAXSUIWZ</basicUdiDi>
    <tradeName>Ortho-Care Relief Wax</tradeName>
    <deviceName>Orthodontic Relief Wax</deviceName>
    <manufacturerName>Ortho-Care (UK) Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000010884</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>860-110OC</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:35:26.950Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334600220</udiDi>
    <basicUdiDi>50563346ALGINATESUIJK</basicUdiDi>
    <tradeName>Ortho-Care Alginate</tradeName>
    <deviceName>Orthodontic Alginate</deviceName>
    <manufacturerName>Ortho-Care (UK) Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000010884</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q01020101</emdnCode>
    <emdnDescription>DENTAL IMPRESSION ALGINATES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9001-IE002</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:35:26.912Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334600244</udiDi>
    <basicUdiDi>50563346ALIGNERCHEWRUIMA</basicUdiDi>
    <tradeName>Aligner Chews</tradeName>
    <deviceName>Aligner Chews</deviceName>
    <manufacturerName>Ortho-Care (UK) Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000010884</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9001-AC-01</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:35:26.893Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334600251</udiDi>
    <basicUdiDi>50563346ALIGNERREMRUIL5</basicUdiDi>
    <tradeName>OrthoCare Aligner Remover tool</tradeName>
    <deviceName>OrthoCare Aligner Remover tool</deviceName>
    <manufacturerName>Ortho-Care (UK) Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000010884</manufacturerSrn>
    <authorisedRepresentativeName>Directa AB</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>SE-AR-000002492</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010499</emdnCode>
    <emdnDescription>ORTHODONTIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9001-ART02</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:35:26.869Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334600268</udiDi>
    <basicUdiDi>50563346IMPRESSIONSUIJW</basicUdiDi>
    <tradeName>Impression tray, small upper yellow</tradeName>
    <deviceName>Orthodontic Impression Trays</deviceName>
    <manufacturerName>Ortho-Care (UK) Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000010884</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q010503</emdnCode>
    <emdnDescription>IMPRESSION MATERIAL TRAYS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>150-301</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:35:26.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334600275</udiDi>
    <basicUdiDi>50563346IMPRESSIONSUIJW</basicUdiDi>
    <tradeName>05056334600275</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortho-Care (UK) Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000010884</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010503</emdnCode>
    <emdnDescription>IMPRESSION MATERIAL TRAYS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>150-302</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:35:26.801Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334600282</udiDi>
    <basicUdiDi>50563346IMPRESSIONSUIJW</basicUdiDi>
    <tradeName>05056334600282</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortho-Care (UK) Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000010884</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010503</emdnCode>
    <emdnDescription>IMPRESSION MATERIAL TRAYS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>150-303</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:35:26.778Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334600299</udiDi>
    <basicUdiDi>50563346IMPRESSIONSUIJW</basicUdiDi>
    <tradeName>05056334600299</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortho-Care (UK) Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000010884</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010503</emdnCode>
    <emdnDescription>IMPRESSION MATERIAL TRAYS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>150-304</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:35:26.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334600305</udiDi>
    <basicUdiDi>50563346IMPRESSIONSUIJW</basicUdiDi>
    <tradeName>05056334600305</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortho-Care (UK) Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000010884</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010503</emdnCode>
    <emdnDescription>IMPRESSION MATERIAL TRAYS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>150-305</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:35:26.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334600312</udiDi>
    <basicUdiDi>50563346IMPRESSIONSUIJW</basicUdiDi>
    <tradeName>05056334600312</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortho-Care (UK) Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000010884</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010503</emdnCode>
    <emdnDescription>IMPRESSION MATERIAL TRAYS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>150-306</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:35:26.714Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334600329</udiDi>
    <basicUdiDi>50563346IMPRESSIONSUIJW</basicUdiDi>
    <tradeName>05056334600329</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Ortho-Care (UK) Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000010884</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q010503</emdnCode>
    <emdnDescription>IMPRESSION MATERIAL TRAYS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>150-001</reference>
    <placedOnMarketCountry>Northern Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T16:35:26.671Z</lastUpdated>
  </row>
</eudamedExport>