<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05056334601005</udiDi>
    <basicUdiDi>50563346DENTALCTABSUIGJ</basicUdiDi>
    <tradeName>Fresh &amp; Go Aligner &amp; Retainer Cleaning Tablets - 36 tablet carton</tradeName>
    <deviceName>Fresh &amp; Go Aligner &amp; Retainer Cleaning Tablets</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>9001-237</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:59:52.493Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334600374</udiDi>
    <basicUdiDi>50563346INSTRUMENTRUIXB</basicUdiDi>
    <tradeName>HOLLOW CHOP PLIERS FINE</tradeName>
    <deviceName>INSTRUMENTS</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>L150702</emdnCode>
    <emdnDescription>ORTHODONTIC PLIERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4150-906F</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:59:50.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334600343</udiDi>
    <basicUdiDi>50563346DURA-CHAINSUI2Z</basicUdiDi>
    <tradeName>Dura-Chain Narrow Link (Blue label)</tradeName>
    <deviceName>Orthodontic Dura-Chain</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>Q010404</emdnCode>
    <emdnDescription>ORTHODONTIC ELASTICS, CHAINS AND SPRINGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3002-849</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:59:49.297Z</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>2026-07-01T22:59:48.496Z</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>2026-07-01T22:59:47.689Z</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>2026-07-01T22:59:46.896Z</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>2026-07-01T22:59:46.082Z</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>2026-07-01T22:59:45.302Z</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>2026-07-01T22:59:43.682Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334600015</udiDi>
    <basicUdiDi>50563346VACUUMSUIPU</basicUdiDi>
    <tradeName>Excel Blanks .040 5x5" Square</tradeName>
    <deviceName>Vacuum Forming Sheets</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>9001-420</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:59:42.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334603801</udiDi>
    <basicUdiDi>50563346INSTRUMENTRUIXB</basicUdiDi>
    <tradeName>ORTHO-CARE MOSQUITO FORCEPS STRAIGHT</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>L03130499</emdnCode>
    <emdnDescription>GRASPING FORCEPS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>66-919</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-06-19T13:26:39.495Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334603788</udiDi>
    <basicUdiDi>50563346INSTRUMENTRUIXB</basicUdiDi>
    <tradeName>ORTHO-CARE MOSQUITO FORCEPS STRAIGHT</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>L03130499</emdnCode>
    <emdnDescription>GRASPING FORCEPS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>64-919</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-06-19T13:26:38.557Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334603771</udiDi>
    <basicUdiDi>50563346INSTRUMENTRUIXB</basicUdiDi>
    <tradeName>ORTHO-CARE BRACKET REMOVER ANGLED</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>L150702</emdnCode>
    <emdnDescription>ORTHODONTIC PLIERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63-221A</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-06-19T13:26:37.663Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334603764</udiDi>
    <basicUdiDi>50563346INSTRUMENTRUIXB</basicUdiDi>
    <tradeName>ORTHO-CARE POSTERIOR BAND REMOVERS LONG TIP</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>L150702</emdnCode>
    <emdnDescription>ORTHODONTIC PLIERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63-207</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-06-19T13:26:36.753Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334603757</udiDi>
    <basicUdiDi>50563346INSTRUMENTRUIXB</basicUdiDi>
    <tradeName>ORTHO-CARE POSTERIOR BAND REMOVERS SHORT TIP</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>L150702</emdnCode>
    <emdnDescription>ORTHODONTIC PLIERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63-208</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-06-19T13:26:35.853Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334603740</udiDi>
    <basicUdiDi>50563346INSTRUMENTRUIXB</basicUdiDi>
    <tradeName>ORTHO-CARE NITI CINCH BACK PLIERS DUAL DIRECTION LONG HANDLE MINI HEAD</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>L150702</emdnCode>
    <emdnDescription>ORTHODONTIC PLIERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63-100MH</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-06-19T13:26:34.949Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334603733</udiDi>
    <basicUdiDi>50563346INSTRUMENTRUIXB</basicUdiDi>
    <tradeName>ORTHO-CARE NITI CINCH BACK PLIERS DUAL DIRECTION LONG HANDLE, LONG HEAD</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>L150702</emdnCode>
    <emdnDescription>ORTHODONTIC PLIERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63-100LH</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-06-19T13:26:34.056Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334603726</udiDi>
    <basicUdiDi>50563346INSTRUMENTRUIXB</basicUdiDi>
    <tradeName>ORTHO-CARE MOLAR BOND TWEEZERS</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>L031308</emdnCode>
    <emdnDescription>SURGICAL AND ANATOMICAL TWEEZERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63-930</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-06-19T13:26:33.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334603719</udiDi>
    <basicUdiDi>50563346INSTRUMENTRUIXB</basicUdiDi>
    <tradeName>ORTHO-CARE BRACKET TWEEZERS WITH POSITIONER TIP</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>L031308</emdnCode>
    <emdnDescription>SURGICAL AND ANATOMICAL TWEEZERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63-928</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-06-19T13:26:32.259Z</lastUpdated>
  </row>
  <row>
    <udiDi>05056334603702</udiDi>
    <basicUdiDi>50563346INSTRUMENTRUIXB</basicUdiDi>
    <tradeName>ORTHO-CARE LINGUAL BRACKET TWEEZERS</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>L031308</emdnCode>
    <emdnDescription>SURGICAL AND ANATOMICAL TWEEZERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>63-925</reference>
    <placedOnMarketCountry>Malta</placedOnMarketCountry>
    <lastUpdated>2026-06-19T13:26:31.349Z</lastUpdated>
  </row>
</eudamedExport>