<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>06430035420889</udiDi>
    <basicUdiDi>6430035420205H</basicUdiDi>
    <tradeName>06430035420889</tradeName>
    <deviceName>Planmeca Emerald S</deviceName>
    <manufacturerName>Planmeca Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000006499</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30018474</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:52:19.251Z</lastUpdated>
  </row>
  <row>
    <udiDi>06430035420568</udiDi>
    <basicUdiDi>6430035420035H</basicUdiDi>
    <tradeName>06430035420568</tradeName>
    <deviceName>Planmeca Emerald</deviceName>
    <manufacturerName>Planmeca Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000006499</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30006359</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:52:17.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>04719883022011</udiDi>
    <basicUdiDi>471988302SCANNERVU</basicUdiDi>
    <tradeName>Phosphor Plate Scanner</tradeName>
    <deviceName>Phosphor Plate Scanner</deviceName>
    <manufacturerName>DHEF INC.</manufacturerName>
    <manufacturerSrn>TW-MF-000008480</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DIGIREX PSP</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T03:47:20.177Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437027816017</udiDi>
    <basicUdiDi>84370278163DLFSMaxVX</basicUdiDi>
    <tradeName>08437027816017</tradeName>
    <deviceName>3DLF Scanner Max – V2</deviceName>
    <manufacturerName>Voxelcare S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000048501</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3D Laser Plantar Foot Scanner Max</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-24T20:11:40.846Z</lastUpdated>
  </row>
  <row>
    <udiDi>08437027816000</udiDi>
    <basicUdiDi>84370278163DLFSCompactTY</basicUdiDi>
    <tradeName>08437027816000</tradeName>
    <deviceName>3DLF Scanner Compact</deviceName>
    <manufacturerName>Voxelcare S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000048501</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3D Laser Plantar Foot Scanner Compact</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-24T20:11:40.025Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063023203</udiDi>
    <basicUdiDi>081606302LMN22SYSEL</basicUdiDi>
    <tradeName>iTero Lumina PC cfg</tradeName>
    <deviceName>iTero Lumina – PC cfg</deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-PR-000047276</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>223100</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:20:35.798Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063023050</udiDi>
    <basicUdiDi>081606302LMNSCNUEV</basicUdiDi>
    <tradeName>iTero Lumina - PC cfg  intraoral scanning unit</tradeName>
    <deviceName>iTero Lumina PC cfg Intraoral Scanning Unit</deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>223102</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:20:28.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063021414</udiDi>
    <basicUdiDi>081606302LMNSYS9L</basicUdiDi>
    <tradeName>iTero Lumina Cart Configuration</tradeName>
    <deviceName>iTero Lumina System</deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>213782</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:20:08.427Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020493</udiDi>
    <basicUdiDi>081606302DISBH</basicUdiDi>
    <tradeName>iTero Element 5D</tradeName>
    <deviceName>iTero Element 5D Family</deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>205929</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:19:59.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020288</udiDi>
    <basicUdiDi>081606302ELEMENT6L</basicUdiDi>
    <tradeName>iTero Element 2</tradeName>
    <deviceName>iTero Element 2 family</deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>202965</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-16T01:19:54.406Z</lastUpdated>
  </row>
  <row>
    <udiDi>15060484490089</udiDi>
    <basicUdiDi>B-15060484490089</basicUdiDi>
    <tradeName>moorLDLS-BI</tradeName>
    <deviceName>moorLDLS-BI Laser Doppler Burns Imager and PC Software</deviceName>
    <manufacturerName>Moor Instruments Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000042552</manufacturerSrn>
    <authorisedRepresentativeName>Moor Instruments GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000041822</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>moorLDLS-BI</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:32:06.364Z</lastUpdated>
  </row>
  <row>
    <udiDi>15060484490072</udiDi>
    <basicUdiDi>B-15060484490072</basicUdiDi>
    <tradeName>moorLDI2-BI</tradeName>
    <deviceName>moorLDI2-BI Laser Doppler Burns Imager and PC Software</deviceName>
    <manufacturerName>Moor Instruments Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000042552</manufacturerSrn>
    <authorisedRepresentativeName>Moor Instruments GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000041822</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>moorLDI2-BI</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:32:05.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>15060484490041</udiDi>
    <basicUdiDi>B-15060484490041</basicUdiDi>
    <tradeName>moorFLPI-2</tradeName>
    <deviceName>moorFLPI-2 and PC Software</deviceName>
    <manufacturerName>Moor Instruments Ltd</manufacturerName>
    <manufacturerSrn>UK-MF-000042552</manufacturerSrn>
    <authorisedRepresentativeName>Moor Instruments GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000041822</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>moorFLPI-2</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T05:32:01.567Z</lastUpdated>
  </row>
  <row>
    <udiDi>00816063020295</udiDi>
    <basicUdiDi>081606302ELEMENT6L</basicUdiDi>
    <tradeName>iTero Element Flex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Align Technology Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000000745</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>202964</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-09T02:28:30.293Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033837937289</udiDi>
    <basicUdiDi>B-08033837937289</basicUdiDi>
    <tradeName>DXPS</tradeName>
    <deviceName>DXPS</deviceName>
    <manufacturerName>CEFLA s.c.</manufacturerName>
    <manufacturerSrn>IT-MF-000009228</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>95510218; 703J0000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:29:31.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033837937272</udiDi>
    <basicUdiDi>B-08033837937272</basicUdiDi>
    <tradeName>hy-scan</tradeName>
    <deviceName>hy-scan</deviceName>
    <manufacturerName>CEFLA s.c.</manufacturerName>
    <manufacturerSrn>IT-MF-000009228</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>95510216; 703I0000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:29:30.363Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033837937265</udiDi>
    <basicUdiDi>B-08033837937265</basicUdiDi>
    <tradeName>X-PSP</tradeName>
    <deviceName>X-PSP</deviceName>
    <manufacturerName>CEFLA s.c.</manufacturerName>
    <manufacturerSrn>IT-MF-000009228</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>95510209; 703E0000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:29:26.746Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033837937258</udiDi>
    <basicUdiDi>B-08033837937258</basicUdiDi>
    <tradeName>X-PSP</tradeName>
    <deviceName>X-PSP</deviceName>
    <manufacturerName>CEFLA s.c.</manufacturerName>
    <manufacturerSrn>IT-MF-000009228</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>95510206; 703G0000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:29:25.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033837937241</udiDi>
    <basicUdiDi>B-08033837937241</basicUdiDi>
    <tradeName>X-PSP</tradeName>
    <deviceName>X-PSP</deviceName>
    <manufacturerName>CEFLA s.c.</manufacturerName>
    <manufacturerSrn>IT-MF-000009228</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>95510205; 703F0000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:29:24.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>08033837937234</udiDi>
    <basicUdiDi>B-08033837937234</basicUdiDi>
    <tradeName>X-PSP</tradeName>
    <deviceName>X-PSP</deviceName>
    <manufacturerName>CEFLA s.c.</manufacturerName>
    <manufacturerSrn>IT-MF-000009228</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z110601</emdnCode>
    <emdnDescription>LASER IMAGING SCANNER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>95510204; 703H0000</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-07T14:29:23.964Z</lastUpdated>
  </row>
</eudamedExport>