<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>04987669100455</udiDi>
    <basicUdiDi>4987669205GA</basicUdiDi>
    <tradeName>US-500 ECHOSCAN</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIDEK.CO.Ltd.,</manufacturerName>
    <manufacturerSrn>JP-MF-000040151</manufacturerSrn>
    <authorisedRepresentativeName>NIDEK SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000341</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120116</emdnCode>
    <emdnDescription>PACHYMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B01E012</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:42:31.745Z</lastUpdated>
  </row>
  <row>
    <udiDi>04987669100448</udiDi>
    <basicUdiDi>4987669206GC</basicUdiDi>
    <tradeName>ECHOSCAN US-4000</tradeName>
    <deviceName></deviceName>
    <manufacturerName>NIDEK.CO.Ltd.,</manufacturerName>
    <manufacturerSrn>JP-MF-000040151</manufacturerSrn>
    <authorisedRepresentativeName>NIDEK SA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000000341</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120116</emdnCode>
    <emdnDescription>PACHYMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B01E012</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:42:27.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857377006018</udiDi>
    <basicUdiDi>B-00857377006018</basicUdiDi>
    <tradeName>Pachette 4</tradeName>
    <deviceName>Pachette 4</deviceName>
    <manufacturerName>DGH Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008833</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120116</emdnCode>
    <emdnDescription>PACHYMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DGH 555B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:33:21.732Z</lastUpdated>
  </row>
  <row>
    <udiDi>00857377006001</udiDi>
    <basicUdiDi>B-00857377006001</basicUdiDi>
    <tradeName>Pachmate 2</tradeName>
    <deviceName>Pachmate 2</deviceName>
    <manufacturerName>DGH Technology, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000008833</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120116</emdnCode>
    <emdnDescription>PACHYMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>DGH 55B</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:33:20.127Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700542626009</udiDi>
    <basicUdiDi>37005426POCKETIIIBE</basicUdiDi>
    <tradeName>POCKET III</tradeName>
    <deviceName>POCKET III</deviceName>
    <manufacturerName>QUANTEL MEDICAL</manufacturerName>
    <manufacturerSrn>FR-MF-000009724</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120116</emdnCode>
    <emdnDescription>PACHYMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>POCKET III</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T11:27:32.701Z</lastUpdated>
  </row>
  <row>
    <udiDi>08904343700325</udiDi>
    <basicUdiDi>89043437APPASCANMAXZ3</basicUdiDi>
    <tradeName>Appasamy</tradeName>
    <deviceName>OPHTHALMIC ULTRASOUND SCANNER</deviceName>
    <manufacturerName>APPASAMY ASSOCIATES PRIVATE LIMITED</manufacturerName>
    <manufacturerSrn>IN-MF-000013149</manufacturerSrn>
    <authorisedRepresentativeName>Amstermed B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001971</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12120116</emdnCode>
    <emdnDescription>PACHYMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Appascan Max P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T07:49:35.225Z</lastUpdated>
  </row>
</eudamedExport>