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<eudamedExport entity="devices">
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    <udiDi>00897826002352</udiDi>
    <basicUdiDi>B-00897826002352</basicUdiDi>
    <tradeName>UBM Plus Guarded</tradeName>
    <deviceName>UBM Plus Guarded</deviceName>
    <manufacturerName>Accutome Inc. DBA Keeler USA</manufacturerName>
    <manufacturerSrn>US-MF-000036181</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24-6300-G</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:51.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>00897826002345</udiDi>
    <basicUdiDi>B-00897826002345</basicUdiDi>
    <tradeName>Pachymeter Probe 4SIGHT</tradeName>
    <deviceName>Pachymeter Probe 4SIGHT</deviceName>
    <manufacturerName>Accutome Inc. DBA Keeler USA</manufacturerName>
    <manufacturerSrn>US-MF-000036181</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24-8000P</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:50.330Z</lastUpdated>
  </row>
  <row>
    <udiDi>00897826002321</udiDi>
    <basicUdiDi>B-00897826002321</basicUdiDi>
    <tradeName>A-Scan Probe</tradeName>
    <deviceName>A-Scan Probe</deviceName>
    <manufacturerName>Accutome Inc. DBA Keeler USA</manufacturerName>
    <manufacturerSrn>US-MF-000036181</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24-4001</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:47.931Z</lastUpdated>
  </row>
  <row>
    <udiDi>00897826002307</udiDi>
    <basicUdiDi>B-00897826002307</basicUdiDi>
    <tradeName>A-Scan Probe 4SIGHT</tradeName>
    <deviceName>A-Scan Probe 4Sight</deviceName>
    <manufacturerName>Accutome Inc. DBA Keeler USA</manufacturerName>
    <manufacturerSrn>US-MF-000036181</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24-8000A</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:46.329Z</lastUpdated>
  </row>
  <row>
    <udiDi>00897826002123</udiDi>
    <basicUdiDi>B-00897826002123</basicUdiDi>
    <tradeName>B-Scan Probe 4SIGHT</tradeName>
    <deviceName>B-Scan Probe 4SIGHT</deviceName>
    <manufacturerName>Accutome Inc. DBA Keeler USA</manufacturerName>
    <manufacturerSrn>US-MF-000036181</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24-8000B</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:45.530Z</lastUpdated>
  </row>
  <row>
    <udiDi>00897826002314</udiDi>
    <basicUdiDi>B-00897826002314</basicUdiDi>
    <tradeName>UBM Probe 4SIGHT</tradeName>
    <deviceName>UBM Probe 4SIGHT</deviceName>
    <manufacturerName>Accutome Inc. DBA Keeler USA</manufacturerName>
    <manufacturerSrn>US-MF-000036181</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24-8000U</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:44.031Z</lastUpdated>
  </row>
  <row>
    <udiDi>00897826002116</udiDi>
    <basicUdiDi>B-00897826002116</basicUdiDi>
    <tradeName>AccuTip Covers, 600/bx, bulk</tradeName>
    <deviceName>AccuTip Covers, 600/bx, bulk</deviceName>
    <manufacturerName>Accutome Inc. DBA Keeler USA</manufacturerName>
    <manufacturerSrn>US-MF-000036181</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120199</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AX11286</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:30.265Z</lastUpdated>
  </row>
  <row>
    <udiDi>00897826002109</udiDi>
    <basicUdiDi>B-00897826002109</basicUdiDi>
    <tradeName>AccuTip Covers, 100 sleeved bulk bag</tradeName>
    <deviceName>AccuTip Covers, 100 sleeved bulk bag</deviceName>
    <manufacturerName>Accutome Inc. DBA Keeler USA</manufacturerName>
    <manufacturerSrn>US-MF-000036181</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120199</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AX11526</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:26.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>00897826002093</udiDi>
    <basicUdiDi>B-00897826002093</basicUdiDi>
    <tradeName>AccuTip Covers, 300/bx, individually wrapped</tradeName>
    <deviceName>AccuTip Covers, 300/bx, individually wrapped</deviceName>
    <manufacturerName>Accutome Inc. DBA Keeler USA</manufacturerName>
    <manufacturerSrn>US-MF-000036181</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120199</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AX11932</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:25.464Z</lastUpdated>
  </row>
  <row>
    <udiDi>00897826002086</udiDi>
    <basicUdiDi>B-00897826002086</basicUdiDi>
    <tradeName>AccuTip Covers, 100/bx, individually wrapped</tradeName>
    <deviceName>AccuTip Covers, 100/bx, individually wrapped</deviceName>
    <manufacturerName>Accutome Inc. DBA Keeler USA</manufacturerName>
    <manufacturerSrn>US-MF-000036181</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120199</emdnCode>
    <emdnDescription>OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AX9950</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:24.665Z</lastUpdated>
  </row>
  <row>
    <udiDi>00897826002079</udiDi>
    <basicUdiDi>B-00897826002079</basicUdiDi>
    <tradeName>4Sight</tradeName>
    <deviceName>4Sight</deviceName>
    <manufacturerName>Accutome Inc. DBA Keeler USA</manufacturerName>
    <manufacturerSrn>US-MF-000036181</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24-8000</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:23.867Z</lastUpdated>
  </row>
  <row>
    <udiDi>00897826002031</udiDi>
    <basicUdiDi>B-00897826002031</basicUdiDi>
    <tradeName>B-Scan Plus</tradeName>
    <deviceName>B-Scan Plus</deviceName>
    <manufacturerName>Accutome Inc. DBA Keeler USA</manufacturerName>
    <manufacturerSrn>US-MF-000036181</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24-6100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:19.857Z</lastUpdated>
  </row>
  <row>
    <udiDi>00897826002024</udiDi>
    <basicUdiDi>B-00897826002024</basicUdiDi>
    <tradeName>A-Scan Plus Connect</tradeName>
    <deviceName>A-Scan Plus Connect</deviceName>
    <manufacturerName>Accutome Inc. DBA Keeler USA</manufacturerName>
    <manufacturerSrn>US-MF-000036181</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24-4400</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:19.059Z</lastUpdated>
  </row>
  <row>
    <udiDi>00897826002017</udiDi>
    <basicUdiDi>B-00897826002017</basicUdiDi>
    <tradeName>PachPen</tradeName>
    <deviceName>PachPen</deviceName>
    <manufacturerName>Accutome Inc. DBA Keeler USA</manufacturerName>
    <manufacturerSrn>US-MF-000036181</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q0299</emdnCode>
    <emdnDescription>OPHTHALMIC DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24-5100</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:18.270Z</lastUpdated>
  </row>
  <row>
    <udiDi>00897826002000</udiDi>
    <basicUdiDi>B-00897826002000</basicUdiDi>
    <tradeName>AccuPen</tradeName>
    <deviceName>AccuPen</deviceName>
    <manufacturerName>Accutome Inc. DBA Keeler USA</manufacturerName>
    <manufacturerSrn>US-MF-000036181</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12120122</emdnCode>
    <emdnDescription>TONOMETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>24-3000</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T13:03:17.462Z</lastUpdated>
  </row>
</eudamedExport>