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<eudamedExport entity="devices">
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    <basicUdiDi>5050474a00069A4</basicUdiDi>
    <tradeName>MOBILE PATIENT BED</tradeName>
    <deviceName>CATALYS SYSTEM MOBILE PATIENT BED</deviceName>
    <manufacturerName>AMO Manufacturing USA, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000023322</manufacturerSrn>
    <authorisedRepresentativeName>AMO Ireland</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000013513</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q020680</emdnCode>
    <emdnDescription>PHACOEMULSIFICATION DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0160-6000</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:58:38.104Z</lastUpdated>
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    <udiDi>04034393767321</udiDi>
    <basicUdiDi>4034393CPTOPH2B2T</basicUdiDi>
    <tradeName>Augen-OP-Set</tradeName>
    <deviceName>Vitrektomiset Uppsala</deviceName>
    <manufacturerName>Sengewald Klinikprodukte GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000020748</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q020601</emdnCode>
    <emdnDescription>PHACOEMULSIFICATION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>66213366-11</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:24:59.801Z</lastUpdated>
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    <udiDi>04034393100937</udiDi>
    <basicUdiDi>4034393CPTOPH1U6</basicUdiDi>
    <tradeName>Katarakt-Set</tradeName>
    <deviceName>IVOM-Set</deviceName>
    <manufacturerName>Sengewald Klinikprodukte GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000020748</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q020601</emdnCode>
    <emdnDescription>PHACOEMULSIFICATION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>564466</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-30T19:23:55.731Z</lastUpdated>
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    <udiDi>03700512905806</udiDi>
    <basicUdiDi>037005129OPH-PEXJ</basicUdiDi>
    <tradeName>03700512905806</tradeName>
    <deviceName>Ophthalmology irrigation/aspiration tubing lines</deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q020601</emdnCode>
    <emdnDescription>PHACOEMULSIFICATION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01-Geu-Ext</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T15:26:13.832Z</lastUpdated>
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  <row>
    <udiDi>04034393812199</udiDi>
    <basicUdiDi>4034393CPTOPH2A2R</basicUdiDi>
    <tradeName>Katarakt-OP-Set</tradeName>
    <deviceName>Katarakt-Set</deviceName>
    <manufacturerName>Sengewald Klinikprodukte GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000020748</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q020601</emdnCode>
    <emdnDescription>PHACOEMULSIFICATION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>66231699-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-29T19:54:29.008Z</lastUpdated>
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  <row>
    <udiDi>04034393812113</udiDi>
    <basicUdiDi>4034393CPTOPH2A2R</basicUdiDi>
    <tradeName>Katarakt Set</tradeName>
    <deviceName>Katarakt-Set</deviceName>
    <manufacturerName>Sengewald Klinikprodukte GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000020748</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q020601</emdnCode>
    <emdnDescription>PHACOEMULSIFICATION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>66233050-02</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-27T22:07:41.689Z</lastUpdated>
  </row>
  <row>
    <udiDi>04034393812076</udiDi>
    <basicUdiDi>4034393CPTOPH2A2R</basicUdiDi>
    <tradeName>Katarakt-OP-Set</tradeName>
    <deviceName>Katarakt-Set</deviceName>
    <manufacturerName>Sengewald Klinikprodukte GmbH</manufacturerName>
    <manufacturerSrn>DE-PR-000020748</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q020601</emdnCode>
    <emdnDescription>PHACOEMULSIFICATION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>66220591-08</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-24T19:56:12.393Z</lastUpdated>
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  <row>
    <udiDi>10757770058867</udiDi>
    <basicUdiDi>0310119B1033ZD</basicUdiDi>
    <tradeName>Stellaris Elite</tradeName>
    <deviceName>Stellaris Elite Procedure Packs</deviceName>
    <manufacturerName>Bausch &amp; Lomb Incorporated</manufacturerName>
    <manufacturerSrn>US-MF-000001029</manufacturerSrn>
    <authorisedRepresentativeName>Bausch &amp; Lomb GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006810</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q020680</emdnCode>
    <emdnDescription>PHACOEMULSIFICATION DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BL5115-3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-23T08:49:20.654Z</lastUpdated>
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  <row>
    <udiDi>03700512905813</udiDi>
    <basicUdiDi>037005129OPH-PEXJ</basicUdiDi>
    <tradeName>03700512905813</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q020601</emdnCode>
    <emdnDescription>PHACOEMULSIFICATION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>02-IA-Phako</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T17:58:33.677Z</lastUpdated>
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  <row>
    <udiDi>03700512905820</udiDi>
    <basicUdiDi>037005129OPH-PEXJ</basicUdiDi>
    <tradeName>03700512905820</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q020601</emdnCode>
    <emdnDescription>PHACOEMULSIFICATION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-13-002</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T17:58:33.652Z</lastUpdated>
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  <row>
    <udiDi>03700512905943</udiDi>
    <basicUdiDi>037005129OPH-PEXJ</basicUdiDi>
    <tradeName>03700512905943</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q020601</emdnCode>
    <emdnDescription>PHACOEMULSIFICATION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-13-019</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T17:58:33.502Z</lastUpdated>
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  <row>
    <udiDi>03700512905950</udiDi>
    <basicUdiDi>037005129OPH-PEXJ</basicUdiDi>
    <tradeName>03700512905950</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q020601</emdnCode>
    <emdnDescription>PHACOEMULSIFICATION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-13-003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T17:58:33.472Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512905967</udiDi>
    <basicUdiDi>037005129OPH-PEXJ</basicUdiDi>
    <tradeName>03700512905967</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q020601</emdnCode>
    <emdnDescription>PHACOEMULSIFICATION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-13-004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T17:58:33.447Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512905974</udiDi>
    <basicUdiDi>037005129OPH-PEXJ</basicUdiDi>
    <tradeName>03700512905974</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q020601</emdnCode>
    <emdnDescription>PHACOEMULSIFICATION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-13-009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T17:58:33.430Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512905981</udiDi>
    <basicUdiDi>037005129OPH-PEXJ</basicUdiDi>
    <tradeName>03700512905981</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q020601</emdnCode>
    <emdnDescription>PHACOEMULSIFICATION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-13-022</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T17:58:33.397Z</lastUpdated>
  </row>
  <row>
    <udiDi>03700512905998</udiDi>
    <basicUdiDi>037005129OPH-PEXJ</basicUdiDi>
    <tradeName>03700512905998</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q020601</emdnCode>
    <emdnDescription>PHACOEMULSIFICATION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-13-017</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T17:58:33.374Z</lastUpdated>
  </row>
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    <udiDi>03700512906643</udiDi>
    <basicUdiDi>037005129OPH-PEXJ</basicUdiDi>
    <tradeName>03700512906643</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q020601</emdnCode>
    <emdnDescription>PHACOEMULSIFICATION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1188</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T17:58:16.162Z</lastUpdated>
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    <udiDi>03700512915966</udiDi>
    <basicUdiDi>037005129OPH-PEXJ</basicUdiDi>
    <tradeName>03700512915966</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q020601</emdnCode>
    <emdnDescription>PHACOEMULSIFICATION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-13-004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T17:58:15.293Z</lastUpdated>
  </row>
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    <udiDi>03700512915973</udiDi>
    <basicUdiDi>037005129OPH-PEXJ</basicUdiDi>
    <tradeName>03700512915973</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q020601</emdnCode>
    <emdnDescription>PHACOEMULSIFICATION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-13-009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T17:58:15.262Z</lastUpdated>
  </row>
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    <udiDi>03700512925804</udiDi>
    <basicUdiDi>037005129OPH-PEXJ</basicUdiDi>
    <tradeName>03700512925804</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Promepla SAM</manufacturerName>
    <manufacturerSrn>MC-MF-000015769</manufacturerSrn>
    <authorisedRepresentativeName>Promepla Group S.à r.l.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>LU-AR-000013458</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q020601</emdnCode>
    <emdnDescription>PHACOEMULSIFICATION SETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>01-Geu-Ext</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-21T17:58:13.470Z</lastUpdated>
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