<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00840516105345</udiDi>
    <basicUdiDi>08405161500054</basicUdiDi>
    <tradeName>Irrigating Cystotome 25G X 16mm, formed 2mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021101</emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5003AFB</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:56.286Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516105352</udiDi>
    <basicUdiDi>08405161500054</basicUdiDi>
    <tradeName>Irrigating Cystotome 25G X 16mm, formed 2mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021101</emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5003AFT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:56.266Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516105383</udiDi>
    <basicUdiDi>08405161500054</basicUdiDi>
    <tradeName>Irrigating Cystotome 25g X 16mm (5/8"), side cut</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021101</emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5003ASC</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:56.239Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516105390</udiDi>
    <basicUdiDi>08405161500054</basicUdiDi>
    <tradeName>Irrigating Cystotome 25g X 16mm (5/8"), small radius</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021101</emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5003ASR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:56.219Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516105406</udiDi>
    <basicUdiDi>08405161500054</basicUdiDi>
    <tradeName>Irrigating Cystotome 25g X 22mm (7/8"), formed</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021101</emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5003CF</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:56.198Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516105413</udiDi>
    <basicUdiDi>08405161500054</basicUdiDi>
    <tradeName>Irrigating Cystotome 25g X 22mm (7/8"), straight</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021101</emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5003CS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:56.175Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516105420</udiDi>
    <basicUdiDi>08405161500054</basicUdiDi>
    <tradeName>Irrigating Cystotome 23g X 16mm (5/8"), formed</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021101</emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5004AF</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:56.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516105437</udiDi>
    <basicUdiDi>08405161500054</basicUdiDi>
    <tradeName>Irrigating Cystotome 23g X 16mm (5/8"), straight</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021101</emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5004AS</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:56.134Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516105444</udiDi>
    <basicUdiDi>08405161500054</basicUdiDi>
    <tradeName>Irrigating Cystotome [Neuhan] 23G X 25mm, curved</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021101</emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5004DN</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:56.114Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516105451</udiDi>
    <basicUdiDi>08405161500054</basicUdiDi>
    <tradeName>Capsulorhexis Cystotome 27g X 16mm (5/8"), formed</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021101</emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5007</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:56.091Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516105468</udiDi>
    <basicUdiDi>08405161500054</basicUdiDi>
    <tradeName>Capsulorhexis Cystotome 27g X 16mm (5/8"), straight</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021101</emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5007S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:56.069Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516105475</udiDi>
    <basicUdiDi>08405161500054</basicUdiDi>
    <tradeName>Capsulorhexis Cystotome 25g X 16mm (5/8"), formed</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021101</emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:56.049Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516105482</udiDi>
    <basicUdiDi>08405161500054</basicUdiDi>
    <tradeName>Capsulorhexis Cystotome 25g X 16mm (5/8"), straight</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021101</emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5008S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:56.029Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516105499</udiDi>
    <basicUdiDi>08405161500054</basicUdiDi>
    <tradeName>Capsulorhexis Cystotome 23g X 16mm (5/8"), formed</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021101</emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:56.008Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516105505</udiDi>
    <basicUdiDi>08405161500054</basicUdiDi>
    <tradeName>Capsulorhexis Cystotome 23g X 16mm (5/8"), straight</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021101</emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5009S</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:55.986Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516105512</udiDi>
    <basicUdiDi>08405161500054</basicUdiDi>
    <tradeName>Irrigating Sharp Cystotome [KELMAN] 22g X 25mm (1")</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021101</emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:55.967Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516105536</udiDi>
    <basicUdiDi>0840516160005B</basicUdiDi>
    <tradeName>[Giannetti] Posterior Capsulorhexis Cannula</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021101</emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6000G</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:55.932Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516105543</udiDi>
    <basicUdiDi>0840516160005B</basicUdiDi>
    <tradeName>Robins-Kratz Polishing Cannula, 22g</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021101</emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6000-22</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:55.919Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516105550</udiDi>
    <basicUdiDi>0840516160005B</basicUdiDi>
    <tradeName>Capsule Polisher 23g, side port</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021101</emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6001</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:55.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516105567</udiDi>
    <basicUdiDi>0840516160005B</basicUdiDi>
    <tradeName>Capsule Polisher 23g X 22mm (7/8"), side port, angled 2mm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PSI/EYE-KO, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000022109</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021101</emdnCode>
    <emdnDescription>OCCULAR IRRIGATION AND ASPIRATION CANNULAS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>6001-2</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:05:55.892Z</lastUpdated>
  </row>
</eudamedExport>