<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>+B969SUBH17772</udiDi>
    <basicUdiDi>++B969SURETRACTORLE</basicUdiDi>
    <tradeName>+B969SUBH17772</tradeName>
    <deviceName></deviceName>
    <manufacturerName>B&amp;H Surgical Instrument</manufacturerName>
    <manufacturerSrn>PK-MF-000012820</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021107</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY RETRACTORS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUBH-17772</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-23T06:36:25.580Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435016726842</udiDi>
    <basicUdiDi>184350167cpacks01G8</basicUdiDi>
    <tradeName>Procedure Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Servicio Integral Hospitalario, S.L.U.</manufacturerName>
    <manufacturerSrn>ES-PR-000011724</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021113</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY INSTRUMENT KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>Q4018935/1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:47:19.434Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435016726538</udiDi>
    <basicUdiDi>184350167cpacks01G8</basicUdiDi>
    <tradeName>Procedure Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Servicio Integral Hospitalario, S.L.U.</manufacturerName>
    <manufacturerSrn>ES-PR-000011724</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021113</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY INSTRUMENT KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q4018859/1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:47:06.130Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435016726521</udiDi>
    <basicUdiDi>184350167bpacks01FM</basicUdiDi>
    <tradeName>Bundled Procedure Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Servicio Integral Hospitalario, S.L.U.</manufacturerName>
    <manufacturerSrn>ES-PR-000011724</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021113</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY INSTRUMENT KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Q4018858/1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:47:05.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>08435016726439</udiDi>
    <basicUdiDi>184350167bpacks02FP</basicUdiDi>
    <tradeName>Procedure Pack</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Servicio Integral Hospitalario, S.L.U.</manufacturerName>
    <manufacturerSrn>ES-PR-000011724</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q021113</emdnCode>
    <emdnDescription>OPHTHALMIC SURGERY INSTRUMENT KITS, SINGLE-USE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>900050/GP03</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T19:45:17.685Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516103228</udiDi>
    <basicUdiDi>0840516100003Z</basicUdiDi>
    <tradeName>Peribulbar Needle [Atkinson] 27g X 22mm (7/8")</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>0001C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:06:14.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516103235</udiDi>
    <basicUdiDi>0840516100003Z</basicUdiDi>
    <tradeName>Retrobulbar Needle [Atkinson] 27g X 38mm (1 1/2")</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>0001H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:06:14.190Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516103242</udiDi>
    <basicUdiDi>0840516100003Z</basicUdiDi>
    <tradeName>Peribulbar Needle [Atkinson] 25g X 16mm (5/8")</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>0003A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:06:14.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516103259</udiDi>
    <basicUdiDi>0840516100003Z</basicUdiDi>
    <tradeName>Peribulbar Needle [Atkinson] 25g X 22mm (7/8")</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>0003C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:06:14.165Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516103266</udiDi>
    <basicUdiDi>0840516100003Z</basicUdiDi>
    <tradeName>Peribulbar Needle [Atkinson] 25g X 32mm (1 1/4")</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>0003F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:06:14.151Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516103273</udiDi>
    <basicUdiDi>0840516100003Z</basicUdiDi>
    <tradeName>Retrobulbar Needle [Atkinson] 25g X 38mm (1 1/2")</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>0003H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:06:14.133Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516103297</udiDi>
    <basicUdiDi>0840516100003Z</basicUdiDi>
    <tradeName>Peribulbar Needle [Atkinson] 23g X 16mm (5/8")</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>0004A</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:06:14.115Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516103303</udiDi>
    <basicUdiDi>0840516100003Z</basicUdiDi>
    <tradeName>Peribulbar Needle [Atkinson] 23g X 22mm (7/8")</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>0004C</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:06:14.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516103310</udiDi>
    <basicUdiDi>0840516100003Z</basicUdiDi>
    <tradeName>Peribulbar Needle [Atkinson] 23g X 32mm (1 1/4")</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>0004F</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:06:14.092Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516103327</udiDi>
    <basicUdiDi>0840516100003Z</basicUdiDi>
    <tradeName>Retrobulbar Needle [Atkinson] 23g X 38mm (1 1/2")</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>0004H</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:06:14.074Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516103341</udiDi>
    <basicUdiDi>0840516100003Z</basicUdiDi>
    <tradeName>Retrobulbar Needle [Non Atkinson] 25g X 38mm (1 1/2")</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>0008</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:06:14.058Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516103358</udiDi>
    <basicUdiDi>0840516100003Z</basicUdiDi>
    <tradeName>Retrobulbar Needle [Non Atkinson] 26g X 38mm (1 1/2")</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>0009</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:06:14.045Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516103365</udiDi>
    <basicUdiDi>0840516100003Z</basicUdiDi>
    <tradeName>Retrobulbar Needle [Non Atkinson] 27g X 38mm (1 1/2")</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>0010</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:06:14.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516103372</udiDi>
    <basicUdiDi>0840516100003Z</basicUdiDi>
    <tradeName>Peribulbar Needle [Non Atkinson] 25g 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>0011</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:06:14.018Z</lastUpdated>
  </row>
  <row>
    <udiDi>00840516103389</udiDi>
    <basicUdiDi>0840516100003Z</basicUdiDi>
    <tradeName>Peribulbar Needle [Non Atkinson] 25g X 22mm (7/8")</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>0012</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-22T06:06:14.005Z</lastUpdated>
  </row>
</eudamedExport>