<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00810061911869</udiDi>
    <basicUdiDi>B-00810061911869</basicUdiDi>
    <tradeName>00810061911869</tradeName>
    <deviceName>Barraquer Wire Speculum, Adult 15 mm</deviceName>
    <manufacturerName>Stephens Instruments</manufacturerName>
    <manufacturerSrn>US-MF-000030661</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L170102</emdnCode>
    <emdnDescription>OCULAR AND ENDOCULAR RETRACTORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S1-1005H</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:02:03.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810061911562</udiDi>
    <basicUdiDi>B-00810061911562</basicUdiDi>
    <tradeName>00810061911562</tradeName>
    <deviceName>Stromal S Marker, 45 Degree Angle</deviceName>
    <manufacturerName>Stephens Instruments</manufacturerName>
    <manufacturerSrn>US-MF-000030661</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q020203</emdnCode>
    <emdnDescription>CORNEAL MARKERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S9-1905</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:02:02.942Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810061911555</udiDi>
    <basicUdiDi>B-00810061911555</basicUdiDi>
    <tradeName>00810061911555</tradeName>
    <deviceName>Stromal S Marker, Flat Orientation</deviceName>
    <manufacturerName>Stephens Instruments</manufacturerName>
    <manufacturerSrn>US-MF-000030661</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q020203</emdnCode>
    <emdnDescription>CORNEAL MARKERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S9-1900</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:01:58.939Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810061911548</udiDi>
    <basicUdiDi>B-00810061911548</basicUdiDi>
    <tradeName>00810061911548</tradeName>
    <deviceName>Stromal F Marker, 45 Degree Angle</deviceName>
    <manufacturerName>Stephens Instruments</manufacturerName>
    <manufacturerSrn>US-MF-000030661</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q020203</emdnCode>
    <emdnDescription>CORNEAL MARKERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S9-1805</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:01:58.138Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810061911531</udiDi>
    <basicUdiDi>B-00810061911531</basicUdiDi>
    <tradeName>00810061911531</tradeName>
    <deviceName>Stromal F Marker, Flat Orientation</deviceName>
    <manufacturerName>Stephens Instruments</manufacturerName>
    <manufacturerSrn>US-MF-000030661</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q020203</emdnCode>
    <emdnDescription>CORNEAL MARKERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S9-1800</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:01:57.342Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810061911265</udiDi>
    <basicUdiDi>B-00810061911265</basicUdiDi>
    <tradeName>00810061911265</tradeName>
    <deviceName>ACCUFLO, STERILE, X-LARGE</deviceName>
    <manufacturerName>Stephens Instruments</manufacturerName>
    <manufacturerSrn>US-MF-000030661</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q020703</emdnCode>
    <emdnDescription>LACRIMAL DUCT PLUGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3003</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:01:56.535Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810061911258</udiDi>
    <basicUdiDi>B-00810061911258</basicUdiDi>
    <tradeName>00810061911258</tradeName>
    <deviceName>ACCUFLO, STERILE, LARGE</deviceName>
    <manufacturerName>Stephens Instruments</manufacturerName>
    <manufacturerSrn>US-MF-000030661</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q020703</emdnCode>
    <emdnDescription>LACRIMAL DUCT PLUGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3002</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:01:52.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810061911241</udiDi>
    <basicUdiDi>B-00810061911241</basicUdiDi>
    <tradeName>00810061911241</tradeName>
    <deviceName>ACCUFLO, STERILE, MEDIUM</deviceName>
    <manufacturerName>Stephens Instruments</manufacturerName>
    <manufacturerSrn>US-MF-000030661</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q020703</emdnCode>
    <emdnDescription>LACRIMAL DUCT PLUGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:01:51.734Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810061911234</udiDi>
    <basicUdiDi>B-00810061911234</basicUdiDi>
    <tradeName>00810061911234</tradeName>
    <deviceName>ACCUFLO, STERILE, SMALL</deviceName>
    <manufacturerName>Stephens Instruments</manufacturerName>
    <manufacturerSrn>US-MF-000030661</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q020703</emdnCode>
    <emdnDescription>LACRIMAL DUCT PLUGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3000</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:01:50.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810061911227</udiDi>
    <basicUdiDi>B-00810061911227</basicUdiDi>
    <tradeName>00810061911227</tradeName>
    <deviceName>COMFORT TIP, STERILE, LARGE</deviceName>
    <manufacturerName>Stephens Instruments</manufacturerName>
    <manufacturerSrn>US-MF-000030661</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q020703</emdnCode>
    <emdnDescription>LACRIMAL DUCT PLUGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2010</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:01:50.132Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810061911210</udiDi>
    <basicUdiDi>B-00810061911210</basicUdiDi>
    <tradeName>00810061911210</tradeName>
    <deviceName>COMFORT TIP, STERILE, MEDIUM</deviceName>
    <manufacturerName>Stephens Instruments</manufacturerName>
    <manufacturerSrn>US-MF-000030661</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q020703</emdnCode>
    <emdnDescription>LACRIMAL DUCT PLUGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2008</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:01:46.135Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810061911203</udiDi>
    <basicUdiDi>B-00810061911203</basicUdiDi>
    <tradeName>00810061911203</tradeName>
    <deviceName>COMFORT TIP, STERILE, SMALL</deviceName>
    <manufacturerName>Stephens Instruments</manufacturerName>
    <manufacturerSrn>US-MF-000030661</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q020703</emdnCode>
    <emdnDescription>LACRIMAL DUCT PLUGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2005</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:01:45.328Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810061911197</udiDi>
    <basicUdiDi>B-00810061911197</basicUdiDi>
    <tradeName>00810061911197</tradeName>
    <deviceName>COMFORT TIP, STERILE, X-SMALL</deviceName>
    <manufacturerName>Stephens Instruments</manufacturerName>
    <manufacturerSrn>US-MF-000030661</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q020703</emdnCode>
    <emdnDescription>LACRIMAL DUCT PLUGS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2003</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:01:44.538Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810061910763</udiDi>
    <basicUdiDi>B-00810061910763</basicUdiDi>
    <tradeName>00810061910763</tradeName>
    <deviceName>Plastic Instrument Tray, 6.0X10.0X1.5 (Double Level)</deviceName>
    <manufacturerName>Stephens Instruments</manufacturerName>
    <manufacturerSrn>US-MF-000030661</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L80</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T2-0005</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:01:43.725Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810061910756</udiDi>
    <basicUdiDi>B-00810061910756</basicUdiDi>
    <tradeName>00810061910756</tradeName>
    <deviceName>Plastic Instrument Tray, 2.5X6.0X0.75 (Silicone Bars)</deviceName>
    <manufacturerName>Stephens Instruments</manufacturerName>
    <manufacturerSrn>US-MF-000030661</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L80</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T1-0007</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:01:39.718Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810061910749</udiDi>
    <basicUdiDi>B-00810061910749</basicUdiDi>
    <tradeName>00810061910749</tradeName>
    <deviceName>Plastic Instrument Tray, 6.0X10.0X0.75</deviceName>
    <manufacturerName>Stephens Instruments</manufacturerName>
    <manufacturerSrn>US-MF-000030661</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L80</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T1-0005</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:01:38.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810061910732</udiDi>
    <basicUdiDi>B-00810061910732</basicUdiDi>
    <tradeName>00810061910732</tradeName>
    <deviceName>Plastic Instrument Tray, 4.0X7.5X0.75</deviceName>
    <manufacturerName>Stephens Instruments</manufacturerName>
    <manufacturerSrn>US-MF-000030661</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L80</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T1-0004</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:01:38.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810061910725</udiDi>
    <basicUdiDi>B-00810061910725</basicUdiDi>
    <tradeName>00810061910725</tradeName>
    <deviceName>Plastic Instrument Tray, 4.0X6.5X0.75</deviceName>
    <manufacturerName>Stephens Instruments</manufacturerName>
    <manufacturerSrn>US-MF-000030661</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L80</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T1-0003</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:01:37.317Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810061910718</udiDi>
    <basicUdiDi>B-00810061910718</basicUdiDi>
    <tradeName>00810061910718</tradeName>
    <deviceName>Plastic Instrument Tray, 2.5X7.5X0.75</deviceName>
    <manufacturerName>Stephens Instruments</manufacturerName>
    <manufacturerSrn>US-MF-000030661</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L80</emdnCode>
    <emdnDescription>SURGICAL INSTRUMENTS, REUSABLE - VARIOUS ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T1-0002</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:01:22.065Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810061910701</udiDi>
    <basicUdiDi>B-00810061910701</basicUdiDi>
    <tradeName>00810061910701</tradeName>
    <deviceName>Plastic Instrument Tray, 2.5X6.0X0.75</deviceName>
    <manufacturerName>Stephens Instruments</manufacturerName>
    <manufacturerSrn>US-MF-000030661</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>L1799</emdnCode>
    <emdnDescription>OPHTHALMOLOGY INSTRUMENTS, REUSABLE- OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>T1-0001</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:01:21.281Z</lastUpdated>
  </row>
</eudamedExport>