<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00810799033147</udiDi>
    <basicUdiDi>B-00810799033147</basicUdiDi>
    <tradeName>00810799033147</tradeName>
    <deviceName>Machat Lasik Retreatment</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>L1711</emdnCode>
    <emdnDescription>OPHTHALMOLOGY HOOKS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S4-1630</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:18:11.391Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799033130</udiDi>
    <basicUdiDi>B-00810799033130</basicUdiDi>
    <tradeName>00810799033130</tradeName>
    <deviceName>Ku Lasik Flap Elevator/Manipulator</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>S4-1625</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:18:07.387Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799033123</udiDi>
    <basicUdiDi>B-00810799033123</basicUdiDi>
    <tradeName>00810799033123</tradeName>
    <deviceName>Herzing Lasik Elevator/Retractor</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>S4-1620</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:18:06.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799033116</udiDi>
    <basicUdiDi>B-00810799033116</basicUdiDi>
    <tradeName>00810799033116</tradeName>
    <deviceName>Slade Lasik Retreatment</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>L1705</emdnCode>
    <emdnDescription>OPHTHALMOLOGY PROBES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S4-1615</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:18:05.000Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799033109</udiDi>
    <basicUdiDi>B-00810799033109</basicUdiDi>
    <tradeName>00810799033109</tradeName>
    <deviceName>Slade Flap Spatula, Blunt</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>L1706</emdnCode>
    <emdnDescription>OPHTHALMOLOGY SPATULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S4-1610</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:18:04.223Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799033093</udiDi>
    <basicUdiDi>B-00810799033093</basicUdiDi>
    <tradeName>00810799033093</tradeName>
    <deviceName>Seibel Intralase Separator/Elevator</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>L1711</emdnCode>
    <emdnDescription>OPHTHALMOLOGY HOOKS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S4-1609</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:16:16.159Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799033086</udiDi>
    <basicUdiDi>B-00810799033086</basicUdiDi>
    <tradeName>00810799033086</tradeName>
    <deviceName>Fukasaku Lasik Spatula</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>L1706</emdnCode>
    <emdnDescription>OPHTHALMOLOGY SPATULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S4-1605</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:16:15.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799033079</udiDi>
    <basicUdiDi>B-00810799033079</basicUdiDi>
    <tradeName>00810799033079</tradeName>
    <deviceName>Guimaraes Lasik Spatula</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>L1706</emdnCode>
    <emdnDescription>OPHTHALMOLOGY SPATULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S4-1600</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:16:14.558Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799033062</udiDi>
    <basicUdiDi>B-00810799033062</basicUdiDi>
    <tradeName>00810799033062</tradeName>
    <deviceName>Anis Ball Tip Manipulator</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>L1711</emdnCode>
    <emdnDescription>OPHTHALMOLOGY HOOKS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S4-1570</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:16:13.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799033055</udiDi>
    <basicUdiDi>B-00810799033055</basicUdiDi>
    <tradeName>00810799033055</tradeName>
    <deviceName>Conner Wand, Curved</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>L1711</emdnCode>
    <emdnDescription>OPHTHALMOLOGY HOOKS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S4-1565</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:16:09.755Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799033048</udiDi>
    <basicUdiDi>B-00810799033048</basicUdiDi>
    <tradeName>00810799033048</tradeName>
    <deviceName>Conner Wand, Straight</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>L1705</emdnCode>
    <emdnDescription>OPHTHALMOLOGY PROBES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S4-1560</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:16:08.951Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799033031</udiDi>
    <basicUdiDi>B-00810799033031</basicUdiDi>
    <tradeName>00810799033031</tradeName>
    <deviceName>Chang Microfinger Chopper</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>L1706</emdnCode>
    <emdnDescription>OPHTHALMOLOGY SPATULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S4-1559</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:16:08.155Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799033024</udiDi>
    <basicUdiDi>B-00810799033024</basicUdiDi>
    <tradeName>00810799033024</tradeName>
    <deviceName>Chang Combination Microfinger Horizontal &amp; Quick Chop</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>L1705</emdnCode>
    <emdnDescription>OPHTHALMOLOGY PROBES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S4-1558</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:16:07.350Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799033017</udiDi>
    <basicUdiDi>B-00810799033017</basicUdiDi>
    <tradeName>00810799033017</tradeName>
    <deviceName>Seibel Nucleus Chopper</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>L1705</emdnCode>
    <emdnDescription>OPHTHALMOLOGY PROBES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S4-1557</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:16:03.345Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799033000</udiDi>
    <basicUdiDi>B-00810799033000</basicUdiDi>
    <tradeName>00810799033000</tradeName>
    <deviceName>Rosen Phaco Splitter</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>L1705</emdnCode>
    <emdnDescription>OPHTHALMOLOGY PROBES, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S4-1556</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:16:02.550Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799032997</udiDi>
    <basicUdiDi>B-00810799032997</basicUdiDi>
    <tradeName>00810799032997</tradeName>
    <deviceName>Chang-Seibel Chopper</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>L1706</emdnCode>
    <emdnDescription>OPHTHALMOLOGY SPATULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S4-1554</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:16:01.741Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799032980</udiDi>
    <basicUdiDi>B-00810799032980</basicUdiDi>
    <tradeName>00810799032980</tradeName>
    <deviceName>He Hook Chopper</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>L1706</emdnCode>
    <emdnDescription>OPHTHALMOLOGY SPATULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S4-1553</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:16:00.945Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799032973</udiDi>
    <basicUdiDi>B-00810799032973</basicUdiDi>
    <tradeName>00810799032973</tradeName>
    <deviceName>Koch Stop And Chop Manipulator</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>L1711</emdnCode>
    <emdnDescription>OPHTHALMOLOGY HOOKS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S4-1552</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:15:56.954Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799032966</udiDi>
    <basicUdiDi>B-00810799032966</basicUdiDi>
    <tradeName>00810799032966</tradeName>
    <deviceName>Nichamin Quick Chop Verticle Chopper</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>L1706</emdnCode>
    <emdnDescription>OPHTHALMOLOGY SPATULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S4-1551</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:15:56.145Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799032959</udiDi>
    <basicUdiDi>B-00810799032959</basicUdiDi>
    <tradeName>00810799032959</tradeName>
    <deviceName>Nagahara Phaco Chopper</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>L1706</emdnCode>
    <emdnDescription>OPHTHALMOLOGY SPATULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S4-1550</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:15:55.340Z</lastUpdated>
  </row>
</eudamedExport>