<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00810799038180</udiDi>
    <basicUdiDi>B-00810799038180</basicUdiDi>
    <tradeName>00810799038180</tradeName>
    <deviceName>Knolle-Pearce Vectis Cannula, 3 Irrigating Holes, 23Ga</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>L1713</emdnCode>
    <emdnDescription>OCULAR IRRIGATION OR SUCTION CANNULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC-1105</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:38:12.374Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799038173</udiDi>
    <basicUdiDi>B-00810799038173</basicUdiDi>
    <tradeName>00810799038173</tradeName>
    <deviceName>Knolle Irrigating Cannula, 25Ga</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>L1713</emdnCode>
    <emdnDescription>OCULAR IRRIGATION OR SUCTION CANNULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC-1101</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:38:11.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799038166</udiDi>
    <basicUdiDi>B-00810799038166</basicUdiDi>
    <tradeName>00810799038166</tradeName>
    <deviceName>Knolle Irrigating Cannula, 23Ga</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>L1713</emdnCode>
    <emdnDescription>OCULAR IRRIGATION OR SUCTION CANNULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC-1100</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:38:07.588Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799038159</udiDi>
    <basicUdiDi>B-00810799038159</basicUdiDi>
    <tradeName>00810799038159</tradeName>
    <deviceName>Knolle Irrigating Cannula, 30Ga</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>L1713</emdnCode>
    <emdnDescription>OCULAR IRRIGATION OR SUCTION CANNULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC-1095</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:38:06.771Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799038142</udiDi>
    <basicUdiDi>B-00810799038142</basicUdiDi>
    <tradeName>00810799038142</tradeName>
    <deviceName>Hirschman Irrigating Cannula, Left Handed, 23Ga</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>L1713</emdnCode>
    <emdnDescription>OCULAR IRRIGATION OR SUCTION CANNULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC-1080</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:38:06.071Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799038135</udiDi>
    <basicUdiDi>B-00810799038135</basicUdiDi>
    <tradeName>00810799038135</tradeName>
    <deviceName>Hirschman Irrigating Cannula, Right Handed, 23Ga</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>L1713</emdnCode>
    <emdnDescription>OCULAR IRRIGATION OR SUCTION CANNULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC-1075</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:38:04.376Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799038128</udiDi>
    <basicUdiDi>B-00810799038128</basicUdiDi>
    <tradeName>00810799038128</tradeName>
    <deviceName>Welsh Flat Olive Tip, Straight, 25Ga</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>L1713</emdnCode>
    <emdnDescription>OCULAR IRRIGATION OR SUCTION CANNULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC-1066</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:36:16.202Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799038111</udiDi>
    <basicUdiDi>B-00810799038111</basicUdiDi>
    <tradeName>00810799038111</tradeName>
    <deviceName>Gills Irrigating Cannula, 5, 7, 8, 10 mm, 25Ga, Angled</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>L1713</emdnCode>
    <emdnDescription>OCULAR IRRIGATION OR SUCTION CANNULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC-1065</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:36:15.404Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799038104</udiDi>
    <basicUdiDi>B-00810799038104</basicUdiDi>
    <tradeName>00810799038104</tradeName>
    <deviceName>Bracken A/C  Irrigation Cannula, 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>L1713</emdnCode>
    <emdnDescription>OCULAR IRRIGATION OR SUCTION CANNULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC-1025</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:36:14.591Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799038098</udiDi>
    <basicUdiDi>B-00810799038098</basicUdiDi>
    <tradeName>00810799038098</tradeName>
    <deviceName>Irrigation Cannula 19Ga</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>L1713</emdnCode>
    <emdnDescription>OCULAR IRRIGATION OR SUCTION CANNULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC-1020</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:36:13.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799038081</udiDi>
    <basicUdiDi>B-00810799038081</basicUdiDi>
    <tradeName>00810799038081</tradeName>
    <deviceName>Adaptor Only</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>L1713</emdnCode>
    <emdnDescription>OCULAR IRRIGATION OR SUCTION CANNULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC-1015</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:36:09.788Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799038074</udiDi>
    <basicUdiDi>B-00810799038074</basicUdiDi>
    <tradeName>00810799038074</tradeName>
    <deviceName>Silicon Bulb Only</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>L1713</emdnCode>
    <emdnDescription>OCULAR IRRIGATION OR SUCTION CANNULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC-1010</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:36:08.983Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799038067</udiDi>
    <basicUdiDi>B-00810799038067</basicUdiDi>
    <tradeName>00810799038067</tradeName>
    <deviceName>Bishop Harmon Anterior Chamber Irrigating, Comp. Set</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>L1713</emdnCode>
    <emdnDescription>OCULAR IRRIGATION OR SUCTION CANNULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC-1005</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:36:08.179Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799038050</udiDi>
    <basicUdiDi>B-00810799038050</basicUdiDi>
    <tradeName>00810799038050</tradeName>
    <deviceName>Stephens Bi-Manual Handpiece 23 Ga, Irrigation</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>L1713</emdnCode>
    <emdnDescription>OCULAR IRRIGATION OR SUCTION CANNULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC-1004A</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:36:07.392Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799038043</udiDi>
    <basicUdiDi>B-00810799038043</basicUdiDi>
    <tradeName>00810799038043</tradeName>
    <deviceName>Stephens Bi-Manual Handpiece 23 Ga, Aspiration</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>L1713</emdnCode>
    <emdnDescription>OCULAR IRRIGATION OR SUCTION CANNULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC-1004</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:36:03.398Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799038036</udiDi>
    <basicUdiDi>B-00810799038036</basicUdiDi>
    <tradeName>00810799038036</tradeName>
    <deviceName>Stephens Bi-Manual Handpiece 23 Ga, Complete Set</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>L1713</emdnCode>
    <emdnDescription>OCULAR IRRIGATION OR SUCTION CANNULAS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SC-1003</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:36:02.575Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799037992</udiDi>
    <basicUdiDi>B-00810799037992</basicUdiDi>
    <tradeName>00810799037992</tradeName>
    <deviceName>Stephens Toric Bubble Marker</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>S9-2070</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:36:01.818Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799037985</udiDi>
    <basicUdiDi>B-00810799037985</basicUdiDi>
    <tradeName>00810799037985</tradeName>
    <deviceName>Henderson Lri Marker</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>S9-2065</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:36:00.974Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799037978</udiDi>
    <basicUdiDi>B-00810799037978</basicUdiDi>
    <tradeName>00810799037978</tradeName>
    <deviceName>Henderson Degree Gauge</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>S9-2060</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:35:56.981Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799037961</udiDi>
    <basicUdiDi>B-00810799037961</basicUdiDi>
    <tradeName>00810799037961</tradeName>
    <deviceName>Lri Axis Marker</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>S9-2050</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:35:56.172Z</lastUpdated>
  </row>
</eudamedExport>