<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00810799030740</udiDi>
    <basicUdiDi>B-00810799030740</basicUdiDi>
    <tradeName>00810799030740</tradeName>
    <deviceName>Cook Speculum, 3 mm, Solid Blades</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>S1-1052</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:08:26.645Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030733</udiDi>
    <basicUdiDi>B-00810799030733</basicUdiDi>
    <tradeName>00810799030733</tradeName>
    <deviceName>Sauer Speculum,  Modified, Premature, Solid Blades</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>S1-1045</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:08:25.842Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030726</udiDi>
    <basicUdiDi>B-00810799030726</basicUdiDi>
    <tradeName>00810799030726</tradeName>
    <deviceName>Sauer Speculum, Infant, Solid Blades</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>S1-1040</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:08:25.040Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030719</udiDi>
    <basicUdiDi>B-00810799030719</basicUdiDi>
    <tradeName>00810799030719</tradeName>
    <deviceName>Alfonzo Speculum</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>S1-1029</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:08:20.234Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030702</udiDi>
    <basicUdiDi>B-00810799030702</basicUdiDi>
    <tradeName>00810799030702</tradeName>
    <deviceName>Lieberman Eye Speculum, Solid Blades</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>S1-1028</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:08:19.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030696</udiDi>
    <basicUdiDi>B-00810799030696</basicUdiDi>
    <tradeName>00810799030696</tradeName>
    <deviceName>Lieberman  Adjustable Eye Speculum, V-Shaped Wire</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>S1-1027</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:08:18.633Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030689</udiDi>
    <basicUdiDi>B-00810799030689</basicUdiDi>
    <tradeName>00810799030689</tradeName>
    <deviceName>Lieberman  Adjustable Eye Speculum, K-Shaped Wire</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>S1-1026</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:08:17.849Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030672</udiDi>
    <basicUdiDi>B-00810799030672</basicUdiDi>
    <tradeName>00810799030672</tradeName>
    <deviceName>Stephens Irrigating Speculum</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>S1-1025</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:08:13.837Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030665</udiDi>
    <basicUdiDi>B-00810799030665</basicUdiDi>
    <tradeName>00810799030665</tradeName>
    <deviceName>Stephens V-Shaped Wire Speculum</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>S1-1022</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:08:13.039Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030658</udiDi>
    <basicUdiDi>B-00810799030658</basicUdiDi>
    <tradeName>00810799030658</tradeName>
    <deviceName>Grandon-Barraquer Wire Speculum w/ Notches</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>S1-1020</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:08:12.230Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030641</udiDi>
    <basicUdiDi>B-00810799030641</basicUdiDi>
    <tradeName>00810799030641</tradeName>
    <deviceName>Kratz Wing Speculum, Fenestrated Blades</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>S1-1018</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:08:11.426Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030634</udiDi>
    <basicUdiDi>B-00810799030634</basicUdiDi>
    <tradeName>00810799030634</tradeName>
    <deviceName>Kratz Wing Speculum, w/o Bar, Child</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>S1-1017</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:08:06.630Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030627</udiDi>
    <basicUdiDi>B-00810799030627</basicUdiDi>
    <tradeName>00810799030627</tradeName>
    <deviceName>Kratz Wing Speculum, w/o Bar, Adult</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>S1-1016</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:08:05.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030610</udiDi>
    <basicUdiDi>B-00810799030610</basicUdiDi>
    <tradeName>00810799030610</tradeName>
    <deviceName>Barraquer Wire Speculum Solid, Adult</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>S1-1015</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:08:05.026Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030603</udiDi>
    <basicUdiDi>B-00810799030603</basicUdiDi>
    <tradeName>00810799030603</tradeName>
    <deviceName>Liberman  Adjustable Speculum, V Shaped Wire</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>S1-1014V</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:08:04.243Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030597</udiDi>
    <basicUdiDi>B-00810799030597</basicUdiDi>
    <tradeName>00810799030597</tradeName>
    <deviceName>Liberman  Adjustable Speculum, Solid Blade, Universal</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>S1-1014U</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:06:13.719Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030580</udiDi>
    <basicUdiDi>B-00810799030580</basicUdiDi>
    <tradeName>00810799030580</tradeName>
    <deviceName>Liberman  Adjustable Speculum, Solid Blade</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>S1-1014S</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:06:12.111Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030573</udiDi>
    <basicUdiDi>B-00810799030573</basicUdiDi>
    <tradeName>00810799030573</tradeName>
    <deviceName>Liberman  Adjustable Speculum, K Shaped Wire</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>S1-1014K</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:06:09.711Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030566</udiDi>
    <basicUdiDi>B-00810799030566</basicUdiDi>
    <tradeName>00810799030566</tradeName>
    <deviceName>Barraquer Speculum, Solid, Adult</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>S1-1013</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:06:08.109Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030559</udiDi>
    <basicUdiDi>B-00810799030559</basicUdiDi>
    <tradeName>00810799030559</tradeName>
    <deviceName>Barraquer Wire Speculum, Adult, Nasal, 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>S1-1012</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:06:07.306Z</lastUpdated>
  </row>
</eudamedExport>