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<eudamedExport entity="devices">
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    <udiDi>00810799030542</udiDi>
    <basicUdiDi>B-00810799030542</basicUdiDi>
    <tradeName>00810799030542</tradeName>
    <deviceName>Barraquer Wire Speculum, Child, Nasal, 12 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>S1-1011</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:06:05.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030535</udiDi>
    <basicUdiDi>B-00810799030535</basicUdiDi>
    <tradeName>00810799030535</tradeName>
    <deviceName>Barraquer Wire Speculum Solid, 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>S1-1010</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:06:03.302Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030528</udiDi>
    <basicUdiDi>B-00810799030528</basicUdiDi>
    <tradeName>00810799030528</tradeName>
    <deviceName>Barraquer Wire Speculum Solid, Infant</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>S1-1009</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:06:01.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030511</udiDi>
    <basicUdiDi>B-00810799030511</basicUdiDi>
    <tradeName>00810799030511</tradeName>
    <deviceName>Pierse Eye 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>S1-1008</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:06:00.902Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030504</udiDi>
    <basicUdiDi>B-00810799030504</basicUdiDi>
    <tradeName>00810799030504</tradeName>
    <deviceName>Barraquer Wire Speculum, 18 mm 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>S1-1006</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:05:59.309Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030498</udiDi>
    <basicUdiDi>B-00810799030498</basicUdiDi>
    <tradeName>00810799030498</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>S1-1005</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:05:56.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030481</udiDi>
    <basicUdiDi>B-00810799030481</basicUdiDi>
    <tradeName>00810799030481</tradeName>
    <deviceName>Slade Lasik 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>S1-1003</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:05:55.307Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030474</udiDi>
    <basicUdiDi>B-00810799030474</basicUdiDi>
    <tradeName>00810799030474</tradeName>
    <deviceName>Barraquer Wire Speculum, Child, 12 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>S1-1002</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:05:54.507Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030467</udiDi>
    <basicUdiDi>B-00810799030467</basicUdiDi>
    <tradeName>00810799030467</tradeName>
    <deviceName>Barraquer Wire Speculum, Infant</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>S1-1001</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:05:52.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030450</udiDi>
    <basicUdiDi>B-00810799030450</basicUdiDi>
    <tradeName>00810799030450</tradeName>
    <deviceName>Newell Lid Retractor, Pair</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>S1-1000</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:05:50.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030443</udiDi>
    <basicUdiDi>B-00810799030443</basicUdiDi>
    <tradeName>00810799030443</tradeName>
    <deviceName>Handle, 3-Piece For Beaver</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>L170203</emdnCode>
    <emdnDescription>FORCEPS FOR HANDLING DEVICES FOR OPHTHALMIC USE, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD-1036</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:05:48.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030436</udiDi>
    <basicUdiDi>B-00810799030436</basicUdiDi>
    <tradeName>00810799030436</tradeName>
    <deviceName>Handle No. 4</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>L170203</emdnCode>
    <emdnDescription>FORCEPS FOR HANDLING DEVICES FOR OPHTHALMIC USE, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD-1010</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:05:48.093Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030429</udiDi>
    <basicUdiDi>B-00810799030429</basicUdiDi>
    <tradeName>00810799030429</tradeName>
    <deviceName>Handle No. 7</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>L170203</emdnCode>
    <emdnDescription>FORCEPS FOR HANDLING DEVICES FOR OPHTHALMIC USE, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD-1005</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:05:46.508Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030245</udiDi>
    <basicUdiDi>B-00810799030245</basicUdiDi>
    <tradeName>Lacrivera</tradeName>
    <deviceName>VERAPLUG FLOW BULK NON-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>BVF-1004</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:05:44.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030412</udiDi>
    <basicUdiDi>B-00810799030412</basicUdiDi>
    <tradeName>00810799030412</tradeName>
    <deviceName>Handle No. 3</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>L170203</emdnCode>
    <emdnDescription>FORCEPS FOR HANDLING DEVICES FOR OPHTHALMIC USE, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AD-1000</reference>
    <placedOnMarketCountry>Norway</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:05:42.489Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030221</udiDi>
    <basicUdiDi>B-00810799030221</basicUdiDi>
    <tradeName>Lacrivera</tradeName>
    <deviceName>VERAPLUG FLOW BULK NON-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>BVF-1002</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:05:41.697Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030238</udiDi>
    <basicUdiDi>B-00810799030238</basicUdiDi>
    <tradeName>Lacrivera</tradeName>
    <deviceName>VERAPLUG FLOW BULK NON-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>BVF-1003</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:05:40.102Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030214</udiDi>
    <basicUdiDi>B-00810799030214</basicUdiDi>
    <tradeName>Lacrivera</tradeName>
    <deviceName>VERAPLUG FLOW BULK NON-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>BVF-1001</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:05:24.868Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030160</udiDi>
    <basicUdiDi>B-00810799030160</basicUdiDi>
    <tradeName>Lacrivera</tradeName>
    <deviceName>VERAPLUG FLOW - STERILE PRE-LOADED PERFORATED PLUG, 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>VFL-1004</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:05:23.236Z</lastUpdated>
  </row>
  <row>
    <udiDi>00810799030153</udiDi>
    <basicUdiDi>B-00810799030153</basicUdiDi>
    <tradeName>Lacrivera</tradeName>
    <deviceName>VERAPLUG FLOW - STERILE PRE-LOADED PERFORATED PLUG, 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>VFL-1003</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:05:22.446Z</lastUpdated>
  </row>
</eudamedExport>