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    <deviceName>Injection Kit</deviceName>
    <manufacturerName>Vortex Surgical Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022888</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
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    <reference>VS0502C</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:03:11.043Z</lastUpdated>
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    <deviceName>27ga ACTU8 ILM Forceps</deviceName>
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    <manufacturerSrn>US-MF-000022888</manufacturerSrn>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS0744.27</reference>
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    <deviceName>25ga ACTU8 Myopic ILM Forceps</deviceName>
    <manufacturerName>Vortex Surgical Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022888</manufacturerSrn>
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    <reference>VS0744.25-35</reference>
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    <lastUpdated>2026-07-04T16:03:06.251Z</lastUpdated>
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    <deviceName>25ga ACTU8 ILM Forceps</deviceName>
    <manufacturerName>Vortex Surgical Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022888</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
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    <emdnCode>Q020599</emdnCode>
    <emdnDescription>RETINAL DETACHMENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS0744.25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:03:05.455Z</lastUpdated>
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    <udiDi>00810123481224</udiDi>
    <basicUdiDi>B-00810123481224</basicUdiDi>
    <tradeName>00810123481224</tradeName>
    <deviceName>23ga ACTU8 Myopic ILM Forceps</deviceName>
    <manufacturerName>Vortex Surgical Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022888</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q020599</emdnCode>
    <emdnDescription>RETINAL DETACHMENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS0744.23-35</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:03:04.632Z</lastUpdated>
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    <basicUdiDi>B-00810123481217</basicUdiDi>
    <tradeName>00810123481217</tradeName>
    <deviceName>23ga ACTU8 ILM Forceps</deviceName>
    <manufacturerName>Vortex Surgical Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022888</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
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    <emdnDescription>RETINAL DETACHMENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS0744.23</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:03:03.893Z</lastUpdated>
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    <udiDi>00810123481200</udiDi>
    <basicUdiDi>B-00810123481200</basicUdiDi>
    <tradeName>00810123481200</tradeName>
    <deviceName>25ga ACTU8 End Grip Forceps</deviceName>
    <manufacturerName>Vortex Surgical Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022888</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q020599</emdnCode>
    <emdnDescription>RETINAL DETACHMENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS0743.25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:02:59.849Z</lastUpdated>
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    <udiDi>00810123481194</udiDi>
    <basicUdiDi>B-00810123481194</basicUdiDi>
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    <deviceName>23ga ACTU8 End Grip Forceps</deviceName>
    <manufacturerName>Vortex Surgical Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022888</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
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    <emdnDescription>RETINAL DETACHMENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS0743.23</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:02:59.070Z</lastUpdated>
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    <udiDi>00810123481187</udiDi>
    <basicUdiDi>B-00810123481187</basicUdiDi>
    <tradeName>00810123481187</tradeName>
    <deviceName>25ga ACTU8 Myopic Tewari (T2) Forceps</deviceName>
    <manufacturerName>Vortex Surgical Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022888</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q020599</emdnCode>
    <emdnDescription>RETINAL DETACHMENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS0742.25-35</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:02:58.245Z</lastUpdated>
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    <udiDi>00810123481170</udiDi>
    <basicUdiDi>B-00810123481170</basicUdiDi>
    <tradeName>00810123481170</tradeName>
    <deviceName>25ga ACTU8 Tewari (T2) Forceps</deviceName>
    <manufacturerName>Vortex Surgical Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022888</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q020599</emdnCode>
    <emdnDescription>RETINAL DETACHMENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS0742.25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:02:57.427Z</lastUpdated>
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    <udiDi>00810123481163</udiDi>
    <basicUdiDi>B-00810123481163</basicUdiDi>
    <tradeName>00810123481163</tradeName>
    <deviceName>23ga ACTU8 Myopic Tewari (T2) Forceps</deviceName>
    <manufacturerName>Vortex Surgical Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022888</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q020599</emdnCode>
    <emdnDescription>RETINAL DETACHMENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS0742.23-35</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:02:53.425Z</lastUpdated>
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    <udiDi>00810123481156</udiDi>
    <basicUdiDi>B-00810123481156</basicUdiDi>
    <tradeName>00810123481156</tradeName>
    <deviceName>23ga ACTU8 Tewari (T2) Forceps</deviceName>
    <manufacturerName>Vortex Surgical Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022888</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q020599</emdnCode>
    <emdnDescription>RETINAL DETACHMENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS0742.23</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:02:52.640Z</lastUpdated>
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    <udiDi>00810123481149</udiDi>
    <basicUdiDi>B-00810123481149</basicUdiDi>
    <tradeName>00810123481149</tradeName>
    <deviceName>27ga ACTU8 Adaptive Forceps</deviceName>
    <manufacturerName>Vortex Surgical Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022888</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q020599</emdnCode>
    <emdnDescription>RETINAL DETACHMENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS0740.27</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:02:51.829Z</lastUpdated>
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    <udiDi>00810123481132</udiDi>
    <basicUdiDi>B-00810123481132</basicUdiDi>
    <tradeName>00810123481132</tradeName>
    <deviceName>25ga ACTU8 Adaptive Forceps</deviceName>
    <manufacturerName>Vortex Surgical Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022888</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q020599</emdnCode>
    <emdnDescription>RETINAL DETACHMENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS0740.25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:02:51.031Z</lastUpdated>
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    <udiDi>00810123481125</udiDi>
    <basicUdiDi>B-00810123481125</basicUdiDi>
    <tradeName>00810123481125</tradeName>
    <deviceName>23ga ACTU8 Adaptive Forceps</deviceName>
    <manufacturerName>Vortex Surgical Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022888</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q020599</emdnCode>
    <emdnDescription>RETINAL DETACHMENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS0740.23</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:02:47.041Z</lastUpdated>
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    <udiDi>00810123481118</udiDi>
    <basicUdiDi>B-00810123481118</basicUdiDi>
    <tradeName>00810123481118</tradeName>
    <deviceName>27ga ACTU8 Pro-Grip Forceps</deviceName>
    <manufacturerName>Vortex Surgical Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022888</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q020599</emdnCode>
    <emdnDescription>RETINAL DETACHMENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS0713.27</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:02:46.236Z</lastUpdated>
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    <udiDi>00810123481101</udiDi>
    <basicUdiDi>B-00810123481101</basicUdiDi>
    <tradeName>00810123481101</tradeName>
    <deviceName>25ga ACTU8 Pro-Grip Forceps</deviceName>
    <manufacturerName>Vortex Surgical Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022888</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q020599</emdnCode>
    <emdnDescription>RETINAL DETACHMENT DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS0713.25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-04T16:02:45.439Z</lastUpdated>
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    <udiDi>00810123480913</udiDi>
    <basicUdiDi>081012348Forceps9G</basicUdiDi>
    <tradeName>25ga Retractable ILM Membrane Elevator Box of 5</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vortex Surgical Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022888</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS0350.25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:11:00.710Z</lastUpdated>
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    <udiDi>00810123480906</udiDi>
    <basicUdiDi>081012348Forceps9G</basicUdiDi>
    <tradeName>23ga Retractable ILM Membrane Elevator Box of 5</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vortex Surgical Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022888</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS0350.23</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:10:56.249Z</lastUpdated>
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    <udiDi>00810123480890</udiDi>
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    <tradeName>25ga ILM Membrane Elevator Box of 5</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Vortex Surgical Inc</manufacturerName>
    <manufacturerSrn>US-MF-000022888</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VS0300.25</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-06-16T21:10:55.307Z</lastUpdated>
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