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    <tradeName>Prime-Dent Light Cure Hybrid Composite</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Prime Dental Manufacturing</manufacturerName>
    <manufacturerSrn>US-MF-000008807</manufacturerSrn>
    <authorisedRepresentativeName>MedEnvoy Global BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000024028</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Q01010103</emdnCode>
    <emdnDescription>DENTAL RESTORATIVE COMPOSITES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001-001A1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:07:55.917Z</lastUpdated>
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    <basicUdiDi>B-00816063020165</basicUdiDi>
    <tradeName>Invisalign System</tradeName>
    <deviceName>Invisalign System</deviceName>
    <manufacturerName>Align Technology Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000000744</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010499</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>8800</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:01:03.552Z</lastUpdated>
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    <basicUdiDi>B-00816063020028</basicUdiDi>
    <tradeName>Vivera Retainer</tradeName>
    <deviceName>Vivera Retainer</deviceName>
    <manufacturerName>Align Technology Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000000744</manufacturerSrn>
    <authorisedRepresentativeName>Align Technology B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000061</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010499</emdnCode>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>7883</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:01:02.755Z</lastUpdated>
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    <tradeName>00813110028099</tradeName>
    <deviceName>Dental Accessory</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010280</emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-160-002</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:49:58.595Z</lastUpdated>
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    <udiDi>00813110026910</udiDi>
    <basicUdiDi>B-00813110026910</basicUdiDi>
    <tradeName>00813110026910</tradeName>
    <deviceName>Dental Accessory</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010280</emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-160-003</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:49:02.519Z</lastUpdated>
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    <udiDi>00813110025234</udiDi>
    <basicUdiDi>B-00813110025234</basicUdiDi>
    <tradeName>00813110025234</tradeName>
    <deviceName>Dental Accessory</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010280</emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-250-571</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:48:55.448Z</lastUpdated>
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    <udiDi>00813110025227</udiDi>
    <basicUdiDi>B-00813110025227</basicUdiDi>
    <tradeName>00813110025227</tradeName>
    <deviceName>Dental Accessory</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010280</emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-250-471</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:48:50.955Z</lastUpdated>
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    <udiDi>00813110025210</udiDi>
    <basicUdiDi>B-00813110025210</basicUdiDi>
    <tradeName>00813110025210</tradeName>
    <deviceName>Dental Accessory</deviceName>
    <manufacturerName>Bicon, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000002782</manufacturerSrn>
    <authorisedRepresentativeName>Bicon Europe Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000002497</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Q010280</emdnCode>
    <emdnDescription>PROSTHETIC DENTISTRY DEVICES - ACCESSORIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>260-250-371</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:48:50.941Z</lastUpdated>
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    <udiDi>00810123481255</udiDi>
    <basicUdiDi>B-00810123481255</basicUdiDi>
    <tradeName>00810123481255</tradeName>
    <deviceName>27ga ACTU8 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>VS0744.27</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:05.924Z</lastUpdated>
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    <udiDi>00810123481248</udiDi>
    <basicUdiDi>B-00810123481248</basicUdiDi>
    <tradeName>00810123481248</tradeName>
    <deviceName>25ga 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>VS0744.25-35</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:03.504Z</lastUpdated>
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    <udiDi>00810123481231</udiDi>
    <basicUdiDi>B-00810123481231</basicUdiDi>
    <tradeName>00810123481231</tradeName>
    <deviceName>25ga ACTU8 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>VS0744.25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:40:01.917Z</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>2026-08-01T07:40:01.125Z</lastUpdated>
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    <udiDi>00810123481217</udiDi>
    <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>
    <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</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:39:59.513Z</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>
    <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>VS0743.25</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:39:57.112Z</lastUpdated>
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    <udiDi>00810123481194</udiDi>
    <basicUdiDi>B-00810123481194</basicUdiDi>
    <tradeName>00810123481194</tradeName>
    <deviceName>23ga ACTU8 End 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>VS0743.23</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:39:55.504Z</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>2026-08-01T07:39:54.724Z</lastUpdated>
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    <udiDi>00810123481170</udiDi>
    <basicUdiDi>B-00810123481170</basicUdiDi>
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    <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>2026-08-01T07:39:53.112Z</lastUpdated>
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    <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>
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    <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>2026-08-01T07:39:50.705Z</lastUpdated>
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    <deviceName>23ga ACTU8 Tewari (T2) 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>VS0742.23</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:39:49.131Z</lastUpdated>
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    <udiDi>00810123481132</udiDi>
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    <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>2026-08-01T07:39:48.320Z</lastUpdated>
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