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<eudamedExport entity="devices">
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    <basicUdiDi>B-00817495020082</basicUdiDi>
    <tradeName>GentleLASE Pro-U</tradeName>
    <deviceName>GentleLASE Pro-U</deviceName>
    <manufacturerName>Candela Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000022750</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011017</emdnCode>
    <emdnDescription>NEODYMIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9914-00-9035</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:08:11.147Z</lastUpdated>
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    <udiDi>00817495020044</udiDi>
    <basicUdiDi>B-00817495020044</basicUdiDi>
    <tradeName>GentleYAG Pro-U</tradeName>
    <deviceName>GentleYAG Pro-U</deviceName>
    <manufacturerName>Candela Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000022750</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011006</emdnCode>
    <emdnDescription>DIODE–PUMPED SOLID–STATE (DPSS) SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9914-00-9020</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:08:09.535Z</lastUpdated>
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    <udiDi>00817495020037</udiDi>
    <basicUdiDi>B-00817495020037</basicUdiDi>
    <tradeName>PicoWay Laser System</tradeName>
    <deviceName>PicoWay</deviceName>
    <manufacturerName>Candela Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000022750</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011006</emdnCode>
    <emdnDescription>DIODE–PUMPED SOLID–STATE (DPSS) SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9914-00- 9060</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:08:07.169Z</lastUpdated>
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    <udiDi>00817495020020</udiDi>
    <basicUdiDi>B-00817495020020</basicUdiDi>
    <tradeName>Vbeam Perfecta</tradeName>
    <deviceName>Vbeam Perfecta</deviceName>
    <manufacturerName>Candela Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000022750</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011012</emdnCode>
    <emdnDescription>DYE/ALEXANDRITE SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9914-08-0300</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:08:05.544Z</lastUpdated>
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  <row>
    <udiDi>00817495020013</udiDi>
    <basicUdiDi>B-00817495020013</basicUdiDi>
    <tradeName>Gentle Max Pro</tradeName>
    <deviceName>Gentle Max Pro</deviceName>
    <manufacturerName>Candela Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000022750</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011012</emdnCode>
    <emdnDescription>DYE/ALEXANDRITE SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9914-00-9035</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:08:04.743Z</lastUpdated>
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  <row>
    <udiDi>00817421021794</udiDi>
    <basicUdiDi>B-00817421021794</basicUdiDi>
    <tradeName>X-Guide</tradeName>
    <deviceName>X-Guide Surgical Navigation System</deviceName>
    <manufacturerName>X-Nav Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011401</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION SYSTEM</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P011000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:06:09.420Z</lastUpdated>
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  <row>
    <udiDi>00817421021442</udiDi>
    <basicUdiDi>B-00817421021442</basicUdiDi>
    <tradeName>00817421021442</tradeName>
    <deviceName></deviceName>
    <manufacturerName>X-Nav Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011485</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P010925</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:04:08.104Z</lastUpdated>
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  <row>
    <udiDi>00817421021428</udiDi>
    <basicUdiDi>B-00817421021428</basicUdiDi>
    <tradeName>00817421021428</tradeName>
    <deviceName></deviceName>
    <manufacturerName>X-Nav Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12011485</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P010924</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:04:07.291Z</lastUpdated>
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  <row>
    <udiDi>00817421021404</udiDi>
    <basicUdiDi>B-00817421021404</basicUdiDi>
    <tradeName>00817421021404</tradeName>
    <deviceName>BONE SCREW, EDX - 3.2Ø x 4mm - 2 ct.</deviceName>
    <manufacturerName>X-Nav Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011485</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P010923</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:04:06.949Z</lastUpdated>
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  <row>
    <udiDi>00817421021381</udiDi>
    <basicUdiDi>B-00817421021381</basicUdiDi>
    <tradeName>00817421021381</tradeName>
    <deviceName>BONE SCREW, EDX - 2.7Ø x 16mm - 2 ct.</deviceName>
    <manufacturerName>X-Nav Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011485</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P010922</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:04:05.687Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817421021367</udiDi>
    <basicUdiDi>B-00817421021367</basicUdiDi>
    <tradeName>00817421021367</tradeName>
    <deviceName>BONE SCREW, EDX - 2.7Ø x 8mm - 2 ct.</deviceName>
    <manufacturerName>X-Nav Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011485</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P010921</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:04:05.339Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817421021343</udiDi>
    <basicUdiDi>B-00817421021343</basicUdiDi>
    <tradeName>00817421021343</tradeName>
    <deviceName>BONE SCREW, EDX - 2.7Ø x 4mm - 2 ct.</deviceName>
    <manufacturerName>X-Nav Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011485</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P010920</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:04:04.463Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817421020469</udiDi>
    <basicUdiDi>B-00817421020469</basicUdiDi>
    <tradeName>X-Guide</tradeName>
    <deviceName>BONE SCREW - 2.7 x 10 mm - 3 ct.</deviceName>
    <manufacturerName>X-Nav Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011485</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P008843</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:04:00.080Z</lastUpdated>
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  <row>
    <udiDi>00817421020445</udiDi>
    <basicUdiDi>B-00817421020445</basicUdiDi>
    <tradeName>00817421020445</tradeName>
    <deviceName>BONE SCREW - 2.7Ø x 8mm - 3 ct.</deviceName>
    <manufacturerName>X-Nav Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011485</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P008842</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:03:59.267Z</lastUpdated>
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    <udiDi>00817421020421</udiDi>
    <basicUdiDi>B-00817421020421</basicUdiDi>
    <tradeName>00817421020421</tradeName>
    <deviceName>BONE SCREW - 2.7Ø x 6mm - 3 ct.</deviceName>
    <manufacturerName>X-Nav Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011485</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P008841</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:03:58.464Z</lastUpdated>
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    <udiDi>00817421020407</udiDi>
    <basicUdiDi>B-00817421020407</basicUdiDi>
    <tradeName>00817421020407</tradeName>
    <deviceName>BONE SCREW - 2.7Ø x 4mm - 3 ct.</deviceName>
    <manufacturerName>X-Nav Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011485</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P008840</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:03:57.667Z</lastUpdated>
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    <udiDi>00817421020384</udiDi>
    <basicUdiDi>B-00817421020384</basicUdiDi>
    <tradeName>X-Guide</tradeName>
    <deviceName>BONE SCREW - 2.0 x 10mm - 3 ct.</deviceName>
    <manufacturerName>X-Nav Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011485</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P008838</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:03:53.682Z</lastUpdated>
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    <udiDi>00817421020360</udiDi>
    <basicUdiDi>B-00817421020360</basicUdiDi>
    <tradeName>00817421020360</tradeName>
    <deviceName>BONE SCREW - 2.0Ø x 8mm - 3 ct.</deviceName>
    <manufacturerName>X-Nav Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011485</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P008837</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:03:52.872Z</lastUpdated>
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    <udiDi>00817421020346</udiDi>
    <basicUdiDi>B-00817421020346</basicUdiDi>
    <tradeName>00817421020346</tradeName>
    <deviceName>BONE SCREW - 2.0Ø x 6mm - 3 ct.</deviceName>
    <manufacturerName>X-Nav Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011485</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P008836</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:03:52.075Z</lastUpdated>
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    <udiDi>00817421020322</udiDi>
    <basicUdiDi>B-00817421020322</basicUdiDi>
    <tradeName>00817421020322</tradeName>
    <deviceName>BONE SCREW - 2.0Ø x 4mm - 3 ct.</deviceName>
    <manufacturerName>X-Nav Technologies, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000003234</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12011485</emdnCode>
    <emdnDescription>SURGICAL NAVIGATION INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P008835</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:03:51.281Z</lastUpdated>
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