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<eudamedExport entity="devices">
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    <udiDi>00818053022579</udiDi>
    <basicUdiDi>B-00818053022579</basicUdiDi>
    <tradeName>XCEL Detachment Controller</tradeName>
    <deviceName>XCEL Detachment Controller</deviceName>
    <manufacturerName>BALT USA LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008651</manufacturerSrn>
    <authorisedRepresentativeName>BALT EXTRUSION SAS</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>FR-AR-000042061</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12109099</emdnCode>
    <emdnDescription>VARIOUS NEUROLOGY AND NEUROSURGERY INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>XCEL</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:16:19.708Z</lastUpdated>
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    <udiDi>00817708023404</udiDi>
    <basicUdiDi>B-00817708023404</basicUdiDi>
    <tradeName>VersaPump Infuser</tradeName>
    <deviceName>VersaPump Infuser</deviceName>
    <manufacturerName>EMED Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000012148</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030301</emdnCode>
    <emdnDescription>INFUSION PUMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP-0010209</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:11:07.419Z</lastUpdated>
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    <udiDi>00817708021257</udiDi>
    <basicUdiDi>B-00817708021257</basicUdiDi>
    <tradeName>EMED Sub-Q Infusion Set</tradeName>
    <deviceName>Subcutaneous Infusion Set</deviceName>
    <manufacturerName>EMED Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000012148</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030385</emdnCode>
    <emdnDescription>INFUSION INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SUB-109-G24</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:11:05.814Z</lastUpdated>
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    <udiDi>00817708020274</udiDi>
    <basicUdiDi>B-00817708020274</basicUdiDi>
    <tradeName>SGI60 Infuser</tradeName>
    <deviceName>SGIg60 Infusion Pump</deviceName>
    <manufacturerName>EMED Technologies Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000012148</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030301</emdnCode>
    <emdnDescription>INFUSION PUMPS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FP-0010002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:11:01.017Z</lastUpdated>
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    <udiDi>00817495025049</udiDi>
    <basicUdiDi>B-00817495025049</basicUdiDi>
    <tradeName>GentleMax Pro Plus Large Spot ACC HP</tradeName>
    <deviceName>GentleMax Pro Plus Large Spot ACC HP</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>FIN101205</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:10:59.621Z</lastUpdated>
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  <row>
    <udiDi>00817495025032</udiDi>
    <basicUdiDi>B-00817495025032</basicUdiDi>
    <tradeName>GentleMax Pro Plus Medium DCD HP</tradeName>
    <deviceName>GentleMax Pro Plus Large Spot DCD HP</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>FIN101204</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:10:58.760Z</lastUpdated>
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    <udiDi>00817495025025</udiDi>
    <basicUdiDi>B-00817495025025</basicUdiDi>
    <tradeName>GentleCool Pro Plus™ DCD Cryogen</tradeName>
    <deviceName>GentleCool Pro Plus™ DCD Cryogen</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>Z12011006</emdnCode>
    <emdnDescription>DIODE–PUMPED SOLID–STATE (DPSS) SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIN101112</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:10:57.005Z</lastUpdated>
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  <row>
    <udiDi>00817495025001</udiDi>
    <basicUdiDi>B-00817495025001</basicUdiDi>
    <tradeName>GentleCool Pro Plus™ DCD Cryogen</tradeName>
    <deviceName>GentleCool Pro Plus™ DCD Cryogen</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>Z12011017</emdnCode>
    <emdnDescription>NEODYMIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIN101110</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:10:54.838Z</lastUpdated>
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    <udiDi>00817495024967</udiDi>
    <basicUdiDi>B-00817495024967</basicUdiDi>
    <tradeName>GentleCool Pro Plus™ DCD Cryogen</tradeName>
    <deviceName>GentleCool Pro Plus™ DCD Cryogen</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>Z12011006</emdnCode>
    <emdnDescription>DIODE–PUMPED SOLID–STATE (DPSS) SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIN101106</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:10:53.005Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817495024943</udiDi>
    <basicUdiDi>B-00817495024943</basicUdiDi>
    <tradeName>GentleCool Pro Plus™</tradeName>
    <deviceName>GentleCool Pro Plus™ DCD Cryogen</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>Z12011017</emdnCode>
    <emdnDescription>NEODYMIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIN101100</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:10:52.208Z</lastUpdated>
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  <row>
    <udiDi>00817495024905</udiDi>
    <basicUdiDi>B-00817495024905</basicUdiDi>
    <tradeName>GentleCool Pro Plus™</tradeName>
    <deviceName></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>Z12011006</emdnCode>
    <emdnDescription>DIODE–PUMPED SOLID–STATE (DPSS) SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIN101100</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:10:50.611Z</lastUpdated>
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  <row>
    <udiDi>00817495024882</udiDi>
    <basicUdiDi>B-00817495024882</basicUdiDi>
    <tradeName>GentleCool Pro Plus™</tradeName>
    <deviceName>GentleCool Pro Plus™ DCD Cryogen</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>Z12011006</emdnCode>
    <emdnDescription>DIODE–PUMPED SOLID–STATE (DPSS) SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FIN101098</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:10:48.195Z</lastUpdated>
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  <row>
    <udiDi>00817495024653</udiDi>
    <basicUdiDi>B-00817495024653</basicUdiDi>
    <tradeName>Gentle Max Pro</tradeName>
    <deviceName>GentleMax 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>Z12011017</emdnCode>
    <emdnDescription>NEODYMIUM SURGICAL LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9914-CH-9035</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:10:46.585Z</lastUpdated>
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    <udiDi>00817495024592</udiDi>
    <basicUdiDi>B-00817495024592</basicUdiDi>
    <tradeName>GentleMax Pro Medium DCD HP</tradeName>
    <deviceName>GentleMax Pro Medium DCD HP</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>FIN100985</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:10:45.789Z</lastUpdated>
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  <row>
    <udiDi>00817495024011</udiDi>
    <basicUdiDi>B-00817495024011</basicUdiDi>
    <tradeName>GentleMax Pro Plus Medium DCD HP</tradeName>
    <deviceName>GentleMax Pro Plus Medium DCD HP</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>FIN103337</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:10:30.554Z</lastUpdated>
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    <udiDi>00817495023960</udiDi>
    <basicUdiDi>B-00817495023960</basicUdiDi>
    <tradeName>Nordlys Mini</tradeName>
    <deviceName>Nordlys Mini</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>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9SYS7853</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:10:26.536Z</lastUpdated>
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    <udiDi>00817495023953</udiDi>
    <basicUdiDi>B-00817495023953</basicUdiDi>
    <tradeName>1550 applicator</tradeName>
    <deviceName>1550 Aplicator</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>Z12011019</emdnCode>
    <emdnDescription>MULTI–PLATFORM LASER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1550 applicator / 9APP7830</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:10:26.052Z</lastUpdated>
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    <udiDi>00817495023915</udiDi>
    <basicUdiDi>B-00817495023915</basicUdiDi>
    <tradeName>GentleMax Pro Plus Large Spot ACC HP</tradeName>
    <deviceName>GentleMax Pro Plus Large Spot ACC HP</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>FIN101959</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:10:24.925Z</lastUpdated>
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    <udiDi>00817495023854</udiDi>
    <basicUdiDi>B-00817495023854</basicUdiDi>
    <tradeName>GentleMax Pro Plus Large Spot DCD HP</tradeName>
    <deviceName>GentleMax Pro Plus Large Spot DCD HP</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>FIN101958</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:10:24.317Z</lastUpdated>
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    <udiDi>00817495023595</udiDi>
    <basicUdiDi>B-00817495023595</basicUdiDi>
    <tradeName>00817495023595</tradeName>
    <deviceName></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-JB-9060</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-08-01T08:10:19.336Z</lastUpdated>
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