<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00860000244312</udiDi>
    <basicUdiDi>B-00860000244312</basicUdiDi>
    <tradeName>00860000244312</tradeName>
    <deviceName>ActiGraft</deviceName>
    <manufacturerName>RedDress Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000010237</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12019003</emdnCode>
    <emdnDescription>WOUND TREATMENT EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RD2002P</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:44:46.812Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850054026477</udiDi>
    <basicUdiDi>B-00850054026477</basicUdiDi>
    <tradeName>AccuDiagTM Total Human IgE</tradeName>
    <deviceName>Total Human IgE ELISA Kit</deviceName>
    <manufacturerName>Diagnostic Automation/ Cortez Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051963</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020201</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - TOTAL</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1801-18</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:03:21.722Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850049545655</udiDi>
    <basicUdiDi>B-00850049545655</basicUdiDi>
    <tradeName>AccuDiag™ Human Specific IgE  (20 Perennial Allergens)</tradeName>
    <deviceName>AccuDiag™ Human Specific IgE  (20 Perennial Allergens)</deviceName>
    <manufacturerName>Diagnostic Automation/ Cortez Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051963</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020202</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5253-8</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:03:14.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850049545648</udiDi>
    <basicUdiDi>B-00850049545648</basicUdiDi>
    <tradeName>AccuDiag™ Human Specific IgE (20 Atopic Allergens)</tradeName>
    <deviceName>AccuDiag™ Human Specific IgE (20 Atopic Allergens)</deviceName>
    <manufacturerName>Diagnostic Automation/ Cortez Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051963</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020202</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5151-8</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:03:10.523Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850049545204</udiDi>
    <basicUdiDi>B-00850049545204</basicUdiDi>
    <tradeName>AccuDiag™ Human Specific IgE  (20 Food Allergens)</tradeName>
    <deviceName>AccuDiag™ Human Specific IgE  (20 Food Allergens)</deviceName>
    <manufacturerName>Diagnostic Automation/ Cortez Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051963</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01020202</emdnCode>
    <emdnDescription>IMMUNOGLOBULIN E - SPECIFIC, MONOTEST/MONORESULT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5152-8</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:03:09.716Z</lastUpdated>
  </row>
  <row>
    <udiDi>00850049545006</udiDi>
    <basicUdiDi>B-00850049545006</basicUdiDi>
    <tradeName>AccuDiag™ Folate  ELISA</tradeName>
    <deviceName>AccuDiag™ Folate  ELISA</deviceName>
    <manufacturerName>Diagnostic Automation/ Cortez Diagnostics, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000051963</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0102070103</emdnCode>
    <emdnDescription>FOLATE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3127-15</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:03:08.920Z</lastUpdated>
  </row>
  <row>
    <udiDi>++M661Epidural3QX</udiDi>
    <basicUdiDi>B-++M661Epidural3QX</basicUdiDi>
    <tradeName>Spectra Epidural Needle</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spectra Medical Devices, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008491</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>EPIDURAL ANAESTHESIA NEEDLES AND KITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S88518-3.501S</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T21:21:30.027Z</lastUpdated>
  </row>
  <row>
    <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>2026-07-04T19:13:01.159Z</lastUpdated>
  </row>
  <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>2026-07-04T19:12:58.732Z</lastUpdated>
  </row>
  <row>
    <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>2026-07-04T19:12:57.133Z</lastUpdated>
  </row>
  <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>2026-07-04T19:12:56.323Z</lastUpdated>
  </row>
  <row>
    <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>2026-07-04T19:12:54.727Z</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>2026-07-04T19:12:52.329Z</lastUpdated>
  </row>
  <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>2026-07-04T19:12:50.730Z</lastUpdated>
  </row>
  <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>2026-07-04T19:12:49.927Z</lastUpdated>
  </row>
  <row>
    <udiDi>00817495024677</udiDi>
    <basicUdiDi>B-00817495024677</basicUdiDi>
    <tradeName>00817495024677</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>L2499</emdnCode>
    <emdnDescription>DERMATOLOGICAL SURGERY INSTRUMENTS, REUSABLE - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9914-CH-9060</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-04T19:12:48.323Z</lastUpdated>
  </row>
  <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>2026-07-04T19:12:45.927Z</lastUpdated>
  </row>
  <row>
    <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>2026-07-04T19:12:44.326Z</lastUpdated>
  </row>
  <row>
    <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>2026-07-04T19:12:43.526Z</lastUpdated>
  </row>
  <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>2026-07-04T19:12:41.915Z</lastUpdated>
  </row>
</eudamedExport>