<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>+G462MAS0025700023</udiDi>
    <basicUdiDi>++G462MAS0257PM</basicUdiDi>
    <tradeName>OXIGENOTERAPIA NORTE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Oxigenoterapia Norte SACIFIA</manufacturerName>
    <manufacturerSrn>AR-MF-000034989</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>MAS-00257-00023</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:42:01.809Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290001424001</udiDi>
    <basicUdiDi>B-07290001424001</basicUdiDi>
    <tradeName>Temple Touch Pro (TTP)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Medisim Ltd</manufacturerName>
    <manufacturerSrn>IL-MF-000034512</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TTP-3AKIT</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:33:49.937Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800079500089</udiDi>
    <basicUdiDi>880007950008CX</basicUdiDi>
    <tradeName>Healerbot</tradeName>
    <deviceName>Healerbot_HM</deviceName>
    <manufacturerName>P&amp;S Robotics Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022157</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120616</emdnCode>
    <emdnDescription>ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:28:46.326Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800079500072</udiDi>
    <basicUdiDi>880007950007CV</basicUdiDi>
    <tradeName>Healerbot</tradeName>
    <deviceName>Healerbot_HA</deviceName>
    <manufacturerName>P&amp;S Robotics Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022157</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120616</emdnCode>
    <emdnDescription>ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:28:45.520Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800079500065</udiDi>
    <basicUdiDi>880007950006CT</basicUdiDi>
    <tradeName>Healerbot</tradeName>
    <deviceName>Healerbot_H</deviceName>
    <manufacturerName>P&amp;S Robotics Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022157</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120616</emdnCode>
    <emdnDescription>ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:28:43.928Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800079500041</udiDi>
    <basicUdiDi>880007950004CP</basicUdiDi>
    <tradeName>Walkbot</tradeName>
    <deviceName>Walkbot_P</deviceName>
    <manufacturerName>P&amp;S Robotics Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022157</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120616</emdnCode>
    <emdnDescription>ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:28:41.630Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800079500034</udiDi>
    <basicUdiDi>880007950003CM</basicUdiDi>
    <tradeName>Walkbot</tradeName>
    <deviceName>Walkbot_G</deviceName>
    <manufacturerName>P&amp;S Robotics Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022157</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120616</emdnCode>
    <emdnDescription>ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:28:39.137Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800079500027</udiDi>
    <basicUdiDi>880007950002CK</basicUdiDi>
    <tradeName>Walkbot</tradeName>
    <deviceName>Walkbot_K</deviceName>
    <manufacturerName>P&amp;S Robotics Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022157</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120616</emdnCode>
    <emdnDescription>ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:28:38.319Z</lastUpdated>
  </row>
  <row>
    <udiDi>08800079500010</udiDi>
    <basicUdiDi>880007950001CH</basicUdiDi>
    <tradeName>Walkbot</tradeName>
    <deviceName>Walkbot_S</deviceName>
    <manufacturerName>P&amp;S Robotics Co.,Ltd.</manufacturerName>
    <manufacturerSrn>KR-MF-000022157</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z120616</emdnCode>
    <emdnDescription>ELECTROMECHANICAL SYSTEMS FOR PHYSICAL THERAPY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>0</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T17:28:36.720Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540263000032</udiDi>
    <basicUdiDi>7540263VMS+4YF</basicUdiDi>
    <tradeName>Ventripoint Medical System Plus</tradeName>
    <deviceName>Ventripoint Medical System Plus</deviceName>
    <manufacturerName>Ventripoint Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>CA-MF-000030095</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040192</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K241222</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:26:48.924Z</lastUpdated>
  </row>
  <row>
    <udiDi>07540263000025</udiDi>
    <basicUdiDi>7540263VMS+3YD</basicUdiDi>
    <tradeName>Ventripoint Medical System Plus (VMS+)</tradeName>
    <deviceName>Ventripoint Medical System Plus</deviceName>
    <manufacturerName>Ventripoint Diagnostics Ltd.</manufacturerName>
    <manufacturerSrn>CA-MF-000030095</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z11040192</emdnCode>
    <emdnDescription>ULTRASOUND SCANNERS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>K191493</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:26:44.932Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290109225005</udiDi>
    <basicUdiDi>729010922AC16000ME</basicUdiDi>
    <tradeName>EndoPAT™ PneumaticPAT™ probe</tradeName>
    <deviceName>Pneumatic Endo probe</deviceName>
    <manufacturerName>Itamar Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000012046</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12030285</emdnCode>
    <emdnDescription>VITAL SIGNS MONITORING INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC1600005</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:29:35.683Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290109223568</udiDi>
    <basicUdiDi>729010922AC21109MD</basicUdiDi>
    <tradeName>WatchPAT™400</tradeName>
    <deviceName>WatchPAT400</deviceName>
    <manufacturerName>Itamar Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000012046</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03010299</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AS2110900</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:29:34.906Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290109222837</udiDi>
    <basicUdiDi>729010922AC20003LM</basicUdiDi>
    <tradeName>WatchPAT™ Tamper Proof Bracelet</tradeName>
    <deviceName>Tamper-Proof Bracelet for WatchPAT</deviceName>
    <manufacturerName>Itamar Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000012046</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03010299</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC2000300</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:29:34.086Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290109222424</udiDi>
    <basicUdiDi>729010922AC21508MX</basicUdiDi>
    <tradeName>WatchPAT™ONE</tradeName>
    <deviceName>WatchPAT ONE</deviceName>
    <manufacturerName>Itamar Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000012046</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03010299</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC2110800</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:29:33.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290109222134</udiDi>
    <basicUdiDi>729010922AC20001LH</basicUdiDi>
    <tradeName>07290109222134</tradeName>
    <deviceName>Adhesive Foam for SBP/RESBP</deviceName>
    <manufacturerName>Itamar Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000012046</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03010299</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC2000112</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:29:29.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290109222035</udiDi>
    <basicUdiDi>729010922AC21107M9</basicUdiDi>
    <tradeName>WatchPAT™ Central Plus Sensor</tradeName>
    <deviceName>Watch-PAT300</deviceName>
    <manufacturerName>Itamar Medical Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000012046</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Q03010299</emdnCode>
    <emdnDescription>ANTISNORING AND OBSTRUCTIVE SLEEP APNOEA DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AC3000100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:29:28.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290018945995</udiDi>
    <basicUdiDi>7290018945AFISCOOTERSECQ</basicUdiDi>
    <tradeName>FT00236</tradeName>
    <deviceName>AFISCOOTER SE</deviceName>
    <manufacturerName>Afikim Electric Vehicles</manufacturerName>
    <manufacturerSrn>IL-MF-000018381</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y122124</emdnCode>
    <emdnDescription>ELECTRIC SCOOTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFISCOOTER SE</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:23:21.529Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290018945216</udiDi>
    <basicUdiDi>7290018945AFISCOOTERS8D</basicUdiDi>
    <tradeName>FTS4500</tradeName>
    <deviceName>AFISCOOTER S</deviceName>
    <manufacturerName>Afikim Electric Vehicles</manufacturerName>
    <manufacturerSrn>IL-MF-000018381</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y122124</emdnCode>
    <emdnDescription>ELECTRIC SCOOTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFISCOOTER S4 HD</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:23:16.723Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290018945209</udiDi>
    <basicUdiDi>7290018945AFISCOOTERC7D</basicUdiDi>
    <tradeName>FTC3500</tradeName>
    <deviceName>AFISCOOTER C</deviceName>
    <manufacturerName>Afikim Electric Vehicles</manufacturerName>
    <manufacturerSrn>IL-MF-000018381</manufacturerSrn>
    <authorisedRepresentativeName>Arazy Group GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000007685</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Y122124</emdnCode>
    <emdnDescription>ELECTRIC SCOOTERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFISCOOTER C3</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:23:15.940Z</lastUpdated>
  </row>
</eudamedExport>