<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-8057502900132ZB</udiDi>
    <basicUdiDi>B-8057502900132ZB</basicUdiDi>
    <tradeName>GVP MED</tradeName>
    <deviceName>HEATING MATTRESS</deviceName>
    <manufacturerName>GVP MED SAS DI MIAN ANTONELLA &amp; C</manufacturerName>
    <manufacturerSrn>IT-MF-000007605</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040208</emdnCode>
    <emdnDescription>BODY THERMOREGULATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCLMED4.0</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:48:46.365Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8057502900033Z8</udiDi>
    <basicUdiDi>B-8057502900033Z8</basicUdiDi>
    <tradeName>GVP MED</tradeName>
    <deviceName>HEATING MATTRESS</deviceName>
    <manufacturerName>GVP MED SAS DI MIAN ANTONELLA &amp; C</manufacturerName>
    <manufacturerSrn>IT-MF-000007605</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040208</emdnCode>
    <emdnDescription>BODY THERMOREGULATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRMMEDP/SS 2.0</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:48:31.154Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8057502900026ZB</udiDi>
    <basicUdiDi>B-8057502900026ZB</basicUdiDi>
    <tradeName>GVP MED</tradeName>
    <deviceName>HEATING MATTRESS</deviceName>
    <manufacturerName>GVP MED SAS DI MIAN ANTONELLA &amp; C</manufacturerName>
    <manufacturerSrn>IT-MF-000007605</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040208</emdnCode>
    <emdnDescription>BODY THERMOREGULATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRMMEDP/S 2.0</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:48:29.556Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8057502900019ZE</udiDi>
    <basicUdiDi>B-8057502900019ZE</basicUdiDi>
    <tradeName>GVP MED</tradeName>
    <deviceName>HEATING MATTRESS</deviceName>
    <manufacturerName>GVP MED SAS DI MIAN ANTONELLA &amp; C</manufacturerName>
    <manufacturerSrn>IT-MF-000007605</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040208</emdnCode>
    <emdnDescription>BODY THERMOREGULATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TRMMEDP2.0</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:48:27.148Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8057502900002YV</udiDi>
    <basicUdiDi>B-8057502900002YV</basicUdiDi>
    <tradeName>GVP MED</tradeName>
    <deviceName>HEATING MATTRESS</deviceName>
    <manufacturerName>GVP MED SAS DI MIAN ANTONELLA &amp; C</manufacturerName>
    <manufacturerSrn>IT-MF-000007605</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040208</emdnCode>
    <emdnDescription>BODY THERMOREGULATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SCLMED2.0</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:48:25.569Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-764020721NC200XX</udiDi>
    <basicUdiDi>B-764020721NC200XX</basicUdiDi>
    <tradeName>Mesh nebulizer</tradeName>
    <deviceName>Mesh nebulizer</deviceName>
    <manufacturerName>Rossmax Swiss GmbH</manufacturerName>
    <manufacturerSrn>CH-MF-000011245</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040210</emdnCode>
    <emdnDescription>ULTRASONIC NEBULISERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NC200</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:13:14.104Z</lastUpdated>
  </row>
  <row>
    <udiDi>17290016586272</udiDi>
    <basicUdiDi>B-17290016586272</basicUdiDi>
    <tradeName>17290016586272</tradeName>
    <deviceName>gen36L</deviceName>
    <manufacturerName>Pollogen Ltd</manufacturerName>
    <manufacturerSrn>IL-MF-000031034</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040285</emdnCode>
    <emdnDescription>GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30010160,30010160LP,30010160BK</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:13:17.744Z</lastUpdated>
  </row>
  <row>
    <udiDi>17290016586265</udiDi>
    <basicUdiDi>B-17290016586265</basicUdiDi>
    <tradeName>17290016586265</tradeName>
    <deviceName>gen100</deviceName>
    <manufacturerName>Pollogen Ltd</manufacturerName>
    <manufacturerSrn>IL-MF-000031034</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040285</emdnCode>
    <emdnDescription>GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30010150,30010150LP,30010150BK</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:13:16.486Z</lastUpdated>
  </row>
  <row>
    <udiDi>17290016586128</udiDi>
    <basicUdiDi>B-17290016586128</basicUdiDi>
    <tradeName>17290016586128</tradeName>
    <deviceName>H7X7</deviceName>
    <manufacturerName>Pollogen Ltd</manufacturerName>
    <manufacturerSrn>IL-MF-000031034</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040285</emdnCode>
    <emdnDescription>GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30010140,30010140LP,30010140BK</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:13:12.477Z</lastUpdated>
  </row>
  <row>
    <udiDi>17290016586067</udiDi>
    <basicUdiDi>B-17290016586067</basicUdiDi>
    <tradeName>17290016586067</tradeName>
    <deviceName>gen 12</deviceName>
    <manufacturerName>Pollogen Ltd</manufacturerName>
    <manufacturerSrn>IL-MF-000031034</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040285</emdnCode>
    <emdnDescription>GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30010080,30010080LP,30010080BK</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:13:11.680Z</lastUpdated>
  </row>
  <row>
    <udiDi>17290016586050</udiDi>
    <basicUdiDi>B-17290016586050</basicUdiDi>
    <tradeName>17290016586050</tradeName>
    <deviceName>gen36</deviceName>
    <manufacturerName>Pollogen Ltd</manufacturerName>
    <manufacturerSrn>IL-MF-000031034</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040285</emdnCode>
    <emdnDescription>GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>30010090, 30010090LP,30010090BK</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-11T07:13:10.883Z</lastUpdated>
  </row>
  <row>
    <udiDi>1311682TFMEDSCORES4.283</udiDi>
    <basicUdiDi>B-1311682TFMEDSCORES4.283</basicUdiDi>
    <tradeName>1311682TFMEDSCORES4.283</tradeName>
    <deviceName>THERAFOX PRO GHG Praxisdienst Medizinische Scores</deviceName>
    <manufacturerName>ifap Service-Institut für Ärzte und Apotheker GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006908</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040292</emdnCode>
    <emdnDescription>GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>v4.2.0</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:49:55.894Z</lastUpdated>
  </row>
  <row>
    <udiDi>1311682TFMEDSCORES4.161</udiDi>
    <basicUdiDi>B-1311682TFMEDSCORES4.161</basicUdiDi>
    <tradeName>GHG Praxisdienst Medizinische Scores</tradeName>
    <deviceName>THERAFOX PRO GHG Praxisdienst Medizinische Scores</deviceName>
    <manufacturerName>ifap Service-Institut für Ärzte und Apotheker GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006908</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040292</emdnCode>
    <emdnDescription>GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ab R4.1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:49:51.879Z</lastUpdated>
  </row>
  <row>
    <udiDi>1311682TFMEDSCORES3.645</udiDi>
    <basicUdiDi>B-1311682TFMEDSCORES3.645</basicUdiDi>
    <tradeName>GHG Praxisdienst Medizinische Scores</tradeName>
    <deviceName>THERAFOX PRO GHG Praxisdienst Medizinische Scores</deviceName>
    <manufacturerName>ifap Service-Institut für Ärzte und Apotheker GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000006908</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12040292</emdnCode>
    <emdnDescription>GENERAL MEDICINE THERAPEUTIC TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE</emdnDescription>
    <deviceStatus>Artık piyasada değil</deviceStatus>
    <reference>3.6</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-11T02:49:51.097Z</lastUpdated>
  </row>
  <row>
    <udiDi>10385081120289</udiDi>
    <basicUdiDi>B-10385081120289</basicUdiDi>
    <tradeName>Ferring Drug Delivery System</tradeName>
    <deviceName>DDM Ferring Drug Delivery System</deviceName>
    <manufacturerName>Insulet Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000007948</manufacturerSrn>
    <authorisedRepresentativeName>Insulet Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002337</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z1204021699</emdnCode>
    <emdnDescription>PORTABLE MICROINFUSION INSTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ZXG630</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:20:21.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>10385081120203</udiDi>
    <basicUdiDi>B-10385081120203</basicUdiDi>
    <tradeName>Omnipod Insulin Management System</tradeName>
    <deviceName>PDM-FIT450</deviceName>
    <manufacturerName>Insulet Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000007948</manufacturerSrn>
    <authorisedRepresentativeName>Insulet Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002337</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120402160101</emdnCode>
    <emdnDescription>PORTABLE INSULIN MICROINFUSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18900-9H</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:20:21.103Z</lastUpdated>
  </row>
  <row>
    <udiDi>10385081120197</udiDi>
    <basicUdiDi>B-10385081120197</basicUdiDi>
    <tradeName>Omnipod Insulin Management System</tradeName>
    <deviceName>Omnipod Insulin Management System</deviceName>
    <manufacturerName>Insulet Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000007948</manufacturerSrn>
    <authorisedRepresentativeName>Insulet Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002337</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120402160101</emdnCode>
    <emdnDescription>PORTABLE INSULIN MICROINFUSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18900-6L</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:20:20.291Z</lastUpdated>
  </row>
  <row>
    <udiDi>10385081120180</udiDi>
    <basicUdiDi>B-10385081120180</basicUdiDi>
    <tradeName>Omnipod Insulin Management System</tradeName>
    <deviceName>Omnipod Insulin Management System</deviceName>
    <manufacturerName>Insulet Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000007948</manufacturerSrn>
    <authorisedRepresentativeName>Insulet Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002337</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120402160101</emdnCode>
    <emdnDescription>PORTABLE INSULIN MICROINFUSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18900-6G</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:20:16.280Z</lastUpdated>
  </row>
  <row>
    <udiDi>10385081120173</udiDi>
    <basicUdiDi>B-10385081120173</basicUdiDi>
    <tradeName>Omnipod Insulin Management System</tradeName>
    <deviceName>Omnipod Insulin Management System</deviceName>
    <manufacturerName>Insulet Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000007948</manufacturerSrn>
    <authorisedRepresentativeName>Insulet Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002337</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120402160101</emdnCode>
    <emdnDescription>PORTABLE INSULIN MICROINFUSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18900-6F</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:20:15.522Z</lastUpdated>
  </row>
  <row>
    <udiDi>10385081120166</udiDi>
    <basicUdiDi>B-10385081120166</basicUdiDi>
    <tradeName>Omnipod Insulin Management System</tradeName>
    <deviceName>PDM-DAT450</deviceName>
    <manufacturerName>Insulet Corporation</manufacturerName>
    <manufacturerSrn>US-MF-000007948</manufacturerSrn>
    <authorisedRepresentativeName>Insulet Netherlands B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002337</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z120402160101</emdnCode>
    <emdnDescription>PORTABLE INSULIN MICROINFUSORS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>18900-5T</reference>
    <placedOnMarketCountry>Denmark</placedOnMarketCountry>
    <lastUpdated>2026-07-10T23:20:14.684Z</lastUpdated>
  </row>
</eudamedExport>