<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <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>
  </row>
  <row>
    <udiDi>00811331010688</udiDi>
    <basicUdiDi>B-00811331010688</basicUdiDi>
    <tradeName>TZ DEFIBRILLATOR ELECTRODES</tradeName>
    <deviceName>TZ DEFIBRILLATOR ELECTRODES</deviceName>
    <manufacturerName>TZ Medical inc</manufacturerName>
    <manufacturerSrn>US-MF-000027311</manufacturerSrn>
    <authorisedRepresentativeName>CEpartner4U</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000111</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030585</emdnCode>
    <emdnDescription>DEFIBRILLATORS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P-311-T1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:41:44.707Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959490222</udiDi>
    <basicUdiDi>B-00606959490222</basicUdiDi>
    <tradeName>DreamStation CPAP w/AHI/Cell ES</tradeName>
    <deviceName>DreamStation CPAP w/AHI/Cell ES</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESX201S15C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:01:31.504Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959490215</udiDi>
    <basicUdiDi>B-00606959490215</basicUdiDi>
    <tradeName>DreamStation CPAP w/AHI ES</tradeName>
    <deviceName>DreamStation CPAP w/AHI ES</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESX201S15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:01:27.499Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959490192</udiDi>
    <basicUdiDi>B-00606959490192</basicUdiDi>
    <tradeName>DreamStation Auto CPAP w/Cell ES</tradeName>
    <deviceName>DreamStation Auto CPAP w/Cell ES</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESX500S15C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:01:26.702Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959490185</udiDi>
    <basicUdiDi>B-00606959490185</basicUdiDi>
    <tradeName>DreamStation CPAP Pro with Humidifier/Cell ES</tradeName>
    <deviceName>DreamStation CPAP Pro with Humidifier/Cell ES</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ESX401H15C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:01:25.898Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959428591</udiDi>
    <basicUdiDi>B-00606959428591</basicUdiDi>
    <tradeName>DreamStation Auto CPAP w/Humidifier, w/Cell, Praxair, PT</tradeName>
    <deviceName>DreamStation Auto CPAP w/Humidifier, w/Cell, Praxair, PT</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PTX500H15PRC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:01:25.096Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959428522</udiDi>
    <basicUdiDi>B-00606959428522</basicUdiDi>
    <tradeName>DreamStation Auto BiPAP, FR</tradeName>
    <deviceName>DreamStation Auto BiPAP, FR</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>FRX700S14</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:01:21.099Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959428393</udiDi>
    <basicUdiDi>B-00606959428393</basicUdiDi>
    <tradeName>DREAMSTATION AUTO BIPAP W/HUMID Cell LA</tradeName>
    <deviceName>DREAMSTATION AUTO BIPAP W/HUMID Cell LA</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAX700H15C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:01:20.294Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959428379</udiDi>
    <basicUdiDi>B-00606959428379</basicUdiDi>
    <tradeName>DREAMSTATION AUTO CPAP W/HUMIDCell, LA</tradeName>
    <deviceName>DREAMSTATION AUTO CPAP W/HUMIDCell, LA</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAX500H15C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:01:19.491Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959428362</udiDi>
    <basicUdiDi>B-00606959428362</basicUdiDi>
    <tradeName>DREAMSTATION CPAP PRO W/HUMID Cell LA</tradeName>
    <deviceName>DREAMSTATION CPAP PRO W/HUMID Cell LA</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAX400H15C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:01:18.694Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959428355</udiDi>
    <basicUdiDi>B-00606959428355</basicUdiDi>
    <tradeName>DREAMSTATION CPAP W/HUMID,LA,Cell Modem,</tradeName>
    <deviceName>DREAMSTATION CPAP W/HUMID,LA,Cell Modem,</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAX200H15C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:01:14.918Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959428300</udiDi>
    <basicUdiDi>B-00606959428300</basicUdiDi>
    <tradeName>DreamStation BiPAP Pro w/Humid w/H Tube, Latin America</tradeName>
    <deviceName>DreamStation BiPAP Pro w/Humid w/H Tube, Latin America</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAX600T15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:01:13.889Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959428218</udiDi>
    <basicUdiDi>B-00606959428218</basicUdiDi>
    <tradeName>DreamStation CPAP with Humidifier, Latin America</tradeName>
    <deviceName>DreamStation CPAP with Humidifier, Latin America</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LAX200H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:01:13.051Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959428201</udiDi>
    <basicUdiDi>B-00606959428201</basicUdiDi>
    <tradeName>DREAMSTATIONAUTO BIPAP, AR+ Cell Modem,</tradeName>
    <deviceName>DREAMSTATIONAUTO BIPAP, AR+ Cell Modem,</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARX700S15C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:01:13.021Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959428188</udiDi>
    <basicUdiDi>B-00606959428188</basicUdiDi>
    <tradeName>DREAMSTATION AUTO CPAP W/HUMIDIFIER Cell</tradeName>
    <deviceName>DREAMSTATION AUTO CPAP W/HUMIDIFIER Cell</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARX500H15C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:01:09.922Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959428126</udiDi>
    <basicUdiDi>B-00606959428126</basicUdiDi>
    <tradeName>DreamStation BiPAP Pro with Humidifier, AR</tradeName>
    <deviceName>DreamStation BiPAP Pro with Humidifier, AR</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARX600H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:01:08.108Z</lastUpdated>
  </row>
  <row>
    <udiDi>00606959428102</udiDi>
    <basicUdiDi>B-00606959428102</basicUdiDi>
    <tradeName>DreamStation Auto CPAP with Humidifier, AR</tradeName>
    <deviceName>DreamStation Auto CPAP with Humidifier, AR</deviceName>
    <manufacturerName>Respironics Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002301</manufacturerSrn>
    <authorisedRepresentativeName>Respironics Deutschland GmbH &amp; Co.KG</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006164</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>Z12030102</emdnCode>
    <emdnDescription>CONTINUOUS POSITIVE PRESSURE EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ARX500H15</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-08-01T07:01:05.949Z</lastUpdated>
  </row>
</eudamedExport>