<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>05404013003617</udiDi>
    <basicUdiDi>5404013000000000000026B</basicUdiDi>
    <tradeName>Hybernite RT 3100 (Single Limb)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERMOREGULATED BREATHING CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HFN12025BT1PRWGK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:38:31.809Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404013003624</udiDi>
    <basicUdiDi>5404013000000000000026B</basicUdiDi>
    <tradeName>Hybernite RT 2100 (Single Limb)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERMOREGULATED BREATHING CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HFN15023BT1SSWGK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:38:31.790Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404013003631</udiDi>
    <basicUdiDi>5404013000000000000026B</basicUdiDi>
    <tradeName>Hybernite RT 1100 (Single Limb)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERMOREGULATED BREATHING CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HFN19022BT1SSWGK</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:38:31.768Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404013003655</udiDi>
    <basicUdiDi>54040130000000000000067</basicUdiDi>
    <tradeName>Classic RT 12 White 10F&amp;15M/10F&amp;15M 1.20m</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HVN12012WT0PPWBC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:38:31.752Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404013003662</udiDi>
    <basicUdiDi>54040130000000000000067</basicUdiDi>
    <tradeName>Classic RT 12 White 22F/10F&amp;15M 0.60m</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HVN12D60WT0SPWBB</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:38:31.736Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404013003679</udiDi>
    <basicUdiDi>5404013000000000000026B</basicUdiDi>
    <tradeName>Hybernite RT 19 + Elbow</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERMOREGULATED BREATHING CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPN19016BT1FTWBC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:38:31.715Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404013003686</udiDi>
    <basicUdiDi>5404013000000000000026B</basicUdiDi>
    <tradeName>Hybernite RT 15 + Elbow</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERMOREGULATED BREATHING CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPN15017BT1FTWBC</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:38:31.700Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404013003716</udiDi>
    <basicUdiDi>54040130000000000000067</basicUdiDi>
    <tradeName>Classic 19 Transparent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HUN19018T00WWGGI</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:38:31.676Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404013003730</udiDi>
    <basicUdiDi>5404013000000000000026B</basicUdiDi>
    <tradeName>Hybernite RT 114</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERMOREGULATED BREATHING CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HFN19022BT1STWGL</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:38:31.652Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404013003853</udiDi>
    <basicUdiDi>54040130000000000000067</basicUdiDi>
    <tradeName>Classic RT 12 White 10F&amp;15M/10F&amp;15M 0.40m</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HVN12D40WT0PPWBC</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:38:31.624Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404013003877</udiDi>
    <basicUdiDi>54040130000000000000067</basicUdiDi>
    <tradeName>Classic 15</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HUE15018GT0001GI</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:38:31.602Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404013004546</udiDi>
    <basicUdiDi>54040130000000000000169</basicUdiDi>
    <tradeName>-	Hybernite ROC EU</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>CPAP CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HHE19018WT0ECBCK</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:38:31.576Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404013004584</udiDi>
    <basicUdiDi>54040130000000000000067</basicUdiDi>
    <tradeName>Classic 19 CPAP Tubing</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HUE19018GT0023GI</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:38:31.553Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404013004591</udiDi>
    <basicUdiDi>54040130000000000000067</basicUdiDi>
    <tradeName>Classic 19 Transparent</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HUE19018T00023GI</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:38:31.521Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404013004607</udiDi>
    <basicUdiDi>54040130000000000000067</basicUdiDi>
    <tradeName>Classic 15</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HUE15018GT0023GI</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:38:31.497Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404013004669</udiDi>
    <basicUdiDi>54040130000000000000067</basicUdiDi>
    <tradeName>Classic FL 15 HUM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWE15018GT0051GI</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:38:31.473Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404013004676</udiDi>
    <basicUdiDi>54040130000000000000067</basicUdiDi>
    <tradeName>Classic FL 19 HUM</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>RESPIRATORY AND ANESTHESIA DEVICES - ACCESSORIES NOT INCLUDED IN OTHER CLASSES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HWE19018GT0051GI</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:38:31.448Z</lastUpdated>
  </row>
  <row>
    <udiDi>05404013004928</udiDi>
    <basicUdiDi>5404013000000000000026B</basicUdiDi>
    <tradeName>Hybernite RT12 ex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Plastiflex Group NV</manufacturerName>
    <manufacturerSrn>BE-MF-000008049</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>THERMOREGULATED BREATHING CIRCUITS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>HPN12016WT0EPWBB</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-08T20:38:31.426Z</lastUpdated>
  </row>
</eudamedExport>