<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>00801741184284</udiDi>
    <basicUdiDi>0801741VZGZLHYZHK</basicUdiDi>
    <tradeName>ARCTIC SUN</tradeName>
    <deviceName>Arctic Sun STAT Temperature Management System</deviceName>
    <manufacturerName>Medivance, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000018886</manufacturerSrn>
    <authorisedRepresentativeName>Becton Dickinson Ireland Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000007610</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040208</emdnCode>
    <emdnDescription>BODY THERMOREGULATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>73901</reference>
    <placedOnMarketCountry>Belgium</placedOnMarketCountry>
    <lastUpdated>2026-07-31T19:48:00.820Z</lastUpdated>
  </row>
  <row>
    <udiDi>06429810144133</udiDi>
    <basicUdiDi>6429810144H5000QW</basicUdiDi>
    <tradeName>CVN Arctic Pallas Hypothermia Bag</tradeName>
    <deviceName>CVN Arctic</deviceName>
    <manufacturerName>CVN medical Oy</manufacturerName>
    <manufacturerSrn>FI-MF-000032554</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040208</emdnCode>
    <emdnDescription>BODY THERMOREGULATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>H5000-5016P</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T14:37:59.450Z</lastUpdated>
  </row>
  <row>
    <udiDi>05060297210006</udiDi>
    <basicUdiDi>506029721BPSRangeBC</basicUdiDi>
    <tradeName>05060297210006</tradeName>
    <deviceName>Blizzard Trauma Blanket</deviceName>
    <manufacturerName>Blizzard Protection Systems Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000005673</manufacturerSrn>
    <authorisedRepresentativeName>Comply Express Lda</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>PT-AR-000004357</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040208</emdnCode>
    <emdnDescription>BODY THERMOREGULATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:42:27.271Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262481810134</udiDi>
    <basicUdiDi>426248181HYPOCIRCUITHJ</basicUdiDi>
    <tradeName>HYPO Circuit</tradeName>
    <deviceName>HYPO Circuit</deviceName>
    <manufacturerName>LAUDA Medical GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000027737</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040208</emdnCode>
    <emdnDescription>BODY THERMOREGULATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>LM000362</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:41:07.206Z</lastUpdated>
  </row>
  <row>
    <udiDi>04262481810011</udiDi>
    <basicUdiDi>426248181HYPODY</basicUdiDi>
    <tradeName>HYPO</tradeName>
    <deviceName>HYPO</deviceName>
    <manufacturerName>LAUDA Medical GmbH &amp; Co. KG</manufacturerName>
    <manufacturerSrn>DE-MF-000027737</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040208</emdnCode>
    <emdnDescription>BODY THERMOREGULATION EQUIPMENT</emdnDescription>
    <deviceStatus>AB pazarı için değil</deviceStatus>
    <reference>LM000201</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-31T02:41:03.188Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250478403797</udiDi>
    <basicUdiDi>42504784565NR</basicUdiDi>
    <tradeName>04250478403797</tradeName>
    <deviceName>Kalt-Warm-Kompresse</deviceName>
    <manufacturerName>BODY PRODUCTS RELAX Pharma und Kosmetik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005302</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040208</emdnCode>
    <emdnDescription>BODY THERMOREGULATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N18861</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:37:55.216Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250478403599</udiDi>
    <basicUdiDi>42504784565NR</basicUdiDi>
    <tradeName>04250478403599</tradeName>
    <deviceName>Kalt-Warm-Kompresse</deviceName>
    <manufacturerName>BODY PRODUCTS RELAX Pharma und Kosmetik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005302</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040208</emdnCode>
    <emdnDescription>BODY THERMOREGULATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N19052</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-30T21:33:58.963Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290012127182</udiDi>
    <basicUdiDi>08961280020000128J</basicUdiDi>
    <tradeName>CureWrap® Infant, 2.5-4Kg</tradeName>
    <deviceName>CureWraps</deviceName>
    <manufacturerName>Belmont Medical Technologies</manufacturerName>
    <manufacturerSrn>US-MF-000007062</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040208</emdnCode>
    <emdnDescription>BODY THERMOREGULATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>500-03518</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-20T19:53:51.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>77290012127174</udiDi>
    <basicUdiDi>08961280020000128J</basicUdiDi>
    <tradeName>CureWrap® Adult Over 135 cm</tradeName>
    <deviceName>CureWraps</deviceName>
    <manufacturerName>Belmont Medical Technologies</manufacturerName>
    <manufacturerSrn>US-MF-000007062</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040208</emdnCode>
    <emdnDescription>BODY THERMOREGULATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>504-03500</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-17T02:20:11.655Z</lastUpdated>
  </row>
  <row>
    <udiDi>06958627550252</udiDi>
    <basicUdiDi>69586275GT084-200XS</basicUdiDi>
    <tradeName>Thermal Accident Blanket</tradeName>
    <deviceName>Thermal Accident Blanket</deviceName>
    <manufacturerName>Ningbo Greetmed Medical Instruments Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000009634</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040208</emdnCode>
    <emdnDescription>BODY THERMOREGULATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>GT084-200A</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-16T07:52:26.292Z</lastUpdated>
  </row>
  <row>
    <udiDi>04250478403919</udiDi>
    <basicUdiDi>42504784565NR</basicUdiDi>
    <tradeName>04250478403919</tradeName>
    <deviceName>Kalt-Warm-Kompresse</deviceName>
    <manufacturerName>BODY PRODUCTS RELAX Pharma und Kosmetik GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005302</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040208</emdnCode>
    <emdnDescription>BODY THERMOREGULATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>N18865</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-16T05:58:11.787Z</lastUpdated>
  </row>
  <row>
    <udiDi>06973801763044</udiDi>
    <basicUdiDi>06973801760531UG</basicUdiDi>
    <tradeName>Patient Warming System</tradeName>
    <deviceName>Patient Warming System</deviceName>
    <manufacturerName>Beijing Medkon Medical Devices Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027538</manufacturerSrn>
    <authorisedRepresentativeName>MedPath GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000087</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040208</emdnCode>
    <emdnDescription>BODY THERMOREGULATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TM-AWS2000</reference>
    <placedOnMarketCountry>Poland</placedOnMarketCountry>
    <lastUpdated>2026-07-15T22:15:07.789Z</lastUpdated>
  </row>
  <row>
    <udiDi>10610586043321</udiDi>
    <basicUdiDi>0610586M0079DK</basicUdiDi>
    <tradeName>Snuggle Warm Adult Full Body Convective Warming Blanket</tradeName>
    <deviceName>Snuggle Warm Patient Warming Blankets</deviceName>
    <manufacturerName>ICU Medical, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000002566</manufacturerSrn>
    <authorisedRepresentativeName>ICU Medical BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002748</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>Z12040208</emdnCode>
    <emdnDescription>BODY THERMOREGULATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SWU-2001</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-15T21:59:53.441Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-869943628WKQ3C</udiDi>
    <basicUdiDi>B-869943628WKQ3C</basicUdiDi>
    <tradeName>Medwarm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>İSTANBUL MEDİKAL LTD.ŞTİ</manufacturerName>
    <manufacturerSrn>TR-MF-000017249</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12040208</emdnCode>
    <emdnDescription>BODY THERMOREGULATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>W-300</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:03:11.121Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-869943628PKAZ6</udiDi>
    <basicUdiDi>B-869943628PKAZ6</basicUdiDi>
    <tradeName>Medwarm</tradeName>
    <deviceName></deviceName>
    <manufacturerName>İSTANBUL MEDİKAL LTD.ŞTİ</manufacturerName>
    <manufacturerSrn>TR-MF-000017249</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>Z12040208</emdnCode>
    <emdnDescription>BODY THERMOREGULATION EQUIPMENT</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>IM-190MS</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-12T17:03:06.980Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8057502900156ZR</udiDi>
    <basicUdiDi>B-8057502900156ZR</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 4.0</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:48:50.383Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-8057502900149ZU</udiDi>
    <basicUdiDi>B-8057502900149ZU</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>TRMMEDP4.0</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:48:48.783Z</lastUpdated>
  </row>
  <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>
</eudamedExport>