<?xml version="1.0" encoding="UTF-8"?>
<eudamedExport entity="devices">
  <row>
    <udiDi>D-WB-1110L8</udiDi>
    <basicUdiDi>B-WB-1110L8</basicUdiDi>
    <tradeName>Disposable Warming Blanket</tradeName>
    <deviceName>Disposable Warming Blanket</deviceName>
    <manufacturerName>Hangzhou Tappa Medical Technology Co , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027753</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030399</emdnCode>
    <emdnDescription>HEATING COVERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WB-1110</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:30:00.242Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WB-1109LP</udiDi>
    <basicUdiDi>B-WB-1109LP</basicUdiDi>
    <tradeName>Disposable Warming Blanket</tradeName>
    <deviceName>Disposable Warming Blanket</deviceName>
    <manufacturerName>Hangzhou Tappa Medical Technology Co , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027753</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030399</emdnCode>
    <emdnDescription>HEATING COVERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WB-1109</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:29:59.423Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WB-1107LK</udiDi>
    <basicUdiDi>B-WB-1107LK</basicUdiDi>
    <tradeName>Disposable Warming Blanket</tradeName>
    <deviceName>Disposable Warming Blanket</deviceName>
    <manufacturerName>Hangzhou Tappa Medical Technology Co , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027753</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030399</emdnCode>
    <emdnDescription>HEATING COVERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WB-1107</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:29:58.616Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WB-1106LH</udiDi>
    <basicUdiDi>B-WB-1106LH</basicUdiDi>
    <tradeName>Disposable Warming Blanket</tradeName>
    <deviceName>Disposable Warming Blanket</deviceName>
    <manufacturerName>Hangzhou Tappa Medical Technology Co , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027753</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030399</emdnCode>
    <emdnDescription>HEATING COVERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WB-1106</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:29:54.617Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WB-1105LF</udiDi>
    <basicUdiDi>B-WB-1105LF</basicUdiDi>
    <tradeName>Disposable Warming Blanket</tradeName>
    <deviceName>Disposable Warming Blanket</deviceName>
    <manufacturerName>Hangzhou Tappa Medical Technology Co , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027753</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030399</emdnCode>
    <emdnDescription>HEATING COVERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WB-1105</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:29:53.826Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WB-1104LD</udiDi>
    <basicUdiDi>B-WB-1104LD</basicUdiDi>
    <tradeName>Disposable Warming Blanket</tradeName>
    <deviceName>Disposable Warming Blanket</deviceName>
    <manufacturerName>Hangzhou Tappa Medical Technology Co , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027753</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030399</emdnCode>
    <emdnDescription>HEATING COVERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WB-1104</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:29:53.019Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WB-1103LB</udiDi>
    <basicUdiDi>B-WB-1103LB</basicUdiDi>
    <tradeName>Disposable Warming Blanket</tradeName>
    <deviceName>Disposable Warming Blanket</deviceName>
    <manufacturerName>Hangzhou Tappa Medical Technology Co , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027753</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030399</emdnCode>
    <emdnDescription>HEATING COVERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WB-1103</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:29:52.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WB-1102L9</udiDi>
    <basicUdiDi>B-WB-1102L9</basicUdiDi>
    <tradeName>Disposable Warming Blanket</tradeName>
    <deviceName>Disposable Warming Blanket</deviceName>
    <manufacturerName>Hangzhou Tappa Medical Technology Co , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027753</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030399</emdnCode>
    <emdnDescription>HEATING COVERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WB-1102</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:29:49.437Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-WB-1101L7</udiDi>
    <basicUdiDi>B-WB-1101L7</basicUdiDi>
    <tradeName>Disposable Warming Blanket</tradeName>
    <deviceName>Disposable Warming Blanket</deviceName>
    <manufacturerName>Hangzhou Tappa Medical Technology Co , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027753</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030399</emdnCode>
    <emdnDescription>HEATING COVERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>WB-1101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T10:29:47.416Z</lastUpdated>
  </row>
  <row>
    <udiDi>D-TMS-W101SG</udiDi>
    <basicUdiDi>B-TMS-W101SG</basicUdiDi>
    <tradeName>Medical Warming Unit</tradeName>
    <deviceName>Medical Warming Unit</deviceName>
    <manufacturerName>Hangzhou Tappa Medical Technology Co , Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000027753</manufacturerSrn>
    <authorisedRepresentativeName>Prolinx GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005129</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIb</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030301</emdnCode>
    <emdnDescription>AIR FLOW BLANKETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>TMS-W101</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-15T07:59:31.420Z</lastUpdated>
  </row>
  <row>
    <udiDi>30612899512352</udiDi>
    <basicUdiDi>B-30612899512352</basicUdiDi>
    <tradeName>Thermoflect Leggings</tradeName>
    <deviceName>Thermoflect Leggings</deviceName>
    <manufacturerName>Encompass Group, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008638</manufacturerSrn>
    <authorisedRepresentativeName>The Surgical Company International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001974</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030399</emdnCode>
    <emdnDescription>HEATING COVERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5120-350</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:03:53.847Z</lastUpdated>
  </row>
  <row>
    <udiDi>30612899511102</udiDi>
    <basicUdiDi>B-30612899511102</basicUdiDi>
    <tradeName>Thermoflect Cap</tradeName>
    <deviceName>Thermoflect Cap, Adult</deviceName>
    <manufacturerName>Encompass Group, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008638</manufacturerSrn>
    <authorisedRepresentativeName>The Surgical Company International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001974</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030399</emdnCode>
    <emdnDescription>HEATING COVERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5110-100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:03:35.375Z</lastUpdated>
  </row>
  <row>
    <udiDi>30612899510709</udiDi>
    <basicUdiDi>B-30612899510709</basicUdiDi>
    <tradeName>Thermoflect Blanket</tradeName>
    <deviceName>Thermoflect Blanket, L</deviceName>
    <manufacturerName>Encompass Group, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008638</manufacturerSrn>
    <authorisedRepresentativeName>The Surgical Company International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001974</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030399</emdnCode>
    <emdnDescription>HEATING COVERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5100-700</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:03:34.581Z</lastUpdated>
  </row>
  <row>
    <udiDi>30612899510518</udiDi>
    <basicUdiDi>B-30612899510518</basicUdiDi>
    <tradeName>Thermoflect Pulse Oximeter Mitt</tradeName>
    <deviceName>Thermoflect Pulse Oximeter Mitt (Universal)</deviceName>
    <manufacturerName>Encompass Group, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008638</manufacturerSrn>
    <authorisedRepresentativeName>The Surgical Company International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001974</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030399</emdnCode>
    <emdnDescription>HEATING COVERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5105-100</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:03:33.770Z</lastUpdated>
  </row>
  <row>
    <udiDi>30612899510402</udiDi>
    <basicUdiDi>B-30612899510402</basicUdiDi>
    <tradeName>Thermoflect Blanket</tradeName>
    <deviceName>Thermoflect Blanket, Medium</deviceName>
    <manufacturerName>Encompass Group, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008638</manufacturerSrn>
    <authorisedRepresentativeName>The Surgical Company International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001974</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030399</emdnCode>
    <emdnDescription>HEATING COVERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5100-400</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:03:32.972Z</lastUpdated>
  </row>
  <row>
    <udiDi>30612899510259</udiDi>
    <basicUdiDi>B-30612899510259</basicUdiDi>
    <tradeName>Thermoflect Papoose</tradeName>
    <deviceName>Thermoflect Papoose</deviceName>
    <manufacturerName>Encompass Group, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008638</manufacturerSrn>
    <authorisedRepresentativeName>The Surgical Company International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001974</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030399</emdnCode>
    <emdnDescription>HEATING COVERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5100-250</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:03:28.955Z</lastUpdated>
  </row>
  <row>
    <udiDi>30612899510204</udiDi>
    <basicUdiDi>B-30612899510204</basicUdiDi>
    <tradeName>Thermoflect Blanket</tradeName>
    <deviceName>Thermoflect Blanket</deviceName>
    <manufacturerName>Encompass Group, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008638</manufacturerSrn>
    <authorisedRepresentativeName>The Surgical Company International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001974</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030399</emdnCode>
    <emdnDescription>HEATING COVERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5100-200</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:03:28.153Z</lastUpdated>
  </row>
  <row>
    <udiDi>30612899003188</udiDi>
    <basicUdiDi>B-30612899003188</basicUdiDi>
    <tradeName>Thermoflect Patient Gown</tradeName>
    <deviceName>Thermoflect Patient Gown</deviceName>
    <manufacturerName>Encompass Group, LLC</manufacturerName>
    <manufacturerSrn>US-MF-000008638</manufacturerSrn>
    <authorisedRepresentativeName>The Surgical Company International B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000001974</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030399</emdnCode>
    <emdnDescription>HEATING COVERS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5145-500</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T15:03:27.355Z</lastUpdated>
  </row>
  <row>
    <udiDi>18719867000243</udiDi>
    <basicUdiDi>8719867EMDNT030301KX</basicUdiDi>
    <tradeName>Mistral-Air® Premium Warming Suit S</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Surgical Company International B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000001973</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T030301</emdnCode>
    <emdnDescription>AIR FLOW BLANKETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MA1610</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T09:06:56.813Z</lastUpdated>
  </row>
  <row>
    <udiDi>18719867000281</udiDi>
    <basicUdiDi>8719867EMDNT030301KX</basicUdiDi>
    <tradeName>Mistral-Air® Premium Warming Suit M</tradeName>
    <deviceName></deviceName>
    <manufacturerName>The Surgical Company International B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000001973</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>T030301</emdnCode>
    <emdnDescription>AIR FLOW BLANKETS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>MA1620</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-11T09:06:56.788Z</lastUpdated>
  </row>
</eudamedExport>