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<eudamedExport entity="devices">
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    <basicUdiDi>B-07290106596368</basicUdiDi>
    <tradeName>07290106596368</tradeName>
    <deviceName>C-ARM COVER</deviceName>
    <manufacturerName>SION BIOTEXT MEDICAL LTD.</manufacturerName>
    <manufacturerSrn>IL-MF-000012169</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>53ND5410-MIC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:13:35.436Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290106596665</udiDi>
    <basicUdiDi>B-07290106596665</basicUdiDi>
    <tradeName>07290106596665</tradeName>
    <deviceName>Probe Cover</deviceName>
    <manufacturerName>SION BIOTEXT MEDICAL LTD.</manufacturerName>
    <manufacturerSrn>IL-MF-000012169</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>53ND2600C-MIC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:13:34.648Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290106596344</udiDi>
    <basicUdiDi>B-07290106596344</basicUdiDi>
    <tradeName>07290106596344</tradeName>
    <deviceName>C-ARM COVER</deviceName>
    <manufacturerName>SION BIOTEXT MEDICAL LTD.</manufacturerName>
    <manufacturerSrn>IL-MF-000012169</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>53ND5400</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:13:33.030Z</lastUpdated>
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  <row>
    <udiDi>07290106596337</udiDi>
    <basicUdiDi>B-07290106596337</basicUdiDi>
    <tradeName>07290106596337</tradeName>
    <deviceName>C-ARM COVER</deviceName>
    <manufacturerName>SION BIOTEXT MEDICAL LTD.</manufacturerName>
    <manufacturerSrn>IL-MF-000012169</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>53ND5400-MIC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:13:30.947Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290106594708</udiDi>
    <basicUdiDi>B-07290106594708</basicUdiDi>
    <tradeName>07290106594708</tradeName>
    <deviceName>UNI COVER</deviceName>
    <manufacturerName>SION BIOTEXT MEDICAL LTD.</manufacturerName>
    <manufacturerSrn>IL-MF-000012169</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>53NS0111001C, 53NS0111001B-LB, 53NS0111001C-LB</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:13:29.036Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290106594500</udiDi>
    <basicUdiDi>B-07290106594500</basicUdiDi>
    <tradeName>07290106594500</tradeName>
    <deviceName>C-ARM COVER</deviceName>
    <manufacturerName>SION BIOTEXT MEDICAL LTD.</manufacturerName>
    <manufacturerSrn>IL-MF-000012169</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>53ND5150</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:13:28.227Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290106590366</udiDi>
    <basicUdiDi>B-07290106590366</basicUdiDi>
    <tradeName>07290106590366</tradeName>
    <deviceName>PROBE COVER</deviceName>
    <manufacturerName>SION BIOTEXT MEDICAL LTD.</manufacturerName>
    <manufacturerSrn>IL-MF-000012169</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>53ND2705C-MIC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:13:26.635Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290106590304</udiDi>
    <basicUdiDi>B-07290106590304</basicUdiDi>
    <tradeName>07290106590304</tradeName>
    <deviceName>Probe Cover</deviceName>
    <manufacturerName>SION BIOTEXT MEDICAL LTD.</manufacturerName>
    <manufacturerSrn>IL-MF-000012169</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>53ND2601C-MIC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:13:24.226Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290106590045</udiDi>
    <basicUdiDi>B-07290106590045</basicUdiDi>
    <tradeName>07290106590045</tradeName>
    <deviceName>Microscope cover</deviceName>
    <manufacturerName>SION BIOTEXT MEDICAL LTD.</manufacturerName>
    <manufacturerSrn>IL-MF-000012169</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>53ND86185</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:13:22.631Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290106590007</udiDi>
    <basicUdiDi>B-07290106590007</basicUdiDi>
    <tradeName>07290106590007</tradeName>
    <deviceName>Light handle cover</deviceName>
    <manufacturerName>SION BIOTEXT MEDICAL LTD.</manufacturerName>
    <manufacturerSrn>IL-MF-000012169</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>53NS01300C</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:13:21.882Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290101427919</udiDi>
    <basicUdiDi>B-07290101427919</basicUdiDi>
    <tradeName>07290101427919</tradeName>
    <deviceName>Sterile embossed non woven medical baby towel</deviceName>
    <manufacturerName>SION BIOTEXT MEDICAL LTD.</manufacturerName>
    <manufacturerSrn>IL-MF-000012169</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M020299</emdnCode>
    <emdnDescription>NON-WOVEN GAUZES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>098714RN</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:11:40.259Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290101427902</udiDi>
    <basicUdiDi>B-07290101427902</basicUdiDi>
    <tradeName>07290101427902</tradeName>
    <deviceName>Sterile non woven medical hand towel</deviceName>
    <manufacturerName>SION BIOTEXT MEDICAL LTD.</manufacturerName>
    <manufacturerSrn>IL-MF-000012169</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M020299</emdnCode>
    <emdnDescription>NON-WOVEN GAUZES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>098024RN</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:11:38.668Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290101427896</udiDi>
    <basicUdiDi>B-07290101427896</basicUdiDi>
    <tradeName>07290101427896</tradeName>
    <deviceName>Sterile non woven medical hand towel</deviceName>
    <manufacturerName>SION BIOTEXT MEDICAL LTD.</manufacturerName>
    <manufacturerSrn>IL-MF-000012169</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M020299</emdnCode>
    <emdnDescription>NON-WOVEN GAUZES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>098014RN</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:11:37.851Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290101427445</udiDi>
    <basicUdiDi>B-07290101427445</basicUdiDi>
    <tradeName>07290101427445</tradeName>
    <deviceName>C-BOW COVER</deviceName>
    <manufacturerName>SION BIOTEXT MEDICAL LTD.</manufacturerName>
    <manufacturerSrn>IL-MF-000012169</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>53ND5604-MIC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:11:36.251Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290101427001</udiDi>
    <basicUdiDi>B-07290101427001</basicUdiDi>
    <tradeName>07290101427001</tradeName>
    <deviceName>Microscope cover</deviceName>
    <manufacturerName>SION BIOTEXT MEDICAL LTD.</manufacturerName>
    <manufacturerSrn>IL-MF-000012169</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>53ND96300</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:11:33.856Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290100665077</udiDi>
    <basicUdiDi>B-07290100665077</basicUdiDi>
    <tradeName>07290100665077</tradeName>
    <deviceName>Sterile Lubricant Jelly</deviceName>
    <manufacturerName>SION BIOTEXT MEDICAL LTD.</manufacturerName>
    <manufacturerSrn>IL-MF-000012169</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>53J505-8000-000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:11:32.259Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290100663301</udiDi>
    <basicUdiDi>B-07290100663301</basicUdiDi>
    <tradeName>07290100663301</tradeName>
    <deviceName>Sterile Lubricating Jelly</deviceName>
    <manufacturerName>SION BIOTEXT MEDICAL LTD.</manufacturerName>
    <manufacturerSrn>IL-MF-000012169</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>M9002</emdnCode>
    <emdnDescription>PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>53J805-5001-000A</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:11:31.654Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290108301908</udiDi>
    <basicUdiDi>729010142SBBFB</basicUdiDi>
    <tradeName>Soft Biteblock</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SION BIOTEXT MEDICAL LTD.</manufacturerName>
    <manufacturerSrn>IL-MF-000012169</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>54D260-260003</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:50:22.982Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290108301915</udiDi>
    <basicUdiDi>729010142SBBFB</basicUdiDi>
    <tradeName>Soft Biteblock</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SION BIOTEXT MEDICAL LTD.</manufacturerName>
    <manufacturerSrn>IL-MF-000012169</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>54D260-260004</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:50:18.896Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290108301922</udiDi>
    <basicUdiDi>729010142SBBFB</basicUdiDi>
    <tradeName>Soft Biteblock</tradeName>
    <deviceName></deviceName>
    <manufacturerName>SION BIOTEXT MEDICAL LTD.</manufacturerName>
    <manufacturerSrn>IL-MF-000012169</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>54D260-260005</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:50:17.182Z</lastUpdated>
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