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<eudamedExport entity="devices">
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    <basicUdiDi>B-07290106598430</basicUdiDi>
    <tradeName>07290106598430</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>53ND5600-MIC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:13:58.827Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290106596849</udiDi>
    <basicUdiDi>B-07290106596849</basicUdiDi>
    <tradeName>07290106596849</tradeName>
    <deviceName>Dome bag</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>53ND10065-MIC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:13:43.443Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290106596757</udiDi>
    <basicUdiDi>B-07290106596757</basicUdiDi>
    <tradeName>07290106596757</tradeName>
    <deviceName>Banded Bag</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>53ND18010T-MIC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:13:41.836Z</lastUpdated>
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  <row>
    <udiDi>07290106596726</udiDi>
    <basicUdiDi>B-07290106596726</basicUdiDi>
    <tradeName>07290106596726</tradeName>
    <deviceName>Banded bag</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>53ND17590T-MIC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:13:41.043Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290106596702</udiDi>
    <basicUdiDi>B-07290106596702</basicUdiDi>
    <tradeName>07290106596702</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>53ND2700C-MIC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:13:39.438Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290106596696</udiDi>
    <basicUdiDi>B-07290106596696</basicUdiDi>
    <tradeName>07290106596696</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>53ND2602C-MIC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:13:37.035Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290106596368</udiDi>
    <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>
  </row>
  <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>07290103849955</udiDi>
    <basicUdiDi>B-07290103849955</basicUdiDi>
    <tradeName>Protective covers</tradeName>
    <deviceName>Housse stérile pour bras porte instruments RobOtol / Sterile cover for RobOtol instrument arm 55x115</deviceName>
    <manufacturerName>Pharma-Sept Medical Products Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000037883</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80-193</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:13:20.225Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290103849948</udiDi>
    <basicUdiDi>B-07290103849948</basicUdiDi>
    <tradeName>Protective covers</tradeName>
    <deviceName>Housse interface de commande-type space mouse / Space Mouse-type control interface cover 50x70cm</deviceName>
    <manufacturerName>Pharma-Sept Medical Products Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000037883</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80-093</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:13:17.828Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290103849924</udiDi>
    <basicUdiDi>B-07290103849924</basicUdiDi>
    <tradeName>Protective covers</tradeName>
    <deviceName>foot switch cover</deviceName>
    <manufacturerName>Pharma-Sept Medical Products Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000037883</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80-080</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:13:16.240Z</lastUpdated>
  </row>
  <row>
    <udiDi>07290103849900</udiDi>
    <basicUdiDi>B-07290103849900</basicUdiDi>
    <tradeName>Protective covers</tradeName>
    <deviceName>screen cover</deviceName>
    <manufacturerName>Pharma-Sept Medical Products Ltd.</manufacturerName>
    <manufacturerSrn>IL-MF-000037883</manufacturerSrn>
    <authorisedRepresentativeName>Obelis s.a.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000106</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>80-189</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:13:15.433Z</lastUpdated>
  </row>
</eudamedExport>