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    <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>54D101-101108</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:46:34.351Z</lastUpdated>
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    <udiDi>07290108301656</udiDi>
    <basicUdiDi>729010142ABSDK</basicUdiDi>
    <tradeName>07290108301656</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>54D101-101109</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:46:32.996Z</lastUpdated>
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    <udiDi>07290108302837</udiDi>
    <basicUdiDi>B-07290108302837</basicUdiDi>
    <tradeName>07290108302837</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>53NS2223</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:16:28.182Z</lastUpdated>
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    <udiDi>07290108302523</udiDi>
    <basicUdiDi>B-07290108302523</basicUdiDi>
    <tradeName>07290108302523</tradeName>
    <deviceName>C-ARM UNI PROTECTION 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>53ND22709C-MIC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:16:27.218Z</lastUpdated>
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  <row>
    <udiDi>07290108300475</udiDi>
    <basicUdiDi>B-07290108300475</basicUdiDi>
    <tradeName>07290108300475</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>53ND5600S-MIC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:16:26.432Z</lastUpdated>
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  <row>
    <udiDi>07290106599635</udiDi>
    <basicUdiDi>B-07290106599635</basicUdiDi>
    <tradeName>07290106599635</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>53NS0111001A-MIC, 53NS0111001-MIC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:14:12.317Z</lastUpdated>
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    <udiDi>07290106599574</udiDi>
    <basicUdiDi>B-07290106599574</basicUdiDi>
    <tradeName>07290106599574</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>53ND5152T-MIC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:14:11.519Z</lastUpdated>
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  <row>
    <udiDi>07290106599420</udiDi>
    <basicUdiDi>B-07290106599420</basicUdiDi>
    <tradeName>07290106599420</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>53ND5210T-MIC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:14:10.709Z</lastUpdated>
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    <udiDi>07290106599369</udiDi>
    <basicUdiDi>B-07290106599369</basicUdiDi>
    <tradeName>07290106599369</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>53ND5200T-MIC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:14:06.712Z</lastUpdated>
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  <row>
    <udiDi>07290106599307</udiDi>
    <basicUdiDi>B-07290106599307</basicUdiDi>
    <tradeName>07290106599307</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>53ND5150T-MIC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:14:05.910Z</lastUpdated>
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  <row>
    <udiDi>07290106599277</udiDi>
    <basicUdiDi>B-07290106599277</basicUdiDi>
    <tradeName>07290106599277</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>53ND5550T-MIC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:14:05.109Z</lastUpdated>
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  <row>
    <udiDi>07290106599246</udiDi>
    <basicUdiDi>B-07290106599246</basicUdiDi>
    <tradeName>07290106599246</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>53ND5340T-MIC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:14:04.309Z</lastUpdated>
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  <row>
    <udiDi>07290106597686</udiDi>
    <basicUdiDi>B-07290106597686</basicUdiDi>
    <tradeName>07290106597686</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>53ND86220</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:14:00.306Z</lastUpdated>
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  <row>
    <udiDi>07290106599215</udiDi>
    <basicUdiDi>B-07290106599215</basicUdiDi>
    <tradeName>07290106599215</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>53ND5342T-MIC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-07T00:13:59.522Z</lastUpdated>
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  <row>
    <udiDi>07290106598430</udiDi>
    <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>
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  <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>
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  <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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    <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>
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  <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>
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  <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>
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