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    <basicUdiDi>729010142ABSDK</basicUdiDi>
    <tradeName>07290108301595</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>54D101-101106</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:49:33.584Z</lastUpdated>
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    <udiDi>07290108301632</udiDi>
    <basicUdiDi>729010142ABSDK</basicUdiDi>
    <tradeName>07290108301632</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>54D101-101107</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-06T19:49:08.433Z</lastUpdated>
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    <udiDi>08997030302001</udiDi>
    <basicUdiDi>899703030NRSGRV</basicUdiDi>
    <tradeName>DURASENSE</tradeName>
    <deviceName>Powder Free Natural Rubber Latex Sterile Surgical Gloves</deviceName>
    <manufacturerName>PT. Medisafe Technologies</manufacturerName>
    <manufacturerSrn>ID-MF-000017133</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010102</emdnCode>
    <emdnDescription>NON-POWDERED LATEX SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>NR-SG-127</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:44:08.429Z</lastUpdated>
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    <udiDi>08997030300175</udiDi>
    <basicUdiDi>899703030CRSGPG</basicUdiDi>
    <tradeName>CHLOROSENSE</tradeName>
    <deviceName>Powder Free Polychloroprene Sterile Surgical Gloves</deviceName>
    <manufacturerName>PT. Medisafe Technologies</manufacturerName>
    <manufacturerSrn>ID-MF-000017133</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010201</emdnCode>
    <emdnDescription>POLYCHLOROPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR-SG-130-WH</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:44:07.645Z</lastUpdated>
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    <udiDi>08997030302025</udiDi>
    <basicUdiDi>899703030IRSGQS</basicUdiDi>
    <tradeName>Isosense</tradeName>
    <deviceName>Powder Free Polyisoprene Sterile Surgical Gloves</deviceName>
    <manufacturerName>PT. Medisafe Technologies</manufacturerName>
    <manufacturerSrn>ID-MF-000017133</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010203</emdnCode>
    <emdnDescription>POLYISOPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>Powder Free Polyisoprene Sterile Surgical Gloves, Size 6 (1R-SG-119-WH)</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T20:44:06.021Z</lastUpdated>
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    <udiDi>07290106599697</udiDi>
    <basicUdiDi>729010142NSCG7</basicUdiDi>
    <tradeName>07290106599697</tradeName>
    <deviceName>MIC.COVER MOELLER 6.5-115*220CM-HD</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>MDR 2017/745</legislation>
    <emdnCode>T030199</emdnCode>
    <emdnDescription>COVERS, INSTRUMENTS AND EQUIPMENT - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>51NS0111001B-MIC</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:27:19.502Z</lastUpdated>
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    <udiDi>07290101427803</udiDi>
    <basicUdiDi>729010142WIPEAV</basicUdiDi>
    <tradeName>BARRIER WIPE 100pk x 20bx SION CEE</tradeName>
    <deviceName>Impregnated wipes</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>MDR 2017/745</legislation>
    <emdnCode>A108004</emdnCode>
    <emdnDescription>PROTECTIVE FILMS / SPRAYS FOR PERISTOMAL SKIN</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>54W211-1206-913</reference>
    <placedOnMarketCountry>Latvia</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:25:05.711Z</lastUpdated>
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    <udiDi>07290101424567</udiDi>
    <basicUdiDi>729010142NSDG9</basicUdiDi>
    <tradeName>07290101424567</tradeName>
    <deviceName>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>MDR 2017/745</legislation>
    <emdnCode>M020299</emdnCode>
    <emdnDescription>NON-WOVEN GAUZES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>098204RN</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:25:04.893Z</lastUpdated>
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    <udiDi>07290100667439</udiDi>
    <basicUdiDi>729010142LGSFR</basicUdiDi>
    <tradeName>07290100667439</tradeName>
    <deviceName>Lemon Glycerin Swabsticks</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>MDR 2017/745</legislation>
    <emdnCode>V9099</emdnCode>
    <emdnDescription>VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>54W403-6234-000</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-02T22:25:00.200Z</lastUpdated>
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    <udiDi>05060408221259</udiDi>
    <basicUdiDi>5060408222104Q</basicUdiDi>
    <tradeName>Suportx</tradeName>
    <deviceName>15cm Easy Peel Belt</deviceName>
    <manufacturerName>AMI Medical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000016718</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ABDOMINAL HERNIA SUPPORTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPX706</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:13:48.455Z</lastUpdated>
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    <udiDi>05060408221082</udiDi>
    <basicUdiDi>5060408222054X</basicUdiDi>
    <tradeName>Suportx</tradeName>
    <deviceName>20Cm Suportx Easy Peel</deviceName>
    <manufacturerName>AMI Medical Limited</manufacturerName>
    <manufacturerSrn>GB-MF-000016718</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>ABDOMINAL HERNIA SUPPORTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SPX711W</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-01T23:13:47.656Z</lastUpdated>
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  <row>
    <udiDi>08997030300182</udiDi>
    <basicUdiDi>899703030CRSGPG</basicUdiDi>
    <tradeName>CHLOROSENSE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PT. Medisafe Technologies</manufacturerName>
    <manufacturerSrn>ID-MF-000017133</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010201</emdnCode>
    <emdnDescription>POLYCHLOROPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR-SG-130-WH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:14:57.844Z</lastUpdated>
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    <udiDi>08997030300199</udiDi>
    <basicUdiDi>899703030CRSGPG</basicUdiDi>
    <tradeName>CHLOROSENSE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PT. Medisafe Technologies</manufacturerName>
    <manufacturerSrn>ID-MF-000017133</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010201</emdnCode>
    <emdnDescription>POLYCHLOROPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR-SG-130-WH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:14:57.828Z</lastUpdated>
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    <udiDi>08997030300205</udiDi>
    <basicUdiDi>899703030CRSGPG</basicUdiDi>
    <tradeName>CHLOROSENSE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PT. Medisafe Technologies</manufacturerName>
    <manufacturerSrn>ID-MF-000017133</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010201</emdnCode>
    <emdnDescription>POLYCHLOROPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR-SG-130-WH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:14:57.816Z</lastUpdated>
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    <udiDi>08997030300212</udiDi>
    <basicUdiDi>899703030CRSGPG</basicUdiDi>
    <tradeName>CHLOROSENSE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PT. Medisafe Technologies</manufacturerName>
    <manufacturerSrn>ID-MF-000017133</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010201</emdnCode>
    <emdnDescription>POLYCHLOROPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR-SG-130-WH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:14:57.796Z</lastUpdated>
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    <udiDi>08997030300229</udiDi>
    <basicUdiDi>899703030CRSGPG</basicUdiDi>
    <tradeName>CHLOROSENSE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PT. Medisafe Technologies</manufacturerName>
    <manufacturerSrn>ID-MF-000017133</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
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    <emdnCode>T01010201</emdnCode>
    <emdnDescription>POLYCHLOROPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR-SG-130-WH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:14:57.771Z</lastUpdated>
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    <basicUdiDi>899703030CRSGPG</basicUdiDi>
    <tradeName>CHLOROSENSE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PT. Medisafe Technologies</manufacturerName>
    <manufacturerSrn>ID-MF-000017133</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010201</emdnCode>
    <emdnDescription>POLYCHLOROPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR-SG-130-WH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:14:57.749Z</lastUpdated>
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    <basicUdiDi>899703030CRSGPG</basicUdiDi>
    <tradeName>CHLOROSENSE</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PT. Medisafe Technologies</manufacturerName>
    <manufacturerSrn>ID-MF-000017133</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
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    <emdnDescription>POLYCHLOROPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR-SG-130-WH</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:14:57.718Z</lastUpdated>
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    <udiDi>08997030300250</udiDi>
    <basicUdiDi>899703030CRSGPG</basicUdiDi>
    <tradeName>CHLOROSENSE OPTIMA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PT. Medisafe Technologies</manufacturerName>
    <manufacturerSrn>ID-MF-000017133</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000006691</authorisedRepresentativeSrn>
    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010201</emdnCode>
    <emdnDescription>POLYCHLOROPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR-SG-135-LG-CR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:14:57.697Z</lastUpdated>
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    <udiDi>08997030300267</udiDi>
    <basicUdiDi>899703030CRSGPG</basicUdiDi>
    <tradeName>CHLOROSENSE OPTIMA</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PT. Medisafe Technologies</manufacturerName>
    <manufacturerSrn>ID-MF-000017133</manufacturerSrn>
    <authorisedRepresentativeName>Theo Manufacturing B.V.</authorisedRepresentativeName>
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    <riskClass>Sınıf IIa</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>T01010201</emdnCode>
    <emdnDescription>POLYCHLOROPREN SURGICAL GLOVES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CR-SG-135-LG-CR</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-01T08:14:57.680Z</lastUpdated>
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