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    <manufacturerName>Savantini Ltd</manufacturerName>
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    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>VAGINAL DILATORS, REUSABLE</emdnDescription>
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    <reference>13928-SIZE1</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:47:16.429Z</lastUpdated>
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    <tradeName>Maxhim</tradeName>
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    <manufacturerName>Savantini Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000011959</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
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    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:47:15.631Z</lastUpdated>
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    <tradeName>Kegel8</tradeName>
    <deviceName>Set</deviceName>
    <manufacturerName>Savantini Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000011959</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
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    <emdnDescription>RECTAL AND ANAL SPREADERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13965</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:47:14.828Z</lastUpdated>
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    <tradeName>Kegel8</tradeName>
    <deviceName>Kegel8 Pelvic Therapy Wand</deviceName>
    <manufacturerName>Savantini Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000011959</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>MDR 2017/745</legislation>
    <emdnCode>U0899</emdnCode>
    <emdnDescription>GYNAECOLOGICAL DEVICES - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13963</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-01T22:47:14.033Z</lastUpdated>
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    <basicUdiDi>505589691396584</basicUdiDi>
    <tradeName>Kegel8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Savantini Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000011959</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L040902</emdnCode>
    <emdnDescription>RECTAL AND ANAL SPREADERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13965-SIZE5</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T08:51:55.938Z</lastUpdated>
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    <tradeName>Kegel8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Savantini Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000011959</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L040902</emdnCode>
    <emdnDescription>RECTAL AND ANAL SPREADERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13965-SIZE4</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T08:51:55.030Z</lastUpdated>
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    <tradeName>Kegel8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Savantini Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000011959</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L040902</emdnCode>
    <emdnDescription>RECTAL AND ANAL SPREADERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13965-SIZE3</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T08:51:53.239Z</lastUpdated>
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    <tradeName>Kegel8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Savantini Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000011959</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L040902</emdnCode>
    <emdnDescription>RECTAL AND ANAL SPREADERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13965-SIZE2</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T08:51:52.337Z</lastUpdated>
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    <tradeName>Kegel8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Savantini Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000011959</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L040902</emdnCode>
    <emdnDescription>RECTAL AND ANAL SPREADERS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13965-SIZE1</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-19T08:51:51.572Z</lastUpdated>
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    <basicUdiDi>50558969139287W</basicUdiDi>
    <tradeName>Kegel8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Savantini Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000011959</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0509020101</emdnCode>
    <emdnDescription>VAGINAL DILATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13928-SET</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-19T08:51:49.624Z</lastUpdated>
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    <tradeName>Kegel8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Savantini Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000011959</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0509020101</emdnCode>
    <emdnDescription>VAGINAL DILATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13928-SIZE5</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-19T08:51:48.727Z</lastUpdated>
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    <basicUdiDi>50558969139287W</basicUdiDi>
    <tradeName>Kegel8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Savantini Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000011959</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0509020101</emdnCode>
    <emdnDescription>VAGINAL DILATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13928-SIZE4</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-19T08:51:46.922Z</lastUpdated>
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    <basicUdiDi>50558969139287W</basicUdiDi>
    <tradeName>Kegel8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Savantini Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000011959</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0509020101</emdnCode>
    <emdnDescription>VAGINAL DILATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13928-SIZE3</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-19T08:51:46.022Z</lastUpdated>
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    <basicUdiDi>50558969139287W</basicUdiDi>
    <tradeName>Kegel8</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Savantini Ltd</manufacturerName>
    <manufacturerSrn>GB-MF-000011959</manufacturerSrn>
    <authorisedRepresentativeName>European Healthcare &amp; Device Solutions Ltd.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>IE-AR-000003999</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>L0509020101</emdnCode>
    <emdnDescription>VAGINAL DILATORS, REUSABLE</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>13928-SIZE2</reference>
    <placedOnMarketCountry>Austria</placedOnMarketCountry>
    <lastUpdated>2026-06-19T08:51:44.229Z</lastUpdated>
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