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    <authorisedRepresentativeName>BEO MedConsulting Berlin GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006764</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1257-2939-300_054</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:46:09.128Z</lastUpdated>
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    <basicUdiDi>8594072950PAN5.07P4</basicUdiDi>
    <tradeName>PAN5.07 Ortéza zápěstí Rigidux krátká M-pravá</tradeName>
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    <manufacturerName>PANOP CZ s.r.o.</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <tradeName>Spex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spex Ltd</manufacturerName>
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    <authorisedRepresentativeName>BEO MedConsulting Berlin GmbH</authorisedRepresentativeName>
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    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
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    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:46:09.085Z</lastUpdated>
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    <basicUdiDi>B-00686597200636</basicUdiDi>
    <tradeName>INSTI HIV Self Test (no pipette variant, packaged in a box)</tradeName>
    <deviceName></deviceName>
    <manufacturerName>bioLytical Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000023304</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Ek II Liste A</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription>HIV MULTIPLE ANTIBODY</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>90-1059-001 and 90-1059-002</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
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    <udiDi>09420082905986</udiDi>
    <basicUdiDi>94200517BACKSUPPORTFL</basicUdiDi>
    <tradeName>Spex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spex Ltd</manufacturerName>
    <manufacturerSrn>NZ-MF-000009327</manufacturerSrn>
    <authorisedRepresentativeName>BEO MedConsulting Berlin GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006764</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1257-2939-300_060</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:46:09.036Z</lastUpdated>
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    <udiDi>08594072959653</udiDi>
    <basicUdiDi>8594072950PAN5.07P4</basicUdiDi>
    <tradeName>PAN5.07 Ortéza zápěstí Rigidux krátká S-levá</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PANOP CZ s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000025007</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PAN5.07/I/S-le</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <udiDi>09420082905993</udiDi>
    <basicUdiDi>94200517BACKSUPPORTFL</basicUdiDi>
    <tradeName>Spex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spex Ltd</manufacturerName>
    <manufacturerSrn>NZ-MF-000009327</manufacturerSrn>
    <authorisedRepresentativeName>BEO MedConsulting Berlin GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006764</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1257-2939-300_077</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:46:09.000Z</lastUpdated>
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    <udiDi>00870053000384</udiDi>
    <basicUdiDi>B-00870053000384</basicUdiDi>
    <tradeName>ChitoGauze XR PRO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tricol Biomedical Inc</manufacturerName>
    <manufacturerSrn>US-MF-000002003</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1090 (FR)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:46:08.984Z</lastUpdated>
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    <udiDi>09420082906181</udiDi>
    <basicUdiDi>94200517BACKSUPPORTFL</basicUdiDi>
    <tradeName>Spex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spex Ltd</manufacturerName>
    <manufacturerSrn>NZ-MF-000009327</manufacturerSrn>
    <authorisedRepresentativeName>BEO MedConsulting Berlin GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006764</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1257-2939-3F0</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:46:08.969Z</lastUpdated>
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    <basicUdiDi>8594072950PAN5.07P4</basicUdiDi>
    <tradeName>PAN5.07 Ortéza zápěstí Rigidux krátká S-praváv</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PANOP CZ s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000025007</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PAN5.07/I/S-pr</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:46:08.953Z</lastUpdated>
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    <udiDi>09420082924604</udiDi>
    <basicUdiDi>94200517BACKSUPPORTFL</basicUdiDi>
    <tradeName>Spex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spex Ltd</manufacturerName>
    <manufacturerSrn>NZ-MF-000009327</manufacturerSrn>
    <authorisedRepresentativeName>BEO MedConsulting Berlin GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006764</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1257-2939-3F0_044</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:46:08.911Z</lastUpdated>
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    <udiDi>00870053000438</udiDi>
    <basicUdiDi>B-00870053000438</basicUdiDi>
    <tradeName>ChitoGauze XR PRO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tricol Biomedical Inc</manufacturerName>
    <manufacturerSrn>US-MF-000002003</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1090 (IT)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:46:08.882Z</lastUpdated>
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    <udiDi>09420082922884</udiDi>
    <basicUdiDi>94200517BACKSUPPORTFL</basicUdiDi>
    <tradeName>Spex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spex Ltd</manufacturerName>
    <manufacturerSrn>NZ-MF-000009327</manufacturerSrn>
    <authorisedRepresentativeName>BEO MedConsulting Berlin GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006764</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1257-2939-3F0_028</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:46:08.864Z</lastUpdated>
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    <udiDi>09420082922341</udiDi>
    <basicUdiDi>94200517BACKSUPPORTFL</basicUdiDi>
    <tradeName>Spex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spex Ltd</manufacturerName>
    <manufacturerSrn>NZ-MF-000009327</manufacturerSrn>
    <authorisedRepresentativeName>BEO MedConsulting Berlin GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006764</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1257-2939-3F0_022</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:46:08.838Z</lastUpdated>
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    <udiDi>09420082922914</udiDi>
    <basicUdiDi>94200517BACKSUPPORTFL</basicUdiDi>
    <tradeName>Spex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spex Ltd</manufacturerName>
    <manufacturerSrn>NZ-MF-000009327</manufacturerSrn>
    <authorisedRepresentativeName>BEO MedConsulting Berlin GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006764</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1257-2939-3F0_090</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:46:08.821Z</lastUpdated>
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    <basicUdiDi>8594072950PAN5.07P4</basicUdiDi>
    <tradeName>PAN5.07 Ortéza zápěstí Rigidux dlouhá L-levá</tradeName>
    <deviceName></deviceName>
    <manufacturerName>PANOP CZ s.r.o.</manufacturerName>
    <manufacturerSrn>CZ-MF-000025007</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>PAN5.07/II/L-le</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:46:08.806Z</lastUpdated>
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    <tradeName>ChitoGauze XR PRO</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Tricol Biomedical Inc</manufacturerName>
    <manufacturerSrn>US-MF-000002003</manufacturerSrn>
    <authorisedRepresentativeName>AR Experts B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000023989</authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1090 (DE)</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:46:08.789Z</lastUpdated>
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    <basicUdiDi>94200517BACKSUPPORTFL</basicUdiDi>
    <tradeName>Spex</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Spex Ltd</manufacturerName>
    <manufacturerSrn>NZ-MF-000009327</manufacturerSrn>
    <authorisedRepresentativeName>BEO MedConsulting Berlin GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000006764</authorisedRepresentativeSrn>
    <riskClass>Sınıf I</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1257-2939-3F0_054</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:46:08.773Z</lastUpdated>
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    <tradeName>00199150019656</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
    <manufacturerSrn>US-PR-000013794</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BOX08576V1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
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    <deviceName></deviceName>
    <manufacturerName>Covidien llc</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode></emdnCode>
    <emdnDescription></emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>BOX08607V1</reference>
    <placedOnMarketCountry></placedOnMarketCountry>
    <lastUpdated>2026-07-07T03:46:08.728Z</lastUpdated>
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