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    <tradeName>VACS II 20.0 x 60</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0050</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:39:14.839Z</lastUpdated>
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    <udiDi>04044508109373</udiDi>
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    <tradeName>VACS II 20.0 x 50</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:39:14.054Z</lastUpdated>
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    <tradeName>VACS II 20.0 x 40</tradeName>
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    <manufacturerName>OSYPKA GmbH</manufacturerName>
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    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-05T20:39:13.231Z</lastUpdated>
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    <tradeName>VACS II 20.0 x 30</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
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    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:39:12.441Z</lastUpdated>
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    <udiDi>04044508109342</udiDi>
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    <tradeName>VACS II 18.0 x 60</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0046</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:39:08.434Z</lastUpdated>
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    <udiDi>04044508109335</udiDi>
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    <tradeName>VACS II 18.0 x 50</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0045</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:39:07.632Z</lastUpdated>
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    <udiDi>04044508109328</udiDi>
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    <tradeName>VACS II 18.0 x 40</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0044</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:39:06.830Z</lastUpdated>
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    <udiDi>04044508109311</udiDi>
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    <tradeName>VACS II 18.0 x 30</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0043</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:39:06.038Z</lastUpdated>
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    <udiDi>04044508109304</udiDi>
    <basicUdiDi>B-04044508109304</basicUdiDi>
    <tradeName>VACS II 17.0 x 60</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0042</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:39:02.023Z</lastUpdated>
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    <udiDi>04044508109281</udiDi>
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    <tradeName>VACS II 17.0 x 40</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0040</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:39:01.225Z</lastUpdated>
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    <udiDi>04044508109267</udiDi>
    <basicUdiDi>B-04044508109267</basicUdiDi>
    <tradeName>VACS II 16.0 x 60</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0038</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:39:00.424Z</lastUpdated>
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    <udiDi>04044508109250</udiDi>
    <basicUdiDi>B-04044508109250</basicUdiDi>
    <tradeName>VACS II 16.0 x 50</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0037</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:38:59.642Z</lastUpdated>
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    <udiDi>04044508109243</udiDi>
    <basicUdiDi>B-04044508109243</basicUdiDi>
    <tradeName>VACS II 16.0 x 40</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0036</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:38:55.644Z</lastUpdated>
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    <udiDi>04044508109236</udiDi>
    <basicUdiDi>B-04044508109236</basicUdiDi>
    <tradeName>VACS II 16.0 x 30</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0035</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:38:54.824Z</lastUpdated>
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    <udiDi>04044508109205</udiDi>
    <basicUdiDi>B-04044508109205</basicUdiDi>
    <tradeName>VACS II 15.0 x 40</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0032</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:38:54.036Z</lastUpdated>
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    <udiDi>04044508109182</udiDi>
    <basicUdiDi>B-04044508109182</basicUdiDi>
    <tradeName>VACS II 14.0 x 60</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
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    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:38:53.238Z</lastUpdated>
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    <udiDi>04044508109175</udiDi>
    <basicUdiDi>B-04044508109175</basicUdiDi>
    <tradeName>VACS II 14.0 x 50</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0029</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:38:49.224Z</lastUpdated>
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    <udiDi>04044508109168</udiDi>
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    <tradeName>VACS II 14.0 x 40</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
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    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0028</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:38:48.420Z</lastUpdated>
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    <udiDi>04044508109151</udiDi>
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    <tradeName>VACS II 14.0 x 30</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0027</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:38:47.621Z</lastUpdated>
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    <udiDi>04044508109144</udiDi>
    <basicUdiDi>B-04044508109144</basicUdiDi>
    <tradeName>VACS II 12.0 x 60</tradeName>
    <deviceName></deviceName>
    <manufacturerName>OSYPKA GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000005610</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>Sınıf III</riskClass>
    <legislation>MDD</legislation>
    <emdnCode>C019014</emdnCode>
    <emdnDescription>CARDIAC VALVULOPLASTY CATHETERS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>YA0026</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-05T20:38:46.830Z</lastUpdated>
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