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    <basicUdiDi>B-04049055003044</basicUdiDi>
    <tradeName>GenoType CVD VER 1.0</tradeName>
    <deviceName>GenoType CVD VER 1.0</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>33512</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:04:13.027Z</lastUpdated>
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    <udiDi>04049055001149</udiDi>
    <basicUdiDi>B-04049055001149</basicUdiDi>
    <tradeName>ThromboType®plus VER 3.0</tradeName>
    <deviceName>ThromboType®plus VER 3.0</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
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    <reference>341</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:03:53.005Z</lastUpdated>
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    <udiDi>04049055000456</udiDi>
    <basicUdiDi>B-04049055000456</basicUdiDi>
    <tradeName>GenoType IL-1 VER 1.0</tradeName>
    <deviceName>GenoType IL-1 VER 1.0</deviceName>
    <manufacturerName>Hain Lifescience GmbH</manufacturerName>
    <manufacturerSrn>DE-MF-000008606</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
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    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>5001</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-06T00:03:32.139Z</lastUpdated>
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    <udiDi>00863840000278</udiDi>
    <basicUdiDi>B-00863840000278</basicUdiDi>
    <tradeName>AmplideX SMA Plus Kit (50 rxn)</tradeName>
    <deviceName>AmplideX SMA Plus Kit</deviceName>
    <manufacturerName>Asuragen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011830</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00055</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:49:05.426Z</lastUpdated>
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    <udiDi>00850017493025</udiDi>
    <basicUdiDi>B-00850017493025</basicUdiDi>
    <tradeName>AmplideX SMA Plus Kit (100 rxn)</tradeName>
    <deviceName>AmplideX SMA Plus Kit</deviceName>
    <manufacturerName>Asuragen, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000011830</manufacturerSrn>
    <authorisedRepresentativeName>Emergo Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000116</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A00056</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-05T08:00:19.065Z</lastUpdated>
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    <udiDi>08906213930542</udiDi>
    <basicUdiDi>89080153043B1331KY</basicUdiDi>
    <tradeName>TRUPCR® MTHFR Mutation Detection Kit</tradeName>
    <deviceName>TRUPCR® MTHFR Mutation Detection Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B1331/C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:03:15.443Z</lastUpdated>
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    <udiDi>08906213930450</udiDi>
    <basicUdiDi>89080153043B247NM</basicUdiDi>
    <tradeName>TRUPCR® HLA B-27 Real-Time PCR Kit</tradeName>
    <deviceName>TRUPCR® HLA B-27 Real-Time PCR Kit</deviceName>
    <manufacturerName>3B BlackBio Dx Limited</manufacturerName>
    <manufacturerSrn>IN-MF-000023698</manufacturerSrn>
    <authorisedRepresentativeName>Wellkang Ltd</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>XI-AR-000001836</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>3B247/C</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-03T19:03:13.039Z</lastUpdated>
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    <udiDi>37350134361787</udiDi>
    <basicUdiDi>7350134361789C</basicUdiDi>
    <tradeName>37350134361787</tradeName>
    <deviceName>SPOT-it TREC &amp; SMN1 Screening Kit</deviceName>
    <manufacturerName>ImmunoIVD AB</manufacturerName>
    <manufacturerSrn>SE-MF-000034517</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>4-2020-TS</reference>
    <placedOnMarketCountry>Sweden</placedOnMarketCountry>
    <lastUpdated>2026-07-03T02:12:40.828Z</lastUpdated>
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    <udiDi>08720211482748</udiDi>
    <basicUdiDi>872021148P0445Q</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P044 NF2</tradeName>
    <deviceName>SALSA MLPA Probemix P044 NF2</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P044-100R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:44:41.874Z</lastUpdated>
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    <udiDi>08720211482731</udiDi>
    <basicUdiDi>872021148P0445Q</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P044 NF2</tradeName>
    <deviceName>SALSA MLPA Probemix P044 NF2</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P044-050R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:44:39.478Z</lastUpdated>
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    <udiDi>08720211482724</udiDi>
    <basicUdiDi>872021148P0445Q</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P044 NF2</tradeName>
    <deviceName>SALSA MLPA Probemix P044 NF2</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P044-025R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:44:38.273Z</lastUpdated>
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    <udiDi>08720211482663</udiDi>
    <basicUdiDi>872021148P1896K</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P189 CDKL5-FOXG1</tradeName>
    <deviceName>SALSA MLPA Probemix P189 CDKL5/ARX/FOXG1</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P189-100R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:44:37.086Z</lastUpdated>
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    <udiDi>08720211482656</udiDi>
    <basicUdiDi>872021148P1896K</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P189 CDKL5-FOXG1</tradeName>
    <deviceName>SALSA MLPA Probemix P189 CDKL5/ARX/FOXG1</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P189-050R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:44:35.888Z</lastUpdated>
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    <udiDi>08720211482632</udiDi>
    <basicUdiDi>872021148P1896K</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P189 CDKL5-FOXG1</tradeName>
    <deviceName>SALSA MLPA Probemix P189 CDKL5/ARX/FOXG1</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P189-025R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:44:29.878Z</lastUpdated>
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    <udiDi>08720211482441</udiDi>
    <basicUdiDi>872021148ME032ZH</basicUdiDi>
    <tradeName>SALSA MLPA Probemix ME032 UPD7-UPD14</tradeName>
    <deviceName>SALSA MLPA Probemix ME032 UPD7-UPD14</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME032-100R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:44:28.673Z</lastUpdated>
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    <udiDi>08720211482434</udiDi>
    <basicUdiDi>872021148ME032ZH</basicUdiDi>
    <tradeName>SALSA MLPA Probemix ME032 UPD7-UPD14</tradeName>
    <deviceName>SALSA MLPA Probemix ME032 UPD7-UPD14</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>ME032-050R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:44:27.493Z</lastUpdated>
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    <udiDi>08720211482359</udiDi>
    <basicUdiDi>872021148P4616C</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P461 STRC-CATSPER2-OTOA</tradeName>
    <deviceName>SALSA MLPA Probemix P461 STRC-CATSPER2-OTOA</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P461-100R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:44:20.262Z</lastUpdated>
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    <tradeName>SALSA MLPA Probemix P461 STRC-CATSPER2-OTOA</tradeName>
    <deviceName>SALSA MLPA Probemix P461 STRC-CATSPER2-OTOA</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P461-050R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:44:19.062Z</lastUpdated>
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    <tradeName>SALSA MLPA Probemix P461 STRC-CATSPER2-OTOA</tradeName>
    <deviceName>SALSA MLPA Probemix P461 STRC-CATSPER2-OTOA</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P461-025R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:44:17.861Z</lastUpdated>
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    <udiDi>08720211481871</udiDi>
    <basicUdiDi>872021148P2265Y</basicUdiDi>
    <tradeName>SALSA MLPA Probemix P226 SDH</tradeName>
    <deviceName>SALSA MLPA Probemix P226 SDH</deviceName>
    <manufacturerName>MRC Holland B.V.</manufacturerName>
    <manufacturerSrn>NL-MF-000000437</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0106010199</emdnCode>
    <emdnDescription>MONOGENETIC DISORDERS TESTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P226-100R</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-01T00:43:51.440Z</lastUpdated>
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