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    <basicUdiDi>505601300CEIFEDIL3S</basicUdiDi>
    <tradeName>UltraCE IFE Diluent</tradeName>
    <deviceName>UltraCE IFE Diluent</deviceName>
    <manufacturerName>Helena Biosciences Europe</manufacturerName>
    <manufacturerSrn>GB-MF-000028365</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201050101</emdnCode>
    <emdnDescription>AUTOMATED ELECTROPHORESIS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V8150</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:22:32.652Z</lastUpdated>
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    <udiDi>05056013025818</udiDi>
    <basicUdiDi>505601300ULTCEURPREPXK</basicUdiDi>
    <tradeName>UltraCE Urine Prep</tradeName>
    <deviceName>UltraCE Urine Prep</deviceName>
    <manufacturerName>Helena Biosciences Europe</manufacturerName>
    <manufacturerSrn>GB-MF-000028365</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201050101</emdnCode>
    <emdnDescription>AUTOMATED ELECTROPHORESIS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:22:27.049Z</lastUpdated>
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    <udiDi>05056013025764</udiDi>
    <basicUdiDi>505601300ULTCEBUFS5Z</basicUdiDi>
    <tradeName>UltraCE Maintenance Buffer</tradeName>
    <deviceName>CE Maintenance and Storage Buffers</deviceName>
    <manufacturerName>Helena Biosciences Europe</manufacturerName>
    <manufacturerSrn>GB-MF-000028365</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201050101</emdnCode>
    <emdnDescription>AUTOMATED ELECTROPHORESIS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V8010</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:22:09.265Z</lastUpdated>
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    <udiDi>05056013025757</udiDi>
    <basicUdiDi>505601300V8ULTRACE3Z</basicUdiDi>
    <tradeName>V8 UltraCE</tradeName>
    <deviceName>V8 UltraCE</deviceName>
    <manufacturerName>Helena Biosciences Europe</manufacturerName>
    <manufacturerSrn>GB-MF-000028365</manufacturerSrn>
    <authorisedRepresentativeName>Advena Limited</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>MT-AR-000000234</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0201050101</emdnCode>
    <emdnDescription>AUTOMATED ELECTROPHORESIS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>V801</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-31T05:22:08.466Z</lastUpdated>
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    <udiDi>04987486039044</udiDi>
    <basicUdiDi>4987486BC0108223GL</basicUdiDi>
    <tradeName>The Lab 001 (CE-8810)</tradeName>
    <deviceName>The Lab 001 (CE-8810)</deviceName>
    <manufacturerName>ARKRAY Factory, Inc.</manufacturerName>
    <manufacturerSrn>JP-MF-000003008</manufacturerSrn>
    <authorisedRepresentativeName>ARKRAY Europe, B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000002056</authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020105010202</emdnCode>
    <emdnDescription>CAPILLARY ELECTROPHORESIS SYSTEMS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>108223</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-31T04:33:45.984Z</lastUpdated>
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  <row>
    <udiDi>03607360025819</udiDi>
    <basicUdiDi>3607362581BUDW</basicUdiDi>
    <tradeName>CAPI 3 BINS FOR USED REAGENT CUPS (5)</tradeName>
    <deviceName>CAPI 3 BINS FOR USED REAGENT CUPS (5)</deviceName>
    <manufacturerName>sebia</manufacturerName>
    <manufacturerSrn>FR-MF-000003520</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020105019085</emdnCode>
    <emdnDescription>VARIOUS ELECTROPHORESIS INTRUMENTS - CONSUMABLES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>2581</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:08:41.104Z</lastUpdated>
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  <row>
    <udiDi>03607360019498</udiDi>
    <basicUdiDi>3607361949BUF9</basicUdiDi>
    <tradeName>SCAN CONTROL FILM</tradeName>
    <deviceName>SCAN CONTROL FILM</deviceName>
    <manufacturerName>sebia</manufacturerName>
    <manufacturerSrn>FR-MF-000003520</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020105019099</emdnCode>
    <emdnDescription>VARIOUS ELECTROPHORESIS INTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1949</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:07:53.033Z</lastUpdated>
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  <row>
    <udiDi>03607360016527</udiDi>
    <basicUdiDi>3607361652BUDC</basicUdiDi>
    <tradeName>METAL WEIGHT 1.8KG</tradeName>
    <deviceName>METAL WEIGHT 1.8KG</deviceName>
    <manufacturerName>sebia</manufacturerName>
    <manufacturerSrn>FR-MF-000003520</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020105019099</emdnCode>
    <emdnDescription>VARIOUS ELECTROPHORESIS INTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1652</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:07:52.247Z</lastUpdated>
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  <row>
    <udiDi>03607360016510</udiDi>
    <basicUdiDi>3607361651BUD7</basicUdiDi>
    <tradeName>HYDRASYS 5 von WILLEBRAND MULTIMERS ACCESSORIES</tradeName>
    <deviceName>HYDRASYS 5 von WILLEBRAND MULTIMERS ACCESSORIES</deviceName>
    <manufacturerName>sebia</manufacturerName>
    <manufacturerSrn>FR-MF-000003520</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020105019099</emdnCode>
    <emdnDescription>VARIOUS ELECTROPHORESIS INTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1651</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:07:48.233Z</lastUpdated>
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  <row>
    <udiDi>03607360016503</udiDi>
    <basicUdiDi>3607361650BUD2</basicUdiDi>
    <tradeName>ANTISERA ADAPTER 9 POSITIONS FOR ASSIST</tradeName>
    <deviceName>ANTISERA ADAPTER 9 POSITIONS FOR ASSIST</deviceName>
    <manufacturerName>sebia</manufacturerName>
    <manufacturerSrn>FR-MF-000003520</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020105019099</emdnCode>
    <emdnDescription>VARIOUS ELECTROPHORESIS INTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1650</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:07:47.428Z</lastUpdated>
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    <udiDi>03607360016121</udiDi>
    <basicUdiDi>3607361612BUCG</basicUdiDi>
    <tradeName>MINICAP FLEX-PIERCING CENTERING RING FOR TUBES 11 mm (27)</tradeName>
    <deviceName>MINICAP FLEX-PIERCING CENTERING RING FOR TUBES 11 mm (27)</deviceName>
    <manufacturerName>sebia</manufacturerName>
    <manufacturerSrn>FR-MF-000003520</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020105019099</emdnCode>
    <emdnDescription>VARIOUS ELECTROPHORESIS INTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1612</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:07:46.633Z</lastUpdated>
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    <udiDi>03607360013915</udiDi>
    <basicUdiDi>3607361391BUD2</basicUdiDi>
    <tradeName>CAPILLARYS 3 &amp; MC SHUTDOWN RACK (1)</tradeName>
    <deviceName>CAPILLARYS 3 &amp; MC SHUTDOWN RACK (1)</deviceName>
    <manufacturerName>sebia</manufacturerName>
    <manufacturerSrn>FR-MF-000003520</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020105019099</emdnCode>
    <emdnDescription>VARIOUS ELECTROPHORESIS INTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1391</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:07:45.830Z</lastUpdated>
  </row>
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    <udiDi>03607360013892</udiDi>
    <basicUdiDi>3607361389BUE3</basicUdiDi>
    <tradeName>EXTERNAL ACCESSORIES FOR WASTE DISPOSAL OF CAPILLARYS 3</tradeName>
    <deviceName>EXTERNAL ACCESSORIES FOR WASTE DISPOSAL OF CAPILLARYS 3</deviceName>
    <manufacturerName>sebia</manufacturerName>
    <manufacturerSrn>FR-MF-000003520</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020105019099</emdnCode>
    <emdnDescription>VARIOUS ELECTROPHORESIS INTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1389</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:07:41.823Z</lastUpdated>
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  <row>
    <udiDi>03607360013830</udiDi>
    <basicUdiDi>3607361383BUD5</basicUdiDi>
    <tradeName>CAPILLARYS 3 &amp; MC SWITCH RACK FOR HbA1c (1)</tradeName>
    <deviceName>CAPILLARYS 3 &amp; MC SWITCH RACK FOR HbA1c (1)</deviceName>
    <manufacturerName>sebia</manufacturerName>
    <manufacturerSrn>FR-MF-000003520</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020105019099</emdnCode>
    <emdnDescription>VARIOUS ELECTROPHORESIS INTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1383</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:07:41.027Z</lastUpdated>
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    <udiDi>03607360013823</udiDi>
    <basicUdiDi>3607361382BUCY</basicUdiDi>
    <tradeName>CAPILLARYS 3 &amp; MC SWITCH RACK FOR IMMUNOTYPING (1)</tradeName>
    <deviceName>CAPILLARYS 3 &amp; MC SWITCH RACK FOR IMMUNOTYPING (1)</deviceName>
    <manufacturerName>sebia</manufacturerName>
    <manufacturerSrn>FR-MF-000003520</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020105019099</emdnCode>
    <emdnDescription>VARIOUS ELECTROPHORESIS INTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1382</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:07:40.221Z</lastUpdated>
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    <udiDi>03607360013816</udiDi>
    <basicUdiDi>3607361381BUCT</basicUdiDi>
    <tradeName>CAPILLARYS 3 &amp; MC SWITCH RACK FOR PROTEIN(E) 6 (1)</tradeName>
    <deviceName>CAPILLARYS 3 &amp; MC SWITCH RACK FOR PROTEIN(E) 6 (1)</deviceName>
    <manufacturerName>sebia</manufacturerName>
    <manufacturerSrn>FR-MF-000003520</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020105019099</emdnCode>
    <emdnDescription>VARIOUS ELECTROPHORESIS INTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1381</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:07:39.426Z</lastUpdated>
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    <udiDi>03607360013793</udiDi>
    <basicUdiDi>3607361379BUDU</basicUdiDi>
    <tradeName>CAPILLARYS 3 &amp; MC SWITCH RACK FOR IMMUNOTYPING URINE (1)</tradeName>
    <deviceName>CAPILLARYS 3 &amp; MC SWITCH RACK FOR IMMUNOTYPING URINE (1)</deviceName>
    <manufacturerName>sebia</manufacturerName>
    <manufacturerSrn>FR-MF-000003520</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020105019099</emdnCode>
    <emdnDescription>VARIOUS ELECTROPHORESIS INTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1379</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:07:35.422Z</lastUpdated>
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    <udiDi>03607360013786</udiDi>
    <basicUdiDi>3607361378BUDP</basicUdiDi>
    <tradeName>CAPILLARYS 3 &amp; MC SWITCH RACK FOR URINE (1)</tradeName>
    <deviceName>CAPILLARYS 3 &amp; MC SWITCH RACK FOR URINE (1)</deviceName>
    <manufacturerName>sebia</manufacturerName>
    <manufacturerSrn>FR-MF-000003520</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020105019099</emdnCode>
    <emdnDescription>VARIOUS ELECTROPHORESIS INTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1378</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:07:35.308Z</lastUpdated>
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    <udiDi>03607360013762</udiDi>
    <basicUdiDi>3607361376BUDD</basicUdiDi>
    <tradeName>CAPILLARYS 3 &amp; MC SWITCH RACK FOR CDT (1)</tradeName>
    <deviceName>CAPILLARYS 3 &amp; MC SWITCH RACK FOR CDT (1)</deviceName>
    <manufacturerName>sebia</manufacturerName>
    <manufacturerSrn>FR-MF-000003520</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020105019099</emdnCode>
    <emdnDescription>VARIOUS ELECTROPHORESIS INTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1376</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:07:34.130Z</lastUpdated>
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    <udiDi>03607360013731</udiDi>
    <basicUdiDi>3607361373BUCW</basicUdiDi>
    <tradeName>CAPILLARYS 3 &amp; MC SWITCH RACK FOR HEMOGLOBIN(E) (1)</tradeName>
    <deviceName>CAPILLARYS 3 &amp; MC SWITCH RACK FOR HEMOGLOBIN(E) (1)</deviceName>
    <manufacturerName>sebia</manufacturerName>
    <manufacturerSrn>FR-MF-000003520</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W020105019099</emdnCode>
    <emdnDescription>VARIOUS ELECTROPHORESIS INTRUMENTS - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1373</reference>
    <placedOnMarketCountry>France</placedOnMarketCountry>
    <lastUpdated>2026-07-30T18:07:33.023Z</lastUpdated>
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