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    <basicUdiDi>B-84365942142884</basicUdiDi>
    <tradeName>biotical FOB + Transferrin  Card (+PC +NC)</tradeName>
    <deviceName>biotical FOB + Transferrin  Card (+PC +NC)</deviceName>
    <manufacturerName>BIOTICAL HEALTH S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000018831</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTB25FTCN</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:02:10.215Z</lastUpdated>
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    <udiDi>84365942142716</udiDi>
    <basicUdiDi>B-84365942142716</basicUdiDi>
    <tradeName>biotical FOB + Transferrin  Card (+PC)</tradeName>
    <deviceName>biotical FOB + Transferrin  Card (+PC)</deviceName>
    <manufacturerName>BIOTICAL HEALTH S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000018831</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTB25FTC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:02:06.215Z</lastUpdated>
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    <udiDi>84365942142648</udiDi>
    <basicUdiDi>B-84365942142648</basicUdiDi>
    <tradeName>biotical FOB + Transferrin  Card</tradeName>
    <deviceName>biotical FOB + Transferrin  Card</deviceName>
    <manufacturerName>BIOTICAL HEALTH S.L.U</manufacturerName>
    <manufacturerSrn>ES-MF-000018831</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTB25FT</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:02:05.416Z</lastUpdated>
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    <udiDi>D-811068PK</udiDi>
    <basicUdiDi>B-811068PK</basicUdiDi>
    <tradeName>D-811068PK</tradeName>
    <deviceName>Vitamin B12 Rapid Test</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>811068</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:58:16.575Z</lastUpdated>
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    <udiDi>D-811031NU</udiDi>
    <basicUdiDi>B-811031NU</basicUdiDi>
    <tradeName>D-811031NU</tradeName>
    <deviceName>FA/VB12/Fer Combined Detect</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>811031</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:57:22.643Z</lastUpdated>
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    <udiDi>D-811030NS</udiDi>
    <basicUdiDi>B-811030NS</basicUdiDi>
    <tradeName>D-811030NS</tradeName>
    <deviceName>FA/VB12/Fer Combined Test</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>811030</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:57:18.645Z</lastUpdated>
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    <udiDi>D-811029P9</udiDi>
    <basicUdiDi>B-811029P9</basicUdiDi>
    <tradeName>D-811029P9</tradeName>
    <deviceName>VA/25-OH-VD Combined Detect</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>811029</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:57:14.639Z</lastUpdated>
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    <udiDi>D-811028P7</udiDi>
    <basicUdiDi>B-811028P7</basicUdiDi>
    <tradeName>D-811028P7</tradeName>
    <deviceName>VA/25-OH-VD Combined Test</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>811028</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:57:13.840Z</lastUpdated>
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    <udiDi>D-740000NW</udiDi>
    <basicUdiDi>B-740000NW</basicUdiDi>
    <tradeName>ZuhauseTEST Fructwasser</tradeName>
    <deviceName>ZuhauseTEST Fructwasser</deviceName>
    <manufacturerName>PRIMA Lab SA</manufacturerName>
    <manufacturerSrn>CH-MF-000034473</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>740000</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:07:40.558Z</lastUpdated>
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    <udiDi>D-410250MF</udiDi>
    <basicUdiDi>B-410250MF</basicUdiDi>
    <tradeName>GlutenCHECK</tradeName>
    <deviceName>GlutenCHECK [DE/EN/FR/NL]</deviceName>
    <manufacturerName>NanoRepro AG</manufacturerName>
    <manufacturerSrn>DE-MF-000023735</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>410250</reference>
    <placedOnMarketCountry>Netherlands</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:08:16.098Z</lastUpdated>
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    <udiDi>D-400650MQ</udiDi>
    <basicUdiDi>B-400650MQ</basicUdiDi>
    <tradeName>Co-TEST KELIAKIATESTI</tradeName>
    <deviceName>Co-Test KELIAKIATESTI</deviceName>
    <manufacturerName>NanoRepro AG</manufacturerName>
    <manufacturerSrn>DE-MF-000023735</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>400650</reference>
    <placedOnMarketCountry>Finland</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:05:09.117Z</lastUpdated>
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    <udiDi>D-400660MT</udiDi>
    <basicUdiDi>B-400660MT</basicUdiDi>
    <tradeName>GlutenCHECK</tradeName>
    <deviceName>GlutenCHECK  [BG/EN]</deviceName>
    <manufacturerName>NanoRepro AG</manufacturerName>
    <manufacturerSrn>DE-MF-000023735</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>400660</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:05:04.307Z</lastUpdated>
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    <udiDi>D-400640MM</udiDi>
    <basicUdiDi>B-400640MM</basicUdiDi>
    <tradeName>GlutenCHECK [TR/EN]</tradeName>
    <deviceName>GlutenCHECK</deviceName>
    <manufacturerName>NanoRepro AG</manufacturerName>
    <manufacturerSrn>DE-MF-000023735</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>400640</reference>
    <placedOnMarketCountry>Türkiye</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:05:03.518Z</lastUpdated>
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    <udiDi>D-400630MJ</udiDi>
    <basicUdiDi>B-400630MJ</basicUdiDi>
    <tradeName>GlutenCHECK</tradeName>
    <deviceName>GlutenCHECK</deviceName>
    <manufacturerName>NanoRepro AG</manufacturerName>
    <manufacturerSrn>DE-MF-000023735</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>400630</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:05:02.848Z</lastUpdated>
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    <udiDi>D-400620MF</udiDi>
    <basicUdiDi>B-400620MF</basicUdiDi>
    <tradeName>GlutenCHECK</tradeName>
    <deviceName>GlutenCHECK</deviceName>
    <manufacturerName>NanoRepro AG</manufacturerName>
    <manufacturerSrn>DE-MF-000023735</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>400620</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:04:47.443Z</lastUpdated>
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    <udiDi>D-400610MC</udiDi>
    <basicUdiDi>B-400610MC</basicUdiDi>
    <tradeName>RapiChek GlutenTEST</tradeName>
    <deviceName>RapiChek GlutenTEST</deviceName>
    <manufacturerName>NanoRepro AG</manufacturerName>
    <manufacturerSrn>DE-MF-000023735</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>400610</reference>
    <placedOnMarketCountry>Hungary</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:04:46.640Z</lastUpdated>
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    <udiDi>D-400600M9</udiDi>
    <basicUdiDi>B-400600M9</basicUdiDi>
    <tradeName>GlutenCHECK</tradeName>
    <deviceName>GlutenCHECK [PT/EN]</deviceName>
    <manufacturerName>NanoRepro AG</manufacturerName>
    <manufacturerSrn>DE-MF-000023735</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>400600</reference>
    <placedOnMarketCountry>Portugal</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:04:45.844Z</lastUpdated>
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    <udiDi>D-400500M4</udiDi>
    <basicUdiDi>B-400500M4</basicUdiDi>
    <tradeName>Screen Test Celiachia</tradeName>
    <deviceName>Screen Test Celiachia (IT/EN/ES/PL/FR/HU/PT/RO)</deviceName>
    <manufacturerName>NanoRepro AG</manufacturerName>
    <manufacturerSrn>DE-MF-000023735</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>400500</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:04:41.723Z</lastUpdated>
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    <udiDi>D-400490MS</udiDi>
    <basicUdiDi>B-400490MS</basicUdiDi>
    <tradeName>GlutenCHECK</tradeName>
    <deviceName>GlutenCHECK [SLO]</deviceName>
    <manufacturerName>NanoRepro AG</manufacturerName>
    <manufacturerSrn>DE-MF-000023735</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>400490</reference>
    <placedOnMarketCountry>Slovenia</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:04:40.233Z</lastUpdated>
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    <udiDi>D-400480MP</udiDi>
    <basicUdiDi>B-400480MP</basicUdiDi>
    <tradeName>GlutenCHECK</tradeName>
    <deviceName>GlutenCHECK</deviceName>
    <manufacturerName>NanoRepro AG</manufacturerName>
    <manufacturerSrn>DE-MF-000023735</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>400480</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-11T16:04:39.431Z</lastUpdated>
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