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    <tradeName>biotical Norovirus Gen I + II Card</tradeName>
    <deviceName>biotical Norovirus Gen I + II 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTB25NV</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:03:14.303Z</lastUpdated>
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    <udiDi>84365942145854</udiDi>
    <basicUdiDi>B-84365942145854</basicUdiDi>
    <tradeName>biotical Astrovirus Positive control (30u)</tradeName>
    <deviceName>biotical Astrovirus Positive control (30u)</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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>CPRT30AT</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:03:09.498Z</lastUpdated>
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    <udiDi>84365942145786</udiDi>
    <basicUdiDi>B-84365942145786</basicUdiDi>
    <tradeName>biotical Astrovirus Card (+PC +NC)</tradeName>
    <deviceName>biotical Astrovirus 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTB25ATCN</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:03:08.691Z</lastUpdated>
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    <udiDi>84365942145610</udiDi>
    <basicUdiDi>B-84365942145610</basicUdiDi>
    <tradeName>biotical Astrovirus Card (+PC)</tradeName>
    <deviceName>biotical Astrovirus 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTB25ATC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:03:08.142Z</lastUpdated>
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    <udiDi>84365942145540</udiDi>
    <basicUdiDi>B-84365942145540</basicUdiDi>
    <tradeName>biotical Astrovirus Card</tradeName>
    <deviceName>biotical Astrovirus 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTB25AT</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:03:03.906Z</lastUpdated>
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    <udiDi>84365942145472</udiDi>
    <basicUdiDi>B-84365942145472</basicUdiDi>
    <tradeName>biotical Rotavirus + Adenovirus  Card (+PC +NC)</tradeName>
    <deviceName>biotical Rotavirus + Adenovirus  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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTB25RACN</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:03:03.090Z</lastUpdated>
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    <udiDi>84365942145304</udiDi>
    <basicUdiDi>B-84365942145304</basicUdiDi>
    <tradeName>biotical Rotavirus + Adenovirus  Card (+PC)</tradeName>
    <deviceName>biotical Rotavirus + Adenovirus  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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTB25RAC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:03:02.290Z</lastUpdated>
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    <udiDi>84365942145236</udiDi>
    <basicUdiDi>B-84365942145236</basicUdiDi>
    <tradeName>biotical Rotavirus + Adenovirus  Card</tradeName>
    <deviceName>biotical Rotavirus + Adenovirus  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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTB25RA</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:03:01.490Z</lastUpdated>
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    <udiDi>84365942144932</udiDi>
    <basicUdiDi>B-84365942144932</basicUdiDi>
    <tradeName>biotical Adeno Intestinal Card (+PC +NC)</tradeName>
    <deviceName>biotical Adeno Intestinal 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTB25ADCN</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:02:55.888Z</lastUpdated>
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  <row>
    <udiDi>84365942144864</udiDi>
    <basicUdiDi>B-84365942144864</basicUdiDi>
    <tradeName>biotical Adeno Intestinal Card (+PC)</tradeName>
    <deviceName>biotical Adeno Intestinal 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTB25ADC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:02:55.086Z</lastUpdated>
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    <udiDi>84365942144482</udiDi>
    <basicUdiDi>B-84365942144482</basicUdiDi>
    <tradeName>biotical Rotavirus Card (+PC +NC)</tradeName>
    <deviceName>biotical Rotavirus 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTB25RCN</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:02:50.312Z</lastUpdated>
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    <udiDi>84365942144796</udiDi>
    <basicUdiDi>B-84365942144796</basicUdiDi>
    <tradeName>biotical Adeno Intestinal Card</tradeName>
    <deviceName>biotical Adeno Intestinal 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTB25AD</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:02:49.491Z</lastUpdated>
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    <udiDi>84365942144314</udiDi>
    <basicUdiDi>B-84365942144314</basicUdiDi>
    <tradeName>biotical Rotavirus Card (+PC)</tradeName>
    <deviceName>biotical Rotavirus 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTB25RC</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:02:31.829Z</lastUpdated>
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  <row>
    <udiDi>84365942144246</udiDi>
    <basicUdiDi>B-84365942144246</basicUdiDi>
    <tradeName>biotical Rotavirus Card</tradeName>
    <deviceName>biotical Rotavirus 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>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>RTB25R</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:02:31.038Z</lastUpdated>
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    <udiDi>D-81649002AIAH501DC9SA</udiDi>
    <basicUdiDi>B-81649002AIAH501DC9SA</basicUdiDi>
    <tradeName>D-81649002AIAH501DC9SA</tradeName>
    <deviceName>Influenza A Virus and H5 Subtype Fluorescence PCR Kit (Lyophilized)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AIAH501D-AHG48E; AIAH501D-AHG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T07:00:21.539Z</lastUpdated>
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    <udiDi>D-81649002AFAB03D6VFC</udiDi>
    <basicUdiDi>B-81649002AFAB03D6VFC</basicUdiDi>
    <tradeName>D-81649002AFAB03D6VFC</tradeName>
    <deviceName>Influenza A/B Virus Fluorescence PCR Kit (Lyophilized)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFAB03D-AHG48E; AFAB03D-AHG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:59:43.076Z</lastUpdated>
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    <udiDi>D-81649002AFAB038S9K</udiDi>
    <basicUdiDi>B-81649002AFAB038S9K</basicUdiDi>
    <tradeName>D-81649002AFAB038S9K</tradeName>
    <deviceName>Influenza A/B Virus Detection Kit (Fluorescence PCR)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFAB03-AHG48E; AFAB03-AHG96E; AFAB03D-AHG48E; AFAB03D-AHG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:59:42.276Z</lastUpdated>
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    <udiDi>D-81649002AFAB018N8X</udiDi>
    <basicUdiDi>B-81649002AFAB018N8X</basicUdiDi>
    <tradeName>D-81649002AFAB018N8X</tradeName>
    <deviceName>Influenza A/B  Detection Kit (Direct Fluorescence PCR)</deviceName>
    <manufacturerName>Healgen Scientific Limited Liability Company</manufacturerName>
    <manufacturerSrn>US-MF-000018839</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099004</emdnCode>
    <emdnDescription>INFLUENZA A AND /OR B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AFAB01-AHG48E; AFAB01-AHG96E</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:59:41.477Z</lastUpdated>
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    <udiDi>D-808128-1B8</udiDi>
    <basicUdiDi>B-808128-1B8</basicUdiDi>
    <tradeName>D-808128-1B8</tradeName>
    <deviceName>Rotavirus &amp; Adenovirus Rapid Test</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808128-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:54:27.364Z</lastUpdated>
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    <udiDi>D-808126-1AW</udiDi>
    <basicUdiDi>B-808126-1AW</basicUdiDi>
    <tradeName>D-808126-1AW</tradeName>
    <deviceName>Adenovirus Rapid Test</deviceName>
    <manufacturerName>Shenzhen Kang Sheng Bao Bio-Technology Co.,Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000024153</manufacturerSrn>
    <authorisedRepresentativeName>QbD RepS BV</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>BE-AR-000000040</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105099099</emdnCode>
    <emdnDescription>VIROLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>808126-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-12T06:54:25.761Z</lastUpdated>
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