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    <udiDi>05944759080133</udiDi>
    <basicUdiDi>5944759080VTFOB25FECPB62B</basicUdiDi>
    <tradeName>FOB RAPID TEST CASSETTE (FECES), POSITIVE CONTROL SWAB INCLUDED</tradeName>
    <deviceName>FOB RAPID TEST CASSETTE (FECES), POSITIVE CONTROL SWAB INCLUDED</deviceName>
    <manufacturerName>VitroBioChem SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000010877</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-FOB-25</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:25:45.274Z</lastUpdated>
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    <udiDi>05944759080126</udiDi>
    <basicUdiDi>5944759080VTCDABGDH25B6X8</basicUdiDi>
    <tradeName>Clostridium difficile GDH+Toxin A+Toxin B Combo, Rapid Test Cassette (Feces), positive controls included Test rapid determinare Clostridium difficile GDH+Toxina A+Toxina B, caseta COMBO (materii fecale) cu controale pozitive swab incluse</tradeName>
    <deviceName>Clostridium difficile GDH+Toxin A+Toxin B Combo, Rapid Test Cassette (Feces), positive controls included Test rapid determinare Clostridium difficile GDH+Toxina A+Toxina B, caseta COMBO (materii fecale) cu controale pozitive swab incluse</deviceName>
    <manufacturerName>VitroBioChem SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000010877</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105011803</emdnCode>
    <emdnDescription>C.DIFFICILE GDH AND TOXIN A/B COMBINED DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-CDABGDH-25</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:25:44.476Z</lastUpdated>
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    <udiDi>05944759080119</udiDi>
    <basicUdiDi>5944759080VTRSVA25STNB68G</basicUdiDi>
    <tradeName>RSV Ag + Adenovirus Resp. Ag COMBO rapid test cassette (Swab) positive controls included Test rapid determinare RSV Ag + Adenovirus Resp. Ag COMBO, caseta (Swab) cu controale pozitive incluse</tradeName>
    <deviceName>RSV Ag + Adenovirus Resp. Ag COMBO rapid test cassette (Swab) positive controls included Test rapid determinare RSV Ag + Adenovirus Resp. Ag COMBO, caseta (Swab) cu controale pozitive incluse</deviceName>
    <manufacturerName>VitroBioChem SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000010877</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-RSVA-25</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:25:43.674Z</lastUpdated>
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  <row>
    <udiDi>05944759080096</udiDi>
    <basicUdiDi>5944759080VTSTA25STSMB6Y7</basicUdiDi>
    <tradeName>Rapid Test Cassette Strep A (Throat Swab) positive and negative controls included Test rapid Strep A (exudat), caseta, control pozitiv si control negativ incluse</tradeName>
    <deviceName>Rapid Test Cassette Strep A (Throat Swab) positive and negative controls included Test rapid Strep A (exudat), caseta, control pozitiv si control negativ incluse</deviceName>
    <manufacturerName>VitroBioChem SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000010877</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090103</emdnCode>
    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-STA-25</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:25:42.873Z</lastUpdated>
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    <udiDi>05944759080089</udiDi>
    <basicUdiDi>5944759080VTRACG25FECB64H</basicUdiDi>
    <tradeName>Rotavirus Ag and Adenovirus Ag (Feces) COMBO Rapid Test Cassette Test rapid Rotavirus Ag si Adenovirus Ag (materii fecale) COMBO caseta</tradeName>
    <deviceName>Rotavirus Ag and Adenovirus Ag (Feces) COMBO Rapid Test Cassette Test rapid Rotavirus Ag si Adenovirus Ag (materii fecale) COMBO caseta</deviceName>
    <manufacturerName>VitroBioChem SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000010877</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-RAC-25</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:25:38.868Z</lastUpdated>
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    <udiDi>05944759080072</udiDi>
    <basicUdiDi>5944759080VTHAVM25SPCB6JW</basicUdiDi>
    <tradeName>HAV IgM Rapid Test Cassette (Serum/ Plasma) Test Rapid HAV IgM (ser/plasma), caseta</tradeName>
    <deviceName>HAV IgM Rapid Test Cassette (Serum/ Plasma) Test Rapid HAV IgM (ser/plasma), caseta</deviceName>
    <manufacturerName>VitroBioChem SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000010877</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W01021699</emdnCode>
    <emdnDescription>RAPID TESTS &amp; POINT OF CARE - IMMUNOCHEMISTRY - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-HAVM-25</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:25:38.071Z</lastUpdated>
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    <udiDi>05944759080065</udiDi>
    <basicUdiDi>5944759080VTGIAG25FECB6XK</basicUdiDi>
    <tradeName>Giardia lamblia Ag (Feces)Rapid Test cassette Test rapid Giardia lamblia Ag (din materii fecale) caseta</tradeName>
    <deviceName>Giardia lamblia Ag (Feces)Rapid Test cassette Test rapid Giardia lamblia Ag (din materii fecale) caseta</deviceName>
    <manufacturerName>VitroBioChem SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000010877</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-GIA-25</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:25:37.275Z</lastUpdated>
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    <udiDi>05944759080058</udiDi>
    <basicUdiDi>5944759080VTSYP25WBSPC3BE</basicUdiDi>
    <tradeName>Syphilis (Whole blood /Serum /Plasma) Rapid Test Cassette Test rapid Sifilis (sange total/ser/plasma) caseta</tradeName>
    <deviceName>Syphilis (Whole blood /Serum /Plasma) Rapid Test Cassette Test rapid Sifilis (sange total/ser/plasma) caseta</deviceName>
    <manufacturerName>VitroBioChem SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000010877</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf C</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-SYP-25</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:25:36.463Z</lastUpdated>
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    <udiDi>05944759080041</udiDi>
    <basicUdiDi>5944759080VTMLD1225USB6V3</basicUdiDi>
    <tradeName>Multi-Line 12 Drugs Rapid Test Cassette (urine) TEST RAPID MULTIDROG 12 PARAMETRI (DIN URINA) CASETA</tradeName>
    <deviceName>Multi-Line 12 Drugs Rapid Test Cassette (urine) TEST RAPID MULTIDROG 12 PARAMETRI (DIN URINA) CASETA</deviceName>
    <manufacturerName>VitroBioChem SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000010877</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-MLD12-25</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:25:32.499Z</lastUpdated>
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    <udiDi>05944759080034</udiDi>
    <basicUdiDi>5944759080VTENTG25FECB6FW</basicUdiDi>
    <tradeName>Enterovirus Ag (feces) cassette Test rapid Enterovirus Ag (din materii fecale) caseta</tradeName>
    <deviceName>Enterovirus Ag (feces) cassette Test rapid Enterovirus Ag (din materii fecale) caseta</deviceName>
    <manufacturerName>VitroBioChem SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000010877</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0101060399</emdnCode>
    <emdnDescription>FAECES TESTS - RAPID TESTS AND "POINT OF CARE" - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-ENT-25</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:25:31.672Z</lastUpdated>
  </row>
  <row>
    <udiDi>05944759080027</udiDi>
    <basicUdiDi>5944759080VTMLD1825USB6Y9</basicUdiDi>
    <tradeName>Multi-Line 18 Drugs (urine) Test Cassette TEST RAPID MULTIDROG 18 PARAMETRI (DIN URINA) CASETA</tradeName>
    <deviceName>Multi-Line 18 Drugs (urine) Test Cassette TEST RAPID MULTIDROG 18 PARAMETRI (DIN URINA) CASETA</deviceName>
    <manufacturerName>VitroBioChem SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000010877</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0102160511</emdnCode>
    <emdnDescription>MULTIPLE DRUGS OF ABUSE/TOXICOLOGY RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-MLD18-25</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:25:31.051Z</lastUpdated>
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    <udiDi>05944759080010</udiDi>
    <basicUdiDi>5944759080VTHPB25SPROB6HC</basicUdiDi>
    <tradeName>HELICOBACTER PYLORI AB RAPID TEST CASSETTE (SERUM/PLASMA)</tradeName>
    <deviceName>HELICOBACTER PYLORI AB RAPID TEST CASSETTE (SERUM/PLASMA)</deviceName>
    <manufacturerName>VitroBioChem SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000010877</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-HPBSP-25</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:25:30.962Z</lastUpdated>
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    <udiDi>05944759080003</udiDi>
    <basicUdiDi>5944759080VTHPG25STO1B6H5</basicUdiDi>
    <tradeName>TEST RAPID H. PYLORI ANTIGEN CASETA(SCAUN)</tradeName>
    <deviceName>HELICOBACTER PYLORI AG RAPID TEST CASSETTE (FECES)</deviceName>
    <manufacturerName>VitroBioChem SRL</manufacturerName>
    <manufacturerSrn>RO-MF-000010877</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105010401</emdnCode>
    <emdnDescription>H. PYLORI ANTIGEN DETECTION</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VT-HPG-25</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-31T13:25:23.669Z</lastUpdated>
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