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    <tradeName>Artron Helicobacter pylori (HP) Antigen Test</tradeName>
    <deviceName>Helicobacter pylori (HP) Antigen Test</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02-11-422</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:52.655Z</lastUpdated>
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    <udiDi>00628347561178</udiDi>
    <basicUdiDi>B-00628347561178</basicUdiDi>
    <tradeName>Artron Helicobacter Pylori (HP) Antibody Test</tradeName>
    <deviceName>Helicobacter Pylori (HP) Antibody Test</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
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    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
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    <reference>A02-11-222</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:51.876Z</lastUpdated>
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    <udiDi>00628347561123</udiDi>
    <basicUdiDi>B-00628347561123</basicUdiDi>
    <tradeName>Artron One Step Treponema Pallidum (TP) Antibody Test</tradeName>
    <deviceName>Treponema Pallidum (TP) Antibody Test</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
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    <legislation>IVDD</legislation>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02-09-322</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:51.065Z</lastUpdated>
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    <udiDi>00628347561116</udiDi>
    <basicUdiDi>B-00628347561116</basicUdiDi>
    <tradeName>Artron One Step Treponema Pallidum (TP) Antibody Test</tradeName>
    <deviceName>Treponema Pallidum (TP) Antibody Test</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02-09-222</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:46.257Z</lastUpdated>
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    <udiDi>00628347561109</udiDi>
    <basicUdiDi>B-00628347561109</basicUdiDi>
    <tradeName>Artron One Step Treponema Pallidum (TP) Antibody Test</tradeName>
    <deviceName>Treponema Pallidum (TP) Antibody Test</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105090105</emdnCode>
    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>A02-09-213</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-04T14:22:45.549Z</lastUpdated>
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    <udiDi>00083059100518</udiDi>
    <basicUdiDi>B-00083059100518</basicUdiDi>
    <tradeName>Fortel® Ulcer (H. pylori) Screening Test</tradeName>
    <deviceName></deviceName>
    <manufacturerName>Biomerica, Inc.</manufacturerName>
    <manufacturerSrn>US-MF-000015772</manufacturerSrn>
    <authorisedRepresentativeName>MDSS GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000005430</authorisedRepresentativeSrn>
    <riskClass>IVD Kendi Kendine Test</riskClass>
    <legislation>UNKNOWN</legislation>
    <emdnCode>W0105090102</emdnCode>
    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1005-1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-07-04T06:06:22.249Z</lastUpdated>
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    <tradeName>LoopReagent</tradeName>
    <deviceName>LoopReagent</deviceName>
    <manufacturerName>Loop Diagnostics S.L.</manufacturerName>
    <manufacturerSrn>ES-MF-000047379</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf A</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>SL001R</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T12:14:53.393Z</lastUpdated>
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    <udiDi>08436610290883</udiDi>
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    <tradeName>VIRAPID® CLOSTRIDIUM DIFFICILE (GDH/TOX A/TOX B) Ag</tradeName>
    <deviceName>VIRAPID® CLOSTRIDIUM DIFFICILE (GDH/TOX A/TOX B) Ag</deviceName>
    <manufacturerName>Vircell, S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000004099</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090106</emdnCode>
    <emdnDescription>CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VRC005</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:58:14.223Z</lastUpdated>
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    <udiDi>08436610290876</udiDi>
    <basicUdiDi>843661029VRC00401PZ</basicUdiDi>
    <tradeName>VIRAPID® CLOSTRIDIUM DIFFICILE (GDH) Ag</tradeName>
    <deviceName>VIRAPID® CLOSTRIDIUM DIFFICILE (GDH) Ag</deviceName>
    <manufacturerName>Vircell, S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000004099</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090106</emdnCode>
    <emdnDescription>CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>VRC004</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:58:12.749Z</lastUpdated>
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    <udiDi>08436610290869</udiDi>
    <basicUdiDi>843661029VRC00301PU</basicUdiDi>
    <tradeName>VIRAPID® STREPTOCOCCUS GROUP A Ag</tradeName>
    <deviceName>VIRAPID® STREPTOCOCCUS GROUP A Ag</deviceName>
    <manufacturerName>Vircell, S.L</manufacturerName>
    <manufacturerSrn>ES-MF-000004099</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>VRC003</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T11:58:10.216Z</lastUpdated>
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    <udiDi>08429577004679</udiDi>
    <basicUdiDi>84295779231XW</basicUdiDi>
    <tradeName>Simple H.pyl-Tf</tradeName>
    <deviceName>SIMPLE H.pyl-Tf</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</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>9.231.020.21.000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:18:01.623Z</lastUpdated>
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    <udiDi>08429577004143</udiDi>
    <basicUdiDi>84295779134XX</basicUdiDi>
    <tradeName>Simple / Stick Strep A</tradeName>
    <deviceName>Simple Strep A / Stick Strep A</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
    <riskClass>IVD Sınıf B</riskClass>
    <legislation>IVDR 2017/746</legislation>
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    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.134.040.00.000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:17:57.620Z</lastUpdated>
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    <basicUdiDi>84295779065Y5</basicUdiDi>
    <tradeName>Simple GDH-Toxins</tradeName>
    <deviceName>SIMPLE GDH-Toxins</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
    <authorisedRepresentativeSrn></authorisedRepresentativeSrn>
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    <legislation>IVDR 2017/746</legislation>
    <emdnCode>W0105090106</emdnCode>
    <emdnDescription>CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.065.020.20.000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:17:42.439Z</lastUpdated>
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    <udiDi>08429577002828</udiDi>
    <basicUdiDi>84295779045XX</basicUdiDi>
    <tradeName>SIMPLE GDH / STICK GDH</tradeName>
    <deviceName>SIMPLE GDH / STICK GDH</deviceName>
    <manufacturerName>OPERON, S.A.</manufacturerName>
    <manufacturerSrn>ES-MF-000004790</manufacturerSrn>
    <authorisedRepresentativeName></authorisedRepresentativeName>
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    <emdnDescription>CLOST. DIFF. INCL GDH AND/OR TOXIN A AND B - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>9.045.020.00.000</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-07-03T10:17:25.654Z</lastUpdated>
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    <basicUdiDi>802816920BW01050503013Y</basicUdiDi>
    <tradeName>Helori Urease</tradeName>
    <deviceName>Helori Urease</deviceName>
    <manufacturerName>Eurospital Spa</manufacturerName>
    <manufacturerSrn>IT-MF-000028468</manufacturerSrn>
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    <emdnDescription>H. PYLORI - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1693</reference>
    <placedOnMarketCountry>Italy</placedOnMarketCountry>
    <lastUpdated>2026-07-03T04:39:05.787Z</lastUpdated>
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    <tradeName>GenSure Strep A Rapid Test</tradeName>
    <deviceName>Strep A Rapid Test</deviceName>
    <manufacturerName>GenSure Biotech Inc.</manufacturerName>
    <manufacturerSrn>CN-MF-000028354</manufacturerSrn>
    <authorisedRepresentativeName>RIOMAVIX SOCIEDAD LIMITADA</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000001202</authorisedRepresentativeSrn>
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    <emdnDescription>STREP. A - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>P2019C01</reference>
    <placedOnMarketCountry>Cyprus</placedOnMarketCountry>
    <lastUpdated>2026-07-02T19:10:19.743Z</lastUpdated>
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    <tradeName>H.Pylori Antibody Rapid Test</tradeName>
    <deviceName>H.Pylori Antibody Rapid Test</deviceName>
    <manufacturerName>Hangzhou Tongzhou Biotechnology Co., Ltd.</manufacturerName>
    <manufacturerSrn>CN-MF-000038774</manufacturerSrn>
    <authorisedRepresentativeName>CMC Medical Devices &amp; Drugs SL</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000000293</authorisedRepresentativeSrn>
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    <deviceStatus>Piyasada</deviceStatus>
    <reference>I021-N4002T-25</reference>
    <placedOnMarketCountry>Ireland</placedOnMarketCountry>
    <lastUpdated>2026-07-02T15:17:28.102Z</lastUpdated>
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    <tradeName>Acmex Treponema Pallidum (TP) Antibody Test</tradeName>
    <deviceName>Syphilis Test</deviceName>
    <manufacturerName>Artron Laboratories Inc.</manufacturerName>
    <manufacturerSrn>CA-MF-000028974</manufacturerSrn>
    <authorisedRepresentativeName>MedNet EC-REP GmbH</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>DE-AR-000000002</authorisedRepresentativeSrn>
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    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>AM02-09-322P</reference>
    <placedOnMarketCountry>Romania</placedOnMarketCountry>
    <lastUpdated>2026-07-02T05:32:27.826Z</lastUpdated>
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    <deviceName>RPR Carbon bez kontroli 100 ozn.</deviceName>
    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
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    <emdnDescription>SYPHILIS - RT &amp; POC</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>1-916-1001</reference>
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    <manufacturerName>BioMaxima Spółka Akcyjna</manufacturerName>
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    <emdnCode>W0105090199</emdnCode>
    <emdnDescription>BACTERIOLOGY - RT &amp; POC - OTHER</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
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    <lastUpdated>2026-07-02T02:27:31.271Z</lastUpdated>
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