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    <basicUdiDi>B-06970895476126</basicUdiDi>
    <tradeName>06970895476126</tradeName>
    <deviceName>Human Respiratory Virus Detection Kit (Fluorescent Probe-Based Real-Time PCR Assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R231T050B0C0</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:57:06.584Z</lastUpdated>
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    <udiDi>06970895476119</udiDi>
    <basicUdiDi>B-06970895476119</basicUdiDi>
    <tradeName>06970895476119</tradeName>
    <deviceName>Human Respiratory Virus Detection Kit (Fluorescent Probe-Based Real-Time PCR Assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Lotus NL B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000121</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070504</emdnCode>
    <emdnDescription>GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R231T032B0C0</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:57:05.397Z</lastUpdated>
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    <udiDi>06970895476102</udiDi>
    <basicUdiDi>B-06970895476102</basicUdiDi>
    <tradeName>06970895476102</tradeName>
    <deviceName>2019-Novel Coronavirus, Influenza Virus, Respiratory Syncytial Virus Nucleic Acid Test Kit (Fluorescent Probe-based real-time PCR assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041106</emdnCode>
    <emdnDescription>CORONAVIRUS - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R213T050B0C2</reference>
    <placedOnMarketCountry>Croatia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:57:04.184Z</lastUpdated>
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    <udiDi>06970895476096</udiDi>
    <basicUdiDi>B-06970895476096</basicUdiDi>
    <tradeName>06970895476096</tradeName>
    <deviceName>Influenza A and B virus nucleic acid test kit  (Fluorescent Probe-based real-time PCR assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R083T010B0C1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:57:02.986Z</lastUpdated>
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    <udiDi>06970895476089</udiDi>
    <basicUdiDi>B-06970895476089</basicUdiDi>
    <tradeName>06970895476089</tradeName>
    <deviceName>Influenza A and B virus nucleic acid test kit  (Fluorescent Probe-based real-time PCR assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040504</emdnCode>
    <emdnDescription>INFLUENZA &amp; PARA INFLUENZA - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R083T050B0C1</reference>
    <placedOnMarketCountry>Germany</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:56:56.992Z</lastUpdated>
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    <udiDi>06970895476072</udiDi>
    <basicUdiDi>B-06970895476072</basicUdiDi>
    <tradeName>06970895476072</tradeName>
    <deviceName>Mycoplasma pneumoniae and Macrolides-resistant strain nucleic acid test kit</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010118</emdnCode>
    <emdnDescription>CHLAMYDIA PNEUMONIAE DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R061T016B0C1</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:56:55.790Z</lastUpdated>
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    <udiDi>06970895476041</udiDi>
    <basicUdiDi>B-06970895476041</basicUdiDi>
    <tradeName>06970895476041</tradeName>
    <deviceName>Multi Respiratory Pathogen Real Time PCR Detection Kit</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R23203T2012</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:56:54.579Z</lastUpdated>
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    <udiDi>06970895476034</udiDi>
    <basicUdiDi>B-06970895476034</basicUdiDi>
    <tradeName>06970895476034</tradeName>
    <deviceName>H. Pylori and Multi-Antibiotic Resistance Real-Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010403</emdnCode>
    <emdnDescription>H. PYLORI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B058T050B0C2</reference>
    <placedOnMarketCountry>Czechia</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:56:53.372Z</lastUpdated>
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    <udiDi>06970895476027</udiDi>
    <basicUdiDi>B-06970895476027</basicUdiDi>
    <tradeName>06970895476027</tradeName>
    <deviceName>Herpes Simplex Virus Type I and Type II Typing Nucleic Acid Detection Kit (Fluorescent Probe-Based Real-Time PCR Assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105040311</emdnCode>
    <emdnDescription>HSV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S073T050B0C0</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:56:47.376Z</lastUpdated>
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    <udiDi>06970895476010</udiDi>
    <basicUdiDi>B-06970895476010</basicUdiDi>
    <tradeName>06970895476010</tradeName>
    <deviceName>2019-Novel Coronavirus, Influenza A and B virus nucleic acid test kit (Fluorescent Probe-based Real-time PCR Assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070503</emdnCode>
    <emdnDescription>RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>R20803T2048</reference>
    <placedOnMarketCountry>Bulgaria</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:56:46.174Z</lastUpdated>
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    <udiDi>06970895476003</udiDi>
    <basicUdiDi>B-06970895476003</basicUdiDi>
    <tradeName>06970895476003</tradeName>
    <deviceName>Human Papillomavirus Nucleic Acid Amplification Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041004</emdnCode>
    <emdnDescription>FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S02701T2096</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:56:44.970Z</lastUpdated>
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    <udiDi>06970895475990</udiDi>
    <basicUdiDi>B-06970895475990</basicUdiDi>
    <tradeName>06970895475990</tradeName>
    <deviceName>Urological and Reproductive Tract Microbial Nucleic Acid Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080503</emdnCode>
    <emdnDescription>MANUAL ANTIMICROBIAL SUCEPTIBILITY TESTING (AST)-  STRIPS / CASSETTES/GALLERIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S08203T2024</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:56:43.788Z</lastUpdated>
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    <udiDi>06970895475983</udiDi>
    <basicUdiDi>B-06970895475983</basicUdiDi>
    <tradeName>06970895475983</tradeName>
    <deviceName>Influenza A H1N1(2009) Nucleic Acid Test Kit (Fluorescent Probe-based Real-time PCR Assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</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>R26701T2048</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:56:37.762Z</lastUpdated>
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    <udiDi>06970895475976</udiDi>
    <basicUdiDi>B-06970895475976</basicUdiDi>
    <tradeName>06970895475976</tradeName>
    <deviceName>Urological and Reproductive Tract Microbial Nucleic Acid Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0104080503</emdnCode>
    <emdnDescription>MANUAL ANTIMICROBIAL SUCEPTIBILITY TESTING (AST)-  STRIPS / CASSETTES/GALLERIES</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S08201T2024</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:56:36.565Z</lastUpdated>
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    <udiDi>06970895475969</udiDi>
    <basicUdiDi>B-06970895475969</basicUdiDi>
    <tradeName>06970895475969</tradeName>
    <deviceName>H. Pylori and Multi-Antibiotic Resistance Real-Time PCR Kit</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010403</emdnCode>
    <emdnDescription>H. PYLORI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B05201T2048</reference>
    <placedOnMarketCountry>Spain</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:56:35.367Z</lastUpdated>
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    <udiDi>06970895475952</udiDi>
    <basicUdiDi>B-06970895475952</basicUdiDi>
    <tradeName>06970895475952</tradeName>
    <deviceName>Human Papillomavirus Nucleic Acid Amplification Test Kit (Fluorescent Probe-Based Real-Time PCR Assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041004</emdnCode>
    <emdnDescription>FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S032T048B0C2</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:56:34.170Z</lastUpdated>
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    <udiDi>06970895475945</udiDi>
    <basicUdiDi>B-06970895475945</basicUdiDi>
    <tradeName>06970895475945</tradeName>
    <deviceName>Bloodstream Infections Multiplex Real Time PCR Detection Kit</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105070502</emdnCode>
    <emdnDescription>OTHER MULTIPLE INFECTIOUS - MULTIPLEX NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B80203T2012</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:56:28.171Z</lastUpdated>
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    <udiDi>06970895475938</udiDi>
    <basicUdiDi>B-06970895475938</basicUdiDi>
    <tradeName>06970895475938</tradeName>
    <deviceName>Human Papillomavirus Nucleic Acid Amplification Test Kit (Fluorescent Probe-based Real-time PCR Assay)</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>SUNGO Europe B.V.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>NL-AR-000000247</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105041004</emdnCode>
    <emdnDescription>FULL GENOTYPING HIGH-RISK + LOW-RISK HPV - NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>S031T096B0C2</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:56:26.991Z</lastUpdated>
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    <udiDi>06970895475921</udiDi>
    <basicUdiDi>B-06970895475921</basicUdiDi>
    <tradeName>06970895475921</tradeName>
    <deviceName>Multi-Antibiotic Resistant H.pylori Strain Real Time PCR Detection Kit</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010403</emdnCode>
    <emdnDescription>H. PYLORI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>B055T050B0C2</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:56:25.754Z</lastUpdated>
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    <udiDi>06970895475914</udiDi>
    <basicUdiDi>B-06970895475914</basicUdiDi>
    <tradeName>06970895475914</tradeName>
    <deviceName>Multi-Antibiotic Resistant H.pylori Strain Real Time PCR Detection Kit</deviceName>
    <manufacturerName>Jiangsu Mole Bioscience Co., LTD.</manufacturerName>
    <manufacturerSrn>CN-MF-000001539</manufacturerSrn>
    <authorisedRepresentativeName>Medunion S.L.</authorisedRepresentativeName>
    <authorisedRepresentativeSrn>ES-AR-000019366</authorisedRepresentativeSrn>
    <riskClass>IVD Genel</riskClass>
    <legislation>IVDD</legislation>
    <emdnCode>W0105010403</emdnCode>
    <emdnDescription>H. PYLORI DETECTION BY NA REAGENTS</emdnDescription>
    <deviceStatus>Piyasada</deviceStatus>
    <reference>301100083000</reference>
    <placedOnMarketCountry>Greece</placedOnMarketCountry>
    <lastUpdated>2026-06-30T06:56:24.554Z</lastUpdated>
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