Infectious diseasesInfectious immunology - rapid tests & point of careMultiple pathogens - RT & POC

Other multiple pathogens - RT & POC

Code EMDN W0105090699

62 fabricants, 695 modèles dont 691 en vente, 11 pays. Présents sur le marché en France : 12

Présent sur le marché en Seulement les modèles en vente Pays du fabricant

Fabricants enregistrés en Europe (EUDAMED) 62

En vente
Plus commercialisé
93/42 Ancienne directive, pas encore certifié selon le règlement MDR
Cliquez sur un fabricant pour voir toute sa gamme, sur un modèle pour ouvrir sa fiche EUDAMED.

Fabricant	Pays	Modèles enregistrés	Classe	Contact
Hangzhou Alltest Biotech FDA Mandataire UE : MedNet EC-REP GmbH (Allemagne) et 1 autre	Chine	Adenovirus pneumoniae and RSV Combo Test Cassette FI-AR-50298/79 Adenovirus pneumoniae and RSV Combo Test Cassette(Swab)98/79 Adenovirus pneumoniae/RSV/Influenza A+B ComboTest Cassette98/79 Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19 Combo Test Cassette98/79 Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19/HMPV/HPIV Combo Test Cassette98/79 130 autres Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Rapid Test98/79 Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Rapid Test (Nasopharyngeal Swab)98/79 Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test98/79 Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Rapid Test98/79 CARBA-5 Rapid Test98/79 Chikungumya lgG&lgM/Dengue lgG&lgM/Dengue NS1 Combo Rapid Test98/79 Chikungunya/Zika Combo Rapid Test ICZ-42598/79 Dengue NS1 and Zika NS1 Combo Rapid Test98/79 Dengue Ns1/Dengue lgG&lgM/Chikungunya lgG&lgM/West Nile Virus lgG&lgM Combo Rapid Test98/79 Dengue Ns1/Dengue lgG&lgM/Chikungunya lgG&lgM/zika lgG&lgM Combo Rapid Test98/79 HAV IgG/IgM&Syphilis Combo Rapid Test IHAS-43598/79 HAV IgM&Syphilis Combo Rapid Test IHAS-42598/79 HSV 1/2 IgG/IgM Combo Rapid Test Cassette98/79 Influenza A/B + H5N1 Antigen Combo Rapid Test98/79 Influenza A/B +H1N1 Combo Rapid Test Cassette with LF READER PLUS98/79 Influenza A/B+H1N1+H5N1 Antigen Combo Rapid Test98/79 Multiplex Respiratory Antigen Rapid Test (Flu B/Flu A/HPIV 1/3/HPIV 2/HMPV/Adeno/MP/RSV/COVID-19)98/79 Multiplex Respiratory Antigen Rapid Test IRT9-55598/79 Multiplex Respiratory Antigen Rapid Test IRT9-R55598/79 Multiplex Respiratory Antigen Rapid Test IRTC-510598/79 Multiplex Respiratory Antigen Rapid Test IRTC-5105(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5105(DSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5105(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-511598/79 Multiplex Respiratory Antigen Rapid Test IRTC-5115(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5115(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-512598/79 Multiplex Respiratory Antigen Rapid Test IRTC-5125(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5125(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-513598/79 Multiplex Respiratory Antigen Rapid Test IRTC-5135(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5135(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-514598/79 Multiplex Respiratory Antigen Rapid Test IRTC-5145(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5145(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-515598/79 Multiplex Respiratory Antigen Rapid Test IRTC-5155(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5155(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5165(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5165(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5175(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5175(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5185(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5185(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5195(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5195(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5205(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5205(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5215(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-52598/79 Multiplex Respiratory Antigen Rapid Test IRTC-525(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-525(DSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-525(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-53598/79 Multiplex Respiratory Antigen Rapid Test IRTC-535(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-535(DSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-535(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-54598/79 Multiplex Respiratory Antigen Rapid Test IRTC-545(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-545(DSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-545(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-55598/79 Multiplex Respiratory Antigen Rapid Test IRTC-555(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-555(DSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-555(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-56598/79 Multiplex Respiratory Antigen Rapid Test IRTC-565(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-565(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-57598/79 Multiplex Respiratory Antigen Rapid Test IRTC-575(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-575(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-58598/79 Multiplex Respiratory Antigen Rapid Test IRTC-585(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-585(DSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-585(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-59598/79 Multiplex Respiratory Antigen Rapid Test IRTC-595(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-595(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5X598/79 Multiplex Respiratory Antigen Rapid Test IRTC-5X5(B)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5X5(DSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-5X5(SSW)98/79 Multiplex Respiratory Antigen Rapid Test IRTC-R510598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R511598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R512598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R513598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R514598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R515598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R52598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R53598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R54598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R55598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R56598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R57598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R58598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R59598/79 Multiplex Respiratory Antigen Rapid Test IRTC-R5X598/79 Norovirus+Rotavirus+Adenovirus+Astrovirus Combo Rapid Test IMVD-R64598/79 Norovirus+Rotavirus/Adenovirus+Astrovirus+Enterovirus Combo Rapid Test IMVD-65598/79 Norovirus/Rotavirus/Adenovirus Combo Rapid Test INRA-63798/79 Norovirus/Rotavirus/Adenovirus Combo Rapid Test INRA-RT63598/79 Norovirus/Rotavirus/Adenovirus Combo Test Cassette FI-NRA-63598/79 Respiratory Infectious Diseases Rapid Test IRT-510798/79 Respiratory Infectious Diseases Rapid Test IRT-511798/79 Respiratory Infectious Diseases Rapid Test IRT-512798/79 Respiratory Infectious Diseases Rapid Test IRT-513798/79 Respiratory Infectious Diseases Rapid Test IRT-514798/79 Respiratory Infectious Diseases Rapid Test IRT-515798/79 Respiratory Infectious Diseases Rapid Test IRT-52798/79 Respiratory Infectious Diseases Rapid Test IRT-53798/79 Respiratory Infectious Diseases Rapid Test IRT-54798/79 Respiratory Infectious Diseases Rapid Test IRT-55798/79 Respiratory Infectious Diseases Rapid Test IRT-56798/79 Respiratory Infectious Diseases Rapid Test IRT-57798/79 Respiratory Infectious Diseases Rapid Test IRT-58798/79 Respiratory Infectious Diseases Rapid Test IRT-59798/79 Respiratory Infectious Diseases Rapid Test IRT-5X798/79 Rotavirus Group A and Norovirus GI/GII RT-qPCR Kit2 réf.98/79 Rotavirus/Adenovirus+Astrovirus Combo Rapid Test IRAA-62598/79 RSV &Influenza A+B Combo Rapid Test Cassette IRIC-R52598/79 RSV and SARS-CoV-2 Antigen Combo Rapid Test98/79 RSV&Influenza A+B Combo Rapid Test Cassette IRIC-52598/79 RSV/Influenza A+B/COVID-19 Combo Test Cassette98/79 SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/ Adenovirus Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/ Adenovirus/ M.pneumoniae Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/ Adenovirus/M. pneumoniae Control98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test (Nasopharyngeal Swab)98/79 Trichomonas vaginalis/Gardnerella vaginalis/Candida albicans Combo Rapid Test98/79 TropiDetect Triple Test98/79	– 98/79	Présent sur le marché en France info@alltests.com.cn Fiche EUDAMED Signaler une erreur
Acro Biotech FDA Mandataire UE : MedNet EC-REP GmbH (Allemagne) et 1 autre	États-Unis	Adenovirus / RSV / Influenza A+B Combo Rapid Test Cassette IARI-R53598/79 Adenovirus and RSV Combo Rapid Test Cassette (Nasopharyngeal Swab) IARC-R52598/79 Adenovirus pneumoniae/RSV/Influenza A+B Combo Test Cassette acrARF535F98/79 Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19 Combo Test Cassette98/79 Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19/HMPV/HPIV Combo Test Cassette98/79 56 autres Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Rapid Test (Nasopharyngeal Swab)98/79 Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Rapid Test98/79 Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test98/79 Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test (Nasopharyngeal Swab)98/79 Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Rapid Test98/79 Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Rapid Test (Nasopharyngeal Swab)98/79 Chikungunya and Dengue Combo Rapid Test acrCKDE43598/79 Chikungunya/Zika Combo Rapid Test ICZ-ACO42598/79 Dengue NS1 and Zika NS1 Combo Rapid Test98/79 Dengue/Chikungunya/West Nile Virus Combo Rapid Test acrDCW44598/79 Dengue/Chikungunya/Zika Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) IDCZ-R43598/79 Dengue/Chikungunya/Zika Combo Rapid Test Cassette IDCZ-ACO43598/79 Dengue/Zika/Chikungunya Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) IDZC-R44598/79 Dengue/Zika/Chikungunya Combo Rapid Test Cassette IDZC-ACO44598/79 HAV IgG/IgM&Syphilis Combo Rapid Test IHAS-ACO43598/79 HAV IgM&Syphilis Combo Rapid Test IHAS-ACO42598/79 HSV 1/2 IgG Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 HSV 1/2 IgG/IgM Combo Rapid Test Cassette98/79 HSV 1/2 IgG/IgM Combo Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 HSV 1/2 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 HSV 1/2 IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)98/79 Multiplex Respiratory Antigen Rapid Test (Swab) acrRTC595R98/79 Mycoplasma pneumoniae/Adenovirus pneumoniae/ RSV/Influenza A+B/COVID-19/HMPV/HPIV Combo Test Cassette98/79 Norovirus+Rotavirus+Adenovirus+Astrovirus Combo Rapid Test IMVD-R64598/79 Norovirus+Rotavirus/Adenovirus+Astrovirus+Enterovirus Combo Rapid Test IMVD-ACO65598/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test IMVD-ACO64798/79 Norovirus/Rotavirus/Adenovirus Combo Rapid Test (Feces) INRA-R63798/79 Norovirus/Rotavirus/Adenovirus Combo Rapid Test Cassette INRA-RT63598/79 Norovirus/Rotavirus/Adenovirus Combo Rapid Test INRA-ACO63798/79 Norovirus/Rotavirus/Adenovirus Combo Test Cassette ACO-NRA-63598/79 Respiratory Antigen Rapid Combo Test (Swab) RTC5E98/79 Respiratory Antigen Rapid Combo Test acrMRA585R98/79 Respiratory Antigen Rapid Combo Test acrMRA595R98/79 Respiratory Antigen Rapid Combo Test IRTC-ACO58598/79 Respiratory Antigen Rapid Combo Test IRTC-ACO59598/79 Respiratory Infectious Diseases Rapid Test I(Analytes)-ACO5X798/79 Respiratory Infectious Diseases Rapid Test IAD-ACO50798/79 Respiratory Infectious Diseases Rapid Test IHMPV-ACO50798/79 Respiratory Infectious Diseases Rapid Test IIN-ACO50798/79 Respiratory Infectious Diseases Rapid Test IMP-ACO50798/79 Respiratory Infectious Diseases Rapid Test IMR-ACO50798/79 Respiratory Infectious Diseases Rapid Test INCP-ACO50798/79 Respiratory Infectious Diseases Rapid Test IPIV-ACO50798/79 Respiratory Infectious Diseases Rapid Test IRHV-ACO50798/79 Respiratory Infectious Diseases Rapid Test IRS-ACO50798/79 Respiratory Infectious Diseases Rapid Test IRT-ACO52798/79 Respiratory Infectious Diseases Rapid Test IRT-ACO53798/79 Respiratory Infectious Diseases Rapid Test IRT-ACO54798/79 Respiratory Infectious Diseases Rapid Test IRT-ACO55798/79 Respiratory Infectious Diseases Rapid Test IRT-ACO56798/79 Rotavirus and Adenovirus Combo Rapid Test IRAC-ACO62798/79 Rotavirus/Adenovirus+Astrovirus Combo Rapid Test IRAA-ACO62598/79 RSV/Influenza A+B/COVID-19 Combo Test Cassette98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test (Nasopharyngeal Swab)98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test2 réf.98/79	– 98/79	Présent sur le marché en France info@acrobiotech.com Fiche EUDAMED Signaler une erreur
Vitrosens	Turquie	RapidFor™12 réf. RapidFor™ CT + NG v2.0 Test Kit RapidFor™ SARS-CoV-2 + FLU A/B + HPIV + RSV + ADV Test Kit RapidFor™ SARS-CoV-2 + FLU A/B + RSV + ADV + MP + hMPV + HPIV + RhV Test Kit RapidFor™ SARS-CoV-2 + FLU A/B + RSV + ADV + MP Test Kit3 réf. 47 autres RapidFor™ SARS-CoV-2 + FLU A/B + RSV + ADV + hMPV + HPIV Test Kit RapidFor™ SARS-CoV-2 + FLU A/B + RSV + ADV + hMPV Test Kit3 réf. RapidFor™ SARS-CoV-2 + FLU A/B + RSV + ADV + RhV + hMPV Test Kit3 réf. RapidFor™ SARS-CoV-2 + FLU A/B + RSV + ADV Test Kit3 réf. RapidFor™ SARS-CoV-2 + FLU A/B + RSV + MP + HPIV Test Kit RapidFor™ SARS-CoV-2 + FLU A/B + RSV + hMPV Test Kit2 réf. RapidFor™ SARS-CoV-2 + FLU A/B + RSV Test Kit3 réf. RapidFor™ SARS-CoV-2 + RSV + ADV Test Kit3 réf. RapidFor™ SARS-CoV-2 + RSV Test Kit2 réf. RapidFor™ VMD101BC98/79 RapidFor™ VMD101FD98/79 RapidFor™ VMD109STS RapidFor™ VMD112FD98/79 RapidFor™ VMD135FD98/79 RapidFor™ VMD141SC98/79 RapidFor™ VMD146BC98/79 RapidFor™ VMD146TD98/79 RapidFor™ VMD152FD98/79 RapidFor™ VMD152SC98/79 RapidFor™ VMD154SC98/79 RapidFor™ VMD155FD98/79 RapidFor™ VMD155SC2098/79 RapidFor™ VMD157FD98/79 RapidFor™ VMD157SC98/79 RapidFor™ VMD158FD98/79 RapidFor™ VMD158SC98/79 RapidFor™ VMD159FD98/79 RapidFor™ VMD159SC98/79 RapidFor™ VMD175FD98/79 RapidFor™ VMD176STS98/79 RapidFor™ VMD187FD98/79 RapidFor™ VMD188SC98/79 RapidFor™ VMD71BC98/79 RapidFor™ VMD71FD98/79 RapidFor™ VMD71SC98/79 RapidFor™ VMD71SD0198/79 RapidFor™ VMD78FD98/79 RapidFor™ VMD78SC98/79 RapidFor™ VMD79FD98/79 RapidFor™ VMD79SC0198/79 RapidFor™ VMD79TD0198/79 RapidFor™ VMD80BC98/79 RapidFor™ VMD80FD98/79 RapidFor™ VMD81SC98/79 RapidFor™ VMD95FD98/79 RapidFor™ VMD95SC98/79 RapidFor™ VMD95TD98/79	B, C IVDR, 98/79	Site web info@vitrosens.com Fiche EUDAMED Signaler une erreur
Wuhan Life Origin Biotech Joint Stock Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae Antigen Combined Detection Kit (Colloidal Gold) 1 test/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae Antigen Combined Detection Kit (Colloidal Gold) 10 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae Antigen Combined Detection Kit (Colloidal Gold) 100 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae Antigen Combined Detection Kit (Colloidal Gold) 25 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae Antigen Combined Detection Kit (Colloidal Gold) 5 tests/kit98/79 29 autres Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae Antigen Combined Detection Kit (Colloidal Gold) 50 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae, Human Metapneumovirus, Parainfluenza 1/2/3, Rhinovirus Antigen Combined Detection Kit (Colloidal Gold) 1 test/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae, Human Metapneumovirus, Parainfluenza 1/2/3, Rhinovirus Antigen Combined Detection Kit (Colloidal Gold) 10 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae, Human Metapneumovirus, Parainfluenza 1/2/3, Rhinovirus Antigen Combined Detection Kit (Colloidal Gold) 100 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae, Human Metapneumovirus, Parainfluenza 1/2/3, Rhinovirus Antigen Combined Detection Kit (Colloidal Gold) 25 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae, Human Metapneumovirus, Parainfluenza 1/2/3, Rhinovirus Antigen Combined Detection Kit (Colloidal Gold) 5 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Adenovirus, Respiratory Syncytial Virus, Mycoplasma Pneumoniae, Human Metapneumovirus, Parainfluenza 1/2/3, Rhinovirus Antigen Combined Detection Kit (Colloidal Gold) 50 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Colloidal Gold) 1 test/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Colloidal Gold) 10 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Colloidal Gold) 100 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Colloidal Gold) 25 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Colloidal Gold) 5 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Colloidal Gold) 50 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Fluorescence Immunochromatographic Assay) 1 test/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Fluorescence Immunochromatographic Assay) 10 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Fluorescence Immunochromatographic Assay) 100 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Fluorescence Immunochromatographic Assay) 25 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Fluorescence Immunochromatographic Assay) 5 tests/kit98/79 Influenza A Virus, Influenza B Virus, 2019-nCoV, Respiratory Syncytial Virus Antigen Combined Detection Kit (Fluorescence Immunochromatographic Assay) 50 tests/kit98/79 Rota/Adeno Antigen Assay Kit(Fluorescence Immunochromatographic Assay) 10 tests/kit98/79 Rota/Adeno Antigen Assay Kit(Fluorescence Immunochromatographic Assay) 100 tests/kit98/79 Rota/Adeno Antigen Assay Kit(Fluorescence Immunochromatographic Assay) 25 tests/kit98/79 Rota/Adeno Antigen Assay Kit(Fluorescence Immunochromatographic Assay) 50 tests/kit98/79 SARS-CoV-2/Influenza A Virus/Influenza B Virus/Respiratory Syncytial Virus/Adenovirus/Parainfluenza Virus/Rhinovirus Antigen Combined Assay Kit(Colloidal Gold) 1 test/kit98/79 SARS-CoV-2/Influenza A Virus/Influenza B Virus/Respiratory Syncytial Virus/Adenovirus/Parainfluenza Virus/Rhinovirus Antigen Combined Assay Kit(Colloidal Gold) 10 tests/kit98/79 SARS-CoV-2/Influenza A Virus/Influenza B Virus/Respiratory Syncytial Virus/Adenovirus/Parainfluenza Virus/Rhinovirus Antigen Combined Assay Kit(Colloidal Gold) 100 tests/kit98/79 SARS-CoV-2/Influenza A Virus/Influenza B Virus/Respiratory Syncytial Virus/Adenovirus/Parainfluenza Virus/Rhinovirus Antigen Combined Assay Kit(Colloidal Gold) 25 tests/kit98/79 SARS-CoV-2/Influenza A Virus/Influenza B Virus/Respiratory Syncytial Virus/Adenovirus/Parainfluenza Virus/Rhinovirus Antigen Combined Assay Kit(Colloidal Gold) 5 tests/kit98/79 SARS-CoV-2/Influenza A Virus/Influenza B Virus/Respiratory Syncytial Virus/Adenovirus/Parainfluenza Virus/Rhinovirus Antigen Combined Assay Kit(Colloidal Gold) 50 tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Acesolab FDA Mandataire UE : VidaQuick Biotech S.L. (Espagne)	États-Unis	Adenovirus &RSV Combo Test SW25-ARC98/79 Adenovirus pneumoniae and RSV Combo FIA Test98/79 Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19 Combo FIA Test98/79 Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19/HMPV/HPIV Combo FIA Test98/79 Adenovirus, RSV & Flu A+B Combo Test98/79 28 autres Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Test98/79 Adenovirus/RSV/HMPV/Influenza A+B Combo Test98/79 Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Test98/79 Adenovirus/RSV/Influenza A+B Combo FIA Test98/79 Chikungunya/Zika Combo Test BSP25-CZ98/79 Dengue/Chikungunya/Zika Combo Test BSP35-DCZ98/79 Dengue/Zika/Chikungunya Combo Test BSP45-DZC98/79 HSV 1/2 IgG Test2 réf.98/79 HSV 1/2 IgG/IgM Test4 réf.98/79 HSV 1/2 IgM Test2 réf.98/79 Multi-Respiratory Antigen Test SW55-RT998/79 Multi-Respiratory Antigen Test SW67-RTC98/79 Multi-Respiratory Antigen Test SW85-RTC98/79 Mycoplasma pneumoniae/Adenovirus pneumoniae/ RSV/Influenza A+B/COVID-19/HMPV/HPIV Combo FIA Test98/79 Norovirus+Rotavirus, Adenovirus +Astrovirus+Enterovirus Combo Test F55-NRAAE98/79 Norovirus, Rotavirus & Adenovirus Combo Test F35-NRA98/79 Norovirus, Rotavirus & Adenovirus Combo Test F37-NRA98/79 Norovirus, Rotavirus, Adenovirus & Astrovirus Combo Test F45-NRAA98/79 Norovirus, Rotavirus, Adenovirus & Astrovirus Combo Test F47-NRAA98/79 Norovirus/Rotavirus/Adeno virus Combo FIA Test98/79 Rotavirus & Adenovirus Combo Test F02-RA98/79 Rotavirus & Adenovirus Combo Test F07-RA98/79 Rotavirus and Adenovirus FIA Test98/79 RSV&Flu A+B Combo Test98/79 SARS-CoV-2 & M.pneumoniae IgG Combo Test98/79 SARS-CoV-2 & M.pneumoniae IgG/IgM Combo Test98/79 SARS-CoV-2/Flu A+B/RSV/Adenovirus Ag Combo Test98/79 SARS-CoV-2/Flu A+B/RSV/Adenovirus/M.pneumoniae Ag Combo Test98/79	– 98/79	info@acesolab.com Fiche EUDAMED Signaler une erreur
Newlink Biotech Mandataire UE : VidaQuick Biotech S.L. (Espagne)	Chine	Adenovirus pneumoniae and RSV Combo Assay F11-AR01C598/79 Adenovirus&RSV Combo Rapid Test L11-AR02C598/79 Adenovirus, RSV and Influenza A+B Combo Rapid Test L11-ARI03C598/79 Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Rapid Test98/79 HSV 1/2 IgG Rapid Test2 réf.98/79 26 autres HSV 1/2 IgG/IgM Rapid Test4 réf.98/79 HSV 1/2 IgM Rapid Test2 réf.98/79 Multiplex Respiratory Antigen Rapid Test L11-RT905C598/79 Multiplex Respiratory Antigen Rapid Test L11-RTC02C598/79 Multiplex Respiratory Antigen Rapid Test L11-RTC03C598/79 Multiplex Respiratory Antigen Rapid Test L11-RTC04C598/79 Multiplex Respiratory Antigen Rapid Test L11-RTC05C598/79 Multiplex Respiratory Antigen Rapid Test L11-RTC06C598/79 Multiplex Respiratory Antigen Rapid Test L11-RTC07C598/79 Multiplex Respiratory Antigen Rapid Test L11-RTCXXC598/79 Norovirus, Rotavirus and Adenovirus Combo Rapid Test L11-NRA02C698/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test L11-NRAA03C698/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test L11-NRAA03F698/79 One Step Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Test98/79 One Step Adenovirus/RSV/HMPV/Influenza A+B Combo Test98/79 One Step Dengue/Chikungunya/Zika Combo Test98/79 One Step Dengue/Zika/Chikungunya Combo Test98/79 One Step Norovirus, Rotavirus and Adenovirus Combo Test98/79 One Step SARS-CoV-2 and M.pneumoniae IgG Combo Test98/79 Rotavirus and Adenovirus Assay F11-RAC01C698/79 Rotavirus and Adenovirus Combo Rapid Test L11-RAC01C698/79 Rotavirus and Adenovirus Combo Rapid Test L11-RAC01F698/79 RSV&Influenza A+B Combo Rapid Test L11-RI02C598/79 SARS-CoV-2 and M.pneumoniae IgG/IgM Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test98/79	– 98/79	Site web info@kylinew.com Fiche EUDAMED Signaler une erreur
Rapid Labs Mandataire UE : Advena Limited (Malte) et 1 autre	United Kingdom (ex Northern Ireland)	Adenovirus pneumoniae and RSV Combo Test Device- Nasopharyngeal Swab D-FIARNSD2098/79 Adenovirus pneumoniae/RSV/Influenza A+B Combo Test Device-Nasopharyngeal Swab D-FIARID2098/79 Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19 Combo Test Device-Nasopharyngeal Swab98/79 Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19/HMPV/HPIV Combo Test Device-Nasopharyngeal Swab98/79 Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test Device-Swab98/79 20 autres Adenovirus/RSV/HMPV/Influenza A+B/COVID-19 Combo Rapid Test Device-Swab98/79 Dengue/Zika/Chikungunya Combo Rapid Test Device-WB/S/P98/79 Multiplex 5 Respiratory Antigen Rapid Test Device-Swab2 réf.98/79 Multiplex 6 Respiratory Antigen Rapid Test Device-Swab2 réf.98/79 Multiplex 7 Respiratory Antigen Rapid Test Device-Swab2 réf.98/79 Multiplex 8 Respiratory Antigen Rapid Test Device-Swab2 réf.98/79 Multiplex 9 Respiratory Antigen Rapid Test Device-Swab2 réf.98/79 Mycoplasma pneumoniae/Adenovirus pneumoniae/RSV/Influenza A+B/COVID-19/HMPV/HPIV Combo Test Device-Nasopharyngeal Swab98/79 Norovirus+Rotavirus/Adenovirus+Astrovirus+Enterovirus Combo Rapid Test Device-Feces D-NRAAED1098/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test Device - Feces D-NRAAD0198/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test Device - Feces D-NRAAD1098/79 Norovirus/Rotavirus/Adenovirus Combo Test Device-Feces D-FINRAD1098/79 Norovirus/Rotavirus/Adenovirus Combo Test Device-Feces D-FINRAD2598/79 Rotavirus and Adenovirus Test Device-Feces D-FIROAAGD1098/79 Rotavirus and Adenovirus Test Device-Feces D-FIROAAGD2598/79 RSV/HMPV Combo Rapid Test Device-Nasopharyngeal Swab98/79 RSV/HMPV/Adenovirus/HPIV/Influenza A+B Combo Rapid Test Device98/79 SARS-CoV-2 & Inﬂuenza A+B & RSV & Adenovirus & M.pneumoniae Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test Device-Nasopharyngeal Swab2 réf.98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test-Nasopharyngeal Swab98/79	– 98/79	Site web info@rapidlabs.co.uk Fiche EUDAMED Signaler une erreur
Tongzhoubio FDA Mandataire UE : VidaQuick Biotech S.L. (Espagne)	Chine	Adenovirus&RSV Combo Rapid Test I055-502598/79 Adenovirus, RSV and Influenza A+B Combo Rapid Test I056-503598/79 Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Rapid Test98/79 Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test98/79 Chikungunya and Dengue Combo Rapid Test I202-403598/79 18 autres HSV 1/2 IgG Rapid Test (S/P)98/79 HSV 1/2 IgG Rapid Test (WB/S/P)98/79 HSV 1/2 IgG/IgM Combo Rapid Test2 réf.98/79 HSV 1/2 IgG/IgM Rapid Test (Serum/Plasma)98/79 HSV 1/2 IgG/IgM Rapid Test (Whole Blood/Serum/Plasma)98/79 HSV 1/2 IgM Rapid Test (Serum/Plasma)98/79 HSV 1/2 IgM Rapid Test (Whole Blood/Serum/Plasma)98/79 Multiplex Respiratory Virus Antigen Rapid Test I161-507598/79 Multiplex Respiratory Virus Antigen Rapid Test I161-5XX598/79 Norovirus, Rotavirus and Adenovirus Combo Rapid Test I009-603598/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test Cup I011-604798/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test I011-604598/79 RSV&Influenza A+B Combo Rapid Test I054-502598/79 SARS-CoV-2 and M.pneumoniae IgG Combo Rapid Test98/79 SARS-CoV-2 and M.pneumoniae IgG/IgM Combo Rapid Test98/79 SARS-CoV-2 and RSV Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Bitrumed Mandataire UE : VidaQuick Biotech S.L. (Espagne)	Chine	Adenovirus &RSV Combo Test AR-5C298/79 Adenovirus, RSV & Flu A+B Combo Test98/79 Adenovirus/RSV/HMPV/HPIV/Influenza A+B Ag Combo Test98/79 Dengue/Chikungunya/Zika Combo Test DCZ-4C398/79 Dengue/Zika/Chikungunya Combo Test DZC-4C498/79 15 autres HSV 1/2 IgG Test2 réf.98/79 HSV 1/2 IgG/IgM Test4 réf.98/79 HSV 1/2 IgM Test2 réf.98/79 Norovirus, Rotavirus & Adenovirus Test NRA-6C298/79 Norovirus, Rotavirus & Adenovirus Test NRA-6F298/79 Norovirus, Rotavirus, Adenovirus & Astrovirus Combo Test NRAA-6C398/79 Norovirus, Rotavirus, Adenovirus & Astrovirus Combo Test NRAA-6F498/79 Rotavirus & Adenovirus Test RA-6C198/79 Rotavirus & Adenovirus Test RA-6F198/79 Rotavirus and Adenovirus Combo Rapid Test Cassette IRAC-62598/79 RSV&Flu A+B Combo Test98/79 SARS-CoV-2 & M.pneumoniae IgG Combo Test98/79 SARS-CoV-2 & M.pneumoniae IgG/IgM Combo Test98/79 SARS-CoV-2/Flu A+B/RSV/Adenovirus Ag Combo Test98/79 SARS-CoV-2/Flu A+B/RSV/Adenovirus/M.pneumoniae Ag Combo Test98/79	– 98/79	info@bitrumed.com.cn Fiche EUDAMED Signaler une erreur
Actest Mandataire UE : VidaQuick Biotech S.L. (Espagne)	Chine	Adenovirus, RSV and Influenza A+B Combo Rapid Test Cassette ARAB-5-L98/79 Adenovirus, RSV and Influenza A+B Combo Rapid Test Cassette ARI-5-E98/79 Adenovirus/RSV/HMPV/HPIV/Influenza A+B Combo Rapid Test98/79 Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test98/79 Adenovirus/RSV/HMPV/SARS-CoV-2/Influenza A+B Combo Rapid Test98/79 13 autres COVID-19 and M.pneumoniae IgG/IgM Combo Rapid Test98/79 Dengue IgG&IgM/Zika IgG&IgM/Chikungunya IgG/Chikungunya IgM Combo Rapid Test Cassette DZC-5-D98/79 HSV 1/2 IgG/IgM Rapid Test Cassette2 réf.98/79 Multiplex Respiratory Antigen Rapid Test RT9-5-E98/79 Norovirus, Rotavirus and Adenovirus Combo Rapid Test Cassette NRA-5-F98/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test Cassette NRAA-5-F98/79 Norovirus, Rotavirus, Adenovirus and Astrovirus Combo Rapid Test NRAA-7-F98/79 Rotavirus and Adenovirus Combo Rapid Test Cassette ROA-2-F98/79 Rotavirus and Adenovirus Rapid Test ROA-7-F98/79 RSV&Influenza A+B Combo Rapid Test Cassette RVIF-5-K98/79 RSV/HMPV Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV/Adenovirus/M.pneumoniae Antigen Combo Rapid Test98/79	– 98/79	info@actest.com.cn Fiche EUDAMED Signaler une erreur
Dezhou Guoke Medical Technology Mandataire UE : MedPath GmbH (Allemagne) et 1 autre	Chine	Candida albicans / Trichomonas vaginalis / Gardnerella vaginalis Triplex Rapid Test Kit98/79 COVID-19&Flu A/B&RSV&Adenovirus Antigen Combo Rapid Test Cassette(Colloidal Gold ) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 COVID-19&Flu A/B&RSV&Adenovirus&MP&HMPV Antigen Combo Rapid Test Cassette(Colloidal Gold ) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 COVID-19&Flu A/B&RSV&Adenovirus&MPAntigen Combo Rapid TestCassette(Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 Dengue Virus IgG/IgM/NS1 & Chikungunya Virus IgM/IgG Combo Rapid Test Kit98/79 12 autres Enterovirus 71 (EV71) and Coxsackievirus A16 (CA16) Antigen Combo Rapid Test Kit98/79 Enterovirus 71 (EV71) IgM/IgG Antibody and Coxsackievirus A16 (CA16) IgM/IgG Antibody Combo Rapid Test Kit98/79 Group A Rotavirus & Adenovirus & Norovirus Ag Detection Kit (Immunofluorescence Chromatography)98/79 Group A Rotavirus / Adenovirus / Norovirus Antigen Triplex Rapid Test Kit98/79 Influenza A/B & RSV & Adenovirus & hMPV & PIV & M. pneumoniae Ag Combo Rapid Test Kit98/79 Influenza A/B, SARS-CoV-2, RSV, Adenovirus, Measles Virus, Mumps Virus and HPIV Antigen Combo Rapid Test Kit98/79 Rotavirus / Adenovirus / Norovirus (GI/GII) Ag Combo Rapid Test Kit98/79 RSV & ADV Ag Detection Kit (Immunofluorescence Chromatography)98/79 SARS-CoV-2 / Flu A / Flu B/ ADV Ag Combo Rapid Test Kit98/79 SARS-CoV-2, Influenza A/B, RSV, Adenovirus, M. pneumoniae, hMPV, Rhinovirus, hPIV (1/2/3) and B. pertussis Antigen Combo Rapid Test Kit98/79 Toxoplasma gondii IgG/IgM, CMV IgG/IgM and Rubella Virus IgG Antibody Combo Rapid Test Kit98/79 Zika Virus IgG/IgM Antibody and Yellow Fever Virus IgG/IgM Antibody Combo Rapid Test Kit98/79	– 98/79	office@guoke-medical.com Fiche EUDAMED Signaler une erreur
Medotexbio Mandataire UE : Llins Service & Consulting GmbH (Allemagne)	Chine	10-in-1 Respiratory Antigen Combo Rapid Test RVC-5105a-25M 12-in-1 Respiratory Antigen Combo Rapid Test98/79 5-in-1 Respiratory Antigen Combo Rapid Test 6-in-1 Respiratory Antigen Combo Rapid Test98/79 8-in-1 Respiratory Antigen Combo Rapid Test RVC-585b98/79 12 autres 8-in-1 Respiratory Antigen Combo Rapid Test RVC-585b-25M Flu A&B/SARS-CoV-2/RSV Antigen Combo Test Flu A&B/SARS-CoV-2/RSV/ADV Antigen Combo Test Flu A&B/SARS-CoV-2/RSV/ADV Antigen Combo Test RVC-555b98/79 Flu A&B/SARS-CoV-2/RSV/ADV/hPIV Antigen Combo Rapid Test98/79 Flu A&B/SARS-CoV-2/RSV/ADV/MP Antigen Combo Rapid Test98/79 Flu A&B/SARS-CoV-2/RSV/hMPV Antigen Combo Test98/79 Norovirus/Rotavirus/Adenovirus Antigen Combo Rapid Test GIC-635a98/79 Respiratory Multiple Antigen Combo Test RVC-5X598/79 Rotavirus/Adenovirus Combo Rapid Test RAC-622a98/79 RVC-5105a98/79 RVC-585c98/79	B IVDR, 98/79	Site web Fiche EUDAMED Signaler une erreur
Vi̇si̇on Bi̇yoteknoloji̇ Araştirma Geli̇şti̇rme Laboratuvar Si̇stemleri̇ Sanayi̇ Ve Ti̇caret Şi̇rketi̇	Turquie	3'Ü 1 ARADA SOLUNUM HIZLI TEST KİTİ RESPIRATORY 3 IN 1 RAPID TEST KIT 4'Ü 1 ARADA SOLUNUM HIZLI TEST KİTİ RESPIRATORY 4 IN 1 RAPID TEST KIT 5'İ 1 ARADA SOLUNUM HIZLI TEST KİTİ RESPIRATORY 5 IN 1 RAPID TEST KIT Beyaz Akciğer Sendromu Mini Panel Hızlı Test Kiti COVID-19 A/B- RSV- ADENO ÇOKLU HIZLI TEST KİTİ 12 autres COVID-INF A/B- RSV MULTI RAPID TEST KIT COVID-INF A/B- RSV- ADENO- HMPV MULTI RAPID TEST KIT FLU A/B-RSV RAPID TEST KIT INFLUENZA A/B RSV RAPID TEST KIT VISD073 İNFLUENZA A-B/RSV/ADENO HIZLI TEST KİTİ NOROVIRUS-ROTAVIRUS AG RAPID TEST KIT VISD134 ROTA-ADENO-ASTRO-NOROVİRÜS ÇOKLU HIZLI TEST KİTİ ROTA-ADENO-NOROVIRUS RAPID TEST KIT ROTAVIRUS-ADENOVIRUS AG RAPID TEST VISD009 STREPTOCOCCUS PNEUMONIAE-LEGIONELLA PNEUMOPHILA HIZLI TEST KİTİ TORCH IgG-IgM RAPID TEST KIT White Lung Syndrome Middle Panel Rapid Test Kit VISD079	B, C IVDR	Site web info@visionbiotechnology.com Fiche EUDAMED Signaler une erreur
Assure Tech. (Hangzhou) Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 2 autres	Chine	C. difficile Toxin A/B Rapid Test Format (cassette): A4A93011 A4A930125 A4A930140 A4A93021 A4A930225 A4A930240 COVID-19 & Influenza A/B & RSV & ADV & HMPV Antigen Combo Test COVID-19 & Influenza A/B & RSV Antigen Combo Rapid Test98/79 COVID-19& Influenza A/B& RSV Antigen Combo Test Format (cassette): A4981011 A49810120 A49810140 A4981021 A49810220 A49810240 Format (pen): A4776011 A47760120 A4776021 A47760220 COVID-19&Influenza A/B Antigen combo Test Format (cassette): A4943011 A49430120 A49430140 A4943021 A49430220 A49430240 Format (pen): A4766011 A47660120 A4766021 A47660220 11 autres COVID-19&Influenza A/B&RSV&ADV Antigen combo Test Format (cassette): A4933011 A49330120 A49330140 A4933021 A49330220 A49330240 Format (pen): A4956011 A49560120 A4956021 A49560220 COVID-19&Influenza A/B&RSV&ADV&MP Antigen combo Test Format (cassette): A4923011 A49230120 A49230140 A4923021 A49230220 A49230240 Format (pen): A4D56011 A4D560120 A4D56021 A4D560220 COVID-19&Influenza A/B&RSV&ADV&MP&HMPV Antigen combo Test Format (cassette): A4D73011 A4D730120 A4D730140 A4D73021 A4D730220 A4D730240 COVID-19&Influenza A/B&RSV&ADV&MP&HMPV&HPIV Antigen combo Test Format (cassette): A4D83011 A4D830120 A4D830140 A4D83021 A4D830220 A4D830240 FLU A/FLU B/RSV/ADV/MP/COVID-19 Combo Test98/79 Influenza A/B & RSV & ADV Antigen Combo Test Influenza A/B & RSV Antigen Combo Test A4C83011 Influenza A/B&ADV Antigen combo Test Format (cassette): A4D33011 A4D330120 A4D330140 A4D33021 A4D330220 A4D330240 Format (pen): A4D36011 A4D360120 A4D36021 A4D360220 Rotavirus-Adenovirus-Astrovirus-Norovirus Combo Test A4B630 Rotavirus-Adenovirus-Astrovirus-Norovirus Combo test AT-MI-F4400198/79 Rotavirus-Adenovirus-Norovirus Combo Test Format (cassette): A4A13011 A4A130125 A4A130140 A4A13021 A4A130225 A4A130240	B IVDR, 98/79	Site web contact@diareagent.com Fiche EUDAMED Signaler une erreur
Gensurebio Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	Candida Albicans/Gardnerella Vaginalis/Trichomonas Vaginalis Ag Rapid Test P203298/79 COVID-19/Flu A+B/RSV/hMPV Ag Rapid Test P209798/79 COVID-19/Flu A+B/RSV/Radv/M.p Ag Rapid Test P209698/79 COVID-19/FluA+B/RSV/Radv/hMPV/M.p Ag Rapid Test P208598/79 COVID-19/FluA+B/RSV/Radv/hMPV/M.p/PIV Ag Rapid Test P208898/79 9 autres COVID-19/FluA+B/RSV/Radv/hMPV/PIV/hRV Ag Rapid Test P208798/79 COVID-19/RSV/Flu A+B Ag Rapid Test P2081C01, P2081C02, P2081C05, P2081C20.3 réf. COVID-19/RSV/Radv/Flu A/B Ag Rapid Test P203998/79 COVID-19/RSV/Radv/hMPV/Flu A+B Ag Rapid Test P208498/79 COVID-19/RSV/Radv/M.P/hMPV/hRV/Flu A+B Ag Rapid Test P208698/79 COVID19/FluA+B/RSV+Radv/hMPV+hRV/PIV/M.p Ag Rapid Test P208998/79 RSV/Radv/Flu A+B Antigen Rapid Test P209098/79 Strep A/COVID-19 Antigen Rapid Test P230398/79 Strep A/COVID-19/Flu A+B Ag Rapid Test P230498/79	C IVDR, 98/79	Site web info@gensurebio.com Fiche EUDAMED Signaler une erreur
Hangzhou Laihe Biotech FDA Mandataire UE : Medunion S.L. (Espagne) et 1 autre	Chine	LYHER 303021901 LYHER 303034701-01;303034701-05;303034701-20;303034701-25;303034701-403 réf. LYHER 3030348013 réf. LYHER 3030419013 réf. LYHER 303045201-01;303045201-05;303045201-20;303045201-25;303045201-403 réf. 7 autres LYHER IRS-582-0198/79 LYHER IRS-582-0298/79 LYHER IRS-582-0598/79 LYHER IRS-582-0798/79 LYHER IRS-582-2098/79 LYHER IRS-582-2598/79 LYHER IRS-582-4098/79	B IVDR, 98/79	Présent sur le marché en France office@lyher.com Fiche EUDAMED Signaler une erreur
Microprofit Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	Respiratory 13 Pathogen Antigen Detection Kit (Colloidal Gold Chromatographic Immunoassay)2 réf.98/79 Respiratory 9 Pathogen Antigen Detection Kit (Colloidal Gold Chromatographic Immunoassay)2 réf.98/79 Respiratory Bacteria & M.P 6 Antigen Combo Test Kit (Immunochromatographic Assay)2 réf.98/79 Respiratory Virus, Bacteria & M.P 10 Antigen Combo Test Kit (Immunochromatographic Assay)2 réf.98/79 Respiratory Virus, Bacteria & M.p 11 Antigen Combo Test Kit (Immunochromatographic Assay)2 réf.98/79 7 autres Respiratory Virus, Bacteria & M.P 14 Antigen Combo Test Kit (Immunochromatographic Assay)2 réf.98/79 SARS-CoV-2 & Influenza A/B & RSV /ADV/hMPV Antigen Combo Test Control98/79 SARS-CoV-2 & Influenza A/B & RSV/ADV/hMPV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)2 réf.98/79 SARS-CoV-2 & Influenza A/B Antigen Combo Test Kit(Colloidal Gold Chromatographic Immunoassay)98/79 SARS-CoV-2/RhV/PIV & Influenza A/B & RSV /ADV/hMPV Antigen Combo Test Control98/79 SARS-CoV-2/RhV/PIV & Influenza A/B & RSV/ADV/hMPV Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)2 réf.98/79 SARS-CoV-2/RhV/PIV/Influenza A/B / RSV/ADV/hMPV/M.P Antigen Combo Test Kit (Colloidal Gold Chromatographic Immunoassay)2 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Reagen Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	COVID-19 & Influenza A/B Antigen Combo Test Kit98/79 Eleven Respiratory Pathogens Antigen Rapid Test Kit 20T98/79 Eleven Respiratory Pathogens Antigen Rapid Test Kit （NPS) 20T98/79 Nine Respiratory Pathogens Antigen Rapid Test Kit 1T98/79 Nine Respiratory Pathogens Antigen Rapid Test Kit 20T98/79 7 autres SARS-CoV-2/RSV&Flu A/B Antigen Rapid Test Kit 1T98/79 SARS-CoV-2/RSV&Flu A/B Antigen Rapid Test Kit 20T98/79 SARS-CoV-2/RSV/ADV/MP&Flu A/B Antigen Rapid Test Kit 1T98/79 SARS-CoV-2/RSV/ADV/MP&Flu A/B Antigen Rapid Test Kit 20T98/79 Ten Respiratory Pathogens Antigen Rapid Test Kit 1T98/79 Ten Respiratory Pathogens Antigen Rapid Test Kit 20T98/79 Twelve Respiratory Pathogens Antigen Rapid Test Kit 1T98/79	– 98/79	Site web info@reagenus.com Fiche EUDAMED Signaler une erreur
Safecare FDA Mandataire UE : Medunion S.L. (Espagne) et 3 autres	Chine	Bacterial Vaginosis Multi-Test Kit98/79 Bacterial Vaginosis Multi-Test(Swab)98/79 COVID-19/Flu/RSV/ADV/hMPV Antigen Combo Rapid Test98/79 COVID-19/Flu/RSV/ADV/hMPV/HPIV Antigen Combo Rapid Test98/79 COVID-19/Flu/RSV/ADV/MP Antigen Combo Rapid Test(Swab)98/79 7 autres COVID-19/FluA&B/RSV/ADV/MP Antigen Combo Rapid Test(Swab)98/79 Mycoplasma pneumoniae IgG/IgM Combo Rapid Test Kit98/79 Mycoplasma pneumoniae(MP) IgG/IgM Combo Rapid Test(Serum/Plasma)98/79 Mycoplasma pneumoniae(MP) IgG/IgM Combo Rapid Test(Whole Blood/Serum/Plasma)98/79 Prueba rápida combinada de antígenos de COVID-19/Gripe/VSR (Hisopo)98/79 Respiratory Pathogens Antigen Combo Rapid Test MID-614298/79 ViraxClear Prueba Rápida Combinada de Antígenos de COVID-19/Gripe/VRS/ADV (Hisopo) COVID-19/Flu A&B/RSV/ADV Antigen Combo Rapid Test98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Phasescientific FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Hong Kong	INDICAID™ Candida/Trichomonas Vaginalis/Gardnerella Vaginalis Rapid Antigen Test98/79 INDICAID™ GASTROINTESTINAL 3-in-1 Rapid Antigen Test98/79 INDICAID™ HPV Virus Staining Test98/79 INDICAID™ Multiple Respiratory Pathogen Rapid Antigen Test98/79 INDICAID™ Respiratory 12-in-1 Rapid Antigen Test98/79 5 autres INDICAID™ Respiratory 12-in-1 Rapid Antigen Test (Children Edition)98/79 INDICAID™ Respiratory 5-in-1 Rapid Antigen Test98/79 INDICAID™ Respiratory 6-in-1 Rapid Antigen Test98/79 INDICAID™ Respiratory 8-in-1 Rapid Antigen Test98/79 INDICAID™ Rotavirus/Adenovirus Rapid Antigen Test98/79	– 98/79	Site web info@phasesci.com Fiche EUDAMED Signaler une erreur
Türklab Tibbi̇ Mlz. San. Ve Ti̇c. Aş	Turquie	Rotavirus Adenovirus Test IRA0198/79 Rotavirus Adenovirus Test RTRA0198/79 Rotavirus Adenovirus Test TIRA0198/79 Rotavirus Adenovirus Test TIRA0100198/79 Rotavirus Adenovirus Test TIRA0101098/79 4 autres Rotavirus Adenovirus Test TRA0198/79 Sars-CoV-2 + Flu A/B + RSV + ADV Test98/79 Sars-CoV-2 + Flu A/B + RSV Test98/79 Sars-CoV-2 + Flu A/B Test98/79	– 98/79	Site web info@turklab.com.tr Fiche EUDAMED Signaler une erreur
Genesignbio Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne) et 1 autre	Chine	1 test/kit7 réf.98/79 25 tests/kit7 réf.98/79 GeneSign Chikungunya Antigen Rapid Test 1 test/kit98/79 GeneSign Chikungunya Antigen Rapid Test 25 tests/kit98/79 GeneSign Chikungunya IgG/IgM Rapid Test 1 test/kit98/79 3 autres GeneSign Chikungunya IgG/IgM Rapid Test 25 tests/kit98/79 GeneSign Dengue NS1/ZIKA/CHIKV Antigen Rapid Test 1 test/kit98/79 GeneSign Dengue NS1/ZIKA/CHIKV Antigen Rapid Test 25 tests/kit98/79	– 98/79	info@genesignbio.com Fiche EUDAMED Signaler une erreur
HangZhou Biotest Biotech FDA Mandataire UE : Shanghai International Holding Corp. GmbH(Europe) (Allemagne)	Chine	RightSign2 réf.98/79 Rightsign ICFR-MC8498/79 Rightsign ICFRA-MC8598/79 Rightsign ICFRAM-MC8698/79 Rightsign ICFRAN-MC8598/79 3 autres Rightsign IRCF-MC8498/79 Rightsign IRCF-MC84S98/79 Rightsign IRCFN-MC8498/79	– 98/79	info@biotests.com.cn Fiche EUDAMED Signaler une erreur
CorDx FDA Mandataire UE : Medunion S.L. (Espagne)	États-Unis	CorDx Respiratory Antigen Combo Rapid Test (ADV/RSV + PIV/HMPV) Cassette CorDx Respiratory Antigen Combo Rapid Test (ADV/RSV) Cassette CorDx Respiratory Antigen Combo Rapid Test (Flu A/B/COVID + ADV/RSV + PIV/HMPV) Cassette CorDx Respiratory Antigen Combo Rapid Test (Flu A/B/COVID + ADV/RSV) Cassette CorDx Respiratory Antigen Combo Rapid Test (Flu A/B/COVID + PIV/HMPV) Cassette 2 autres CorDx Respiratory Antigen Combo Rapid Test (Flu A/B/COVID) Cassette CorDx Respiratory Antigen Combo Rapid Test (PIV/HMPV) Cassette	C IVDR	Fiche EUDAMED Signaler une erreur
Healgen FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	États-Unis	COVID-19+Flu A&B+RSV Ag Combo Rapid Test Cassette (Swab) GCFCR-T525Sa-DD98/79 COVID-19/Flu A&B/RSV Ag Combo Rapid Test Cassette (Swab) GCFCR-T525a98/79 COVID-19/Flu A&B/RSV/Adeno Ag Combo Rapid Test Cassette (Swab) GCFCRA-T525a98/79 COVID-19/Flu A&B/RSV/Adeno Ag Control Kit GCFCRA-PN298/79 COVID-19/Flu A&B/RSV/Adeno/HPIV/HMPV/RhV/M. pneumoniae Ag Combo Rapid Test Cassette (Swab) GCRESA-T555a98/79 2 autres COVID-19/Flu A/Flu B/RSV/ADV/M.P Ag Combo Rapid Test Cassette (Swab) GCFCRAMP-T535a98/79 Flu, COVID-19, RSV & Adeno Ag Combo Test Cassette (Swab) GCFCRA-545a98/79	– 98/79	quality@healgen.com Fiche EUDAMED Signaler une erreur
Bioantibody Biotechnology Mandataire UE : Medunion S.L. (Espagne)	Chine	SARS-CoV-2 & Influenza A/B & RSV & ADV & MP Antigen Combo Rapid Test Kit(Lateral Chromatography) 1 Tests/Kit98/79 SARS-CoV-2 & Influenza A/B & RSV & ADV & MP Antigen Combo Rapid Test Kit(Lateral Chromatography) 25 Tests/Kit98/79 SARS-CoV-2 & Influenza A/B & RSV & ADV & MP Antigen Combo Rapid Test Kit(Lateral Chromatography) 5 Tests/Kit98/79 SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Rapid Test Kit(Lateral Chromatography) 1 Tests/Kit98/79 SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Rapid Test Kit(Lateral Chromatography) 25 Tests/Kit98/79 1 autre SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Rapid Test Kit(Lateral Chromatography) 5 Tests/Kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Bosonbio FDA Mandataire UE : Lotus NL B.V. (Pays-Bas) et 1 autre	Chine	Rapid Flu A+B/RSV Antigen Test Card98/79 Rapid Flu A+B/RSV/ADV Antigen Test Card98/79 Rapid SARS-CoV-2/Flu A+B/RSV Antigen Test Card 1N45C598/79 Rapid SARS-CoV-2/Flu A+B/RSV Antigen Test Card 1N45C5-198/79 Rapid SARS-CoV-2/Flu A+B/RSV/ADV Antigen Test Card 1N44C598/79 1 autre Rapid SARS-CoV-2/Flu A+B/RSV/ADV Antigen Test Card 1N44C5-198/79	– 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Aichek FDA Mandataire UE : Medunion S.L. (Espagne) et 1 autre	Chine	COVID-19/ InfluenzaA+B/RSV Antigen Combo Rapid Test COVID-19/ Influenza A+B/RSV Antigen Combo Rapid Test98/79 COVID-19/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test98/79 COVID-19/Influenza A+B/RSV/Adenovirus/MP Antigen Combo Rapid Test98/79 Rotavirus/Adenovirus Antigen Combo Rapid Test RAV-F22a98/79 Salmonella typhi & Salmonellaparatyphi Antigen Combo Rapid Test98/79	– 98/79	ra.rep@aichek.com Fiche EUDAMED Signaler une erreur
Avioq Bio-tech Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	Chine	1 Test/Kit98/79 20 Tests/Kit98/79 40 Tests/Kit98/79 5 Tests/Kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Fanttest Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	1 test/kit5 réf.98/79 25 tests/kit98/79 50 tests/kit98/79 Cassette(25 tests/kit)98/79	– 98/79	info@fanttest.com Fiche EUDAMED Signaler une erreur
Aconbio Mandataire UE : MedNet EC-REP GmbH (Allemagne)	Chine	FIAflex SARS-CoV-2 & Influenza A/B Ag Combo FIA98/79 Flowflex SARS-CoV-2 & Flu A/B & RSV & Adenovirus Antigen Combo Rapid Test98/79 Flowflex SARS-CoV-2 & Influenza A/B Ag Combo FIA98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Anhui Formaster Biosci Mandataire UE : RIOMAVIX SOCIEDAD LIMITADA (Espagne)	Chine	Influenza A&B/Adeno/RSV/COVID-19 Antigen98/79 Influenza A&B/Adeno/RSV/COVID-19/MP Antigen Rapid Test98/79 Influenza A&B/RSV/COVID-19 Antigen Rapid Test98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Diasia FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	100 Tests/kit2 réf.98/79 25 Tests/kit2 réf.98/79 50 Tests/Kit2 réf.98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
nal von minden	Allemagne	NADAL® Legionella /S. pneumoniae Test98/79 NADAL® Norovirus GI/GII+Rota-Adenovirus Test98/79 NADAL® Rota-Adenovirus Test98/79	– 98/79	Présent sur le marché en France Site web info@nal-vonminden.com Fiche EUDAMED Signaler une erreur
Sejoy FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	ISIRA-944598/79 ISIRAH-965598/79 SARS-CoV-2 & Influenza A/B & Respiratory Syncytial Virus & HMPV Antigen Combo Test Kit98/79	– 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Shenzhen Huian Biosci Technology Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	1T/Kit6 réf.98/79 20T/Kit6 réf.98/79 5T/Kit6 réf.98/79	– 98/79	info@huiantech.com Fiche EUDAMED Signaler une erreur
Vivachek FDA Mandataire UE : CMC Medical Devices & Drugs SL (Espagne) et 1 autre	Chine	Multiplex Respiratory Antigen Rapid Test VIRI3 réf.98/79 Mycoplasma pneumoniae Ag Rapid Test VIMPg98/79 Mycoplasma pneumoniae IgM Rapid Test VIMPb98/79	– 98/79	Présent sur le marché en France info@vivachek.com Fiche EUDAMED Signaler une erreur
Zetmedikal	Turquie	SARS-CoV-2 IgG/IgM Rapid Antibody Test98/79 SOFTEC SARS-CoV-2 Antigen Rapid Test (Nasal Swab)98/79 SOFTEC SARS-CoV-2 Neutralizing Antibody Rapid Test98/79	– 98/79	Site web info@zetmedikal.com Fiche EUDAMED Signaler une erreur
Association Of Medicine Analytics Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Russie	AMA DENT98/79 AMA VENERA98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Azubio Diagnostics Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	Pen A49560H11 Pen A4D660H11	C IVDR	Fiche EUDAMED Signaler une erreur
Biosynex Mandataire UE : BIOSYNEX (France)	France, Suisse	BIOSYNEX COMBO ADENO/ROTA BSS98/79 IMMUNOQUICK NoRotAdeno98/79	– 98/79	Présent sur le marché en France Site web reglementaire@biosynex.com Fiche EUDAMED Signaler une erreur
Diagnostics For Real World FDA Mandataire UE : Medical Technology Promedt Consulting GmbH (Allemagne)	États-Unis	SAMBA III SCoV-2/Flu/RSV Test SAMBA III STI Ulcer Panel Test 7000-12	B, C IVDR	Site web ra@drw-ltd.com Fiche EUDAMED Signaler une erreur
InTec PRODUCTS Mandataire UE : MedNet EC-REP GmbH (Allemagne) et 1 autre	Chine	COVID-19/FluA&B/RSV Ag Combo Rapid Test ITP18260398/79 Rapid Rota-Adenovirus Combo Test ITP1400398/79	– 98/79	Présent sur le marché en France Site web Fiche EUDAMED Signaler une erreur
Jiangsu Macro & Micro-Test Med-Tech FDA Mandataire UE : Medunion S.L. (Espagne)	Chine	COVID-19 /Flu A &B/ RSV/ADV Ag Combo Rapid Test HWTS-RT065A3 réf. RSV/ADV Ag Rapid Test HWTS-RT201A3 réf.	C IVDR	marketing@hongweitest.com Fiche EUDAMED Signaler une erreur
Jiangsu Medomics Medical Technology FDA Mandataire UE : R Sight B.V. (Pays-Bas) et 1 autre	Chine	Candida albicans/ Trichomonas vaginalis/ Gardnerella vaginalis antigen Combo Test Kit (LFIA)98/79 Candida albicans/ Trichomonas vaginalis/ Gardnerella vaginalis antigen Combo Test Kit (LFIA) 012113-01-02；012113-02-02 ；012113-05-02；012113-20-023 réf.	C IVDR, 98/79	Site web info@medomics-dx.com Fiche EUDAMED Signaler une erreur
Neo-nostics (Suzhou) Bioengineering Mandataire UE : Medunion S.L. (Espagne)	Chine	Respiratory Infection Test Device(Nasal/Nasopharyngeal/Oropharyngeal/Serum/plasma/ whole blood) RES024298/79 Vaginitis and Sexually Transmitted Infection Test Device(Urogenital Swab/Serum/plasma/whole blood) VAG024398/79	– 98/79	Fiche EUDAMED Signaler une erreur
Nexlab Mandataire UE : MedNet EC-REP GmbH (Allemagne)	Chine	POCBio COVID-19/FluA/FluB/RSV 4 in 1 Rapid Test LATR05-C2598/79 POCBio Rota/Adenovirus Combo Rapid Test LATG03-C2598/79	– 98/79	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Aaz Productions Le Materiel Biomedical	France	ALL IN QUADRIPLEX®98/79	– 98/79	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Acmexbio Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	Acmex Cassette5 réf.98/79	– 98/79	info@acmexbio.com Fiche EUDAMED Signaler une erreur
BioFynder Mandataire UE : SUNGO Europe B.V. (Pays-Bas)	United Kingdom (ex Northern Ireland)	TruVue98/79	– 98/79	Présent sur le marché en France Fiche EUDAMED Signaler une erreur
Certest	Espagne	CerTest SARS-CoV-2+ Flu A + Flu B + RSV3 réf.	B IVDR	Site web quality@certest.es Fiche EUDAMED Signaler une erreur
Citest Diagnostics Mandataire UE : VidaQuick Biotech S.L. (Espagne)	Canada	Mycoplasma pneumoniae IgM Test Cassette (Whole Blood/Serum/Plasma)98/79	– 98/79	ra02@citestdiagnostics.com Fiche EUDAMED Signaler une erreur
Hightopbio FDA Mandataire UE : MedNet EC-REP GmbH (Allemagne)	Chine	Flu A+B/MP Antigen Rapid Test98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Jiangsu Q-Array Mandataire UE : Caretechion GmbH (Allemagne)	Chine	Adenovirus & Rhinovirus & mycoplasma pneumoniae Nucleic Acid Detection Kit (Fluorescence PCR )5 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Limingbio Mandataire UE : Wellkang Ltd (Irlande du Nord)	Chine	StrongStep® System Device for SARS-CoV-2,Influenza A/B & RSV Combo Antigen Rapid Test 20 Tests/box98/79	– 98/79	Site web sales@limingbio.com Fiche EUDAMED Signaler une erreur
Operon FDA	Espagne	Simple RSV-Flu A+B 9.081.XXX.YY.ZZZ3 réf.	B IVDR	Site web infoeudamed@operon.es Fiche EUDAMED Signaler une erreur
Sekisui Diagnostics FDA Mandataire UE : MDSS GmbH (Allemagne)	États-Unis	OSOM® RSV/Adeno Test 197E98/79	– 98/79	Site web Fiche EUDAMED Signaler une erreur
Shenzhen Lvshiyuan Biotechnology Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	Flu A & Flu B & RSV & COVID-19 Ag Rapid Test Kit (Colloidal Gold) HM003A3	B IVDR	Site web Fiche EUDAMED Signaler une erreur
Wizbiotech Mandataire UE : QbD RepS BV (Belgique)	Chine	Diagnostic Kit for Antigen to Rotavirus/Adenoviruses (Latex)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Zhejiang Greylynx Biotech Mandataire UE : Lotus NL B.V. (Pays-Bas)	Chine	Rota/Adeno Ag Rapid Test GIRA98/79	– 98/79	info@vivachek.com Fiche EUDAMED Signaler une erreur
Zhejiang QL Biotech Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)	Chine	QINGLI Device:20 Test/Kit4 réf.98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Zhejiang Anji Saianfu Biotechnology Mandataire UE : Lotus NL B.V. (Pays-Bas) Aucun modèle encore en vente	Chine	COVID-19 /Flu A&B /RSV /ADENO Ag Combo Rapid Test Cassette (Swab)98/79 (plus commercialisé) COVID-19 /Flu A&B /RSV /ADENO/M.P Ag Combo Rapid Test Cassette (Swab)98/79 (plus commercialisé) COVID-19 /Flu A&B /RSV Ag Combo Rapid Test Cassette (Swab)98/79 (plus commercialisé) TORCH Rapid Test98/79 (plus commercialisé)	– 98/79	Fiche EUDAMED Signaler une erreur

Un modèle enregistré dans EUDAMED n'est pas forcément commercialisé dans votre pays. Vérifiez la disponibilité et le marquage CE auprès du fabricant.

Vous n'avez pas trouvé ?

Décrivez ce que vous cherchez. Les demandes nous indiquent quelles catégories ajouter en priorité.

Vous n'avez pas trouvé ?

Catégories voisines