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Healgen

États-UnisEntités : Healgen Life Science, LLC, Healgen Scientific Limited Liability Company

Premiers pays de mise sur le marché déclarés dans EUDAMED : Allemagne, Autriche, Espagne, Irlande, Turquie

Mandataire UE : CMC Medical Devices & Drugs SL (Espagne)

97 catégories, 290 modèles dont 290 en vente, 1 pays

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93/42 Ancienne directive, pas encore certifié selon le règlement MDR
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Catégorie	Code EMDN	Modèles enregistrés	Classe	Contact
All infectious diseases controls - NAT	W0105080808	AMTBZK01-AHG2E98/79 CAMRZK01-AHG4E98/79 CCDIFZK01-AHG4E98/79 CCNSZK01-AHG4E98/79 CGIBACZK01-AHG4E98/79 10 autres CGIZK01-AHG4E98/79 CHPV14ZK01-AHG4E98/79 CMTBNTMZK01A-AHG4E98/79 CRTI7BZK01-AHG4E98/79 CRTI7CZK01-AHG4E98/79 CSTI6ZK01A-AHG4E98/79 CSTIAZK01-AHG4E98/79 CSTIBZK01-AHG4E98/79 CVAGZK01-AHG4E98/79 CVCBZK01-AHG4E98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Coronavirus antigen (ag) - RT & POC	W0105090501	Coronavirus Ag Rapid Test Cassette (Swab) GCCOV-502a98/79 Coronavirus Ag Rapid Test Cassette (Swab) GCCOV-502a-NA98/79 Coronavirus Ag Rapid Test Cassette (Swab) GCCOV-502a-NN98/79 COVID-19 Ag & B.1.1.7 Mutant Strain Combo Test Cassette (Swab) GCCOV(B117)-525a98/79 COVID-19 Ag Rapid Test Cassette (Oral Fluid) GCCOV-702a98/79 5 autres Digital COVID-19 Ag Rapid Test (Swab) GCCOV-D503a98/79 Rapid COVID-19 Antigen Test Strip GCCOV-501a98/79 SARS-CoV-2 Ag Fluorescence Rapid Test Cassette (Swab) FCCOV-502a98/79 SARS-CoV-2 Delta-series Mutant Strain Ag Rapid Test Cassette (Swab) GCCOV(Del)-T502a98/79 Smart Rapid COVID-19 Ag Test Device GCCOV-503a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
H. pylori - RT & POC	W0105090102	H. pylori Ab Rapid Test Cassette (Serum/Plasma) GCHP-302a98/79 H. pylori Ab Rapid Test Cassette (Whole blood/Serum/Plasma) GCHP-402a98/79 H. pylori Ag Rapid Test Cassette (Feces) GCHP-602a98/79 H. pylori Ag Rapid Test Cassette (Feces) GCHP-602Ca98/79 H. pylori Ag Rapid Test Strip (Feces) GCHP-601a98/79 4 autres H. pylori Ag Rapid Test Strip (Feces) GCHP-601Ca98/79 H.pylori Ag Rapid Test Device (Feces) GCHP-606a98/79 H. pylori Ab Rapid Test Strip (Serum/Plasma) GCHP-301a98/79 H. pylori Ab Rapid Test Strip (Whole blood/Serum/Plasma) GCHP-401a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents	W0105070304	101A0227EY98/79 ACAB01-AHG48E; ACAB01-AHG96E98/79 ACAB04D-BHG48E98/79 ACOV01-AHG48E; ACOV01-AHG96E98/79 ACOV03-AHG48E; ACOV03-AHG96E; ACOV03D-AHG48E; ACOV03D-AHG96E98/79 4 autres ACOV03D-AHG48E; ACOV03D-AHG96E98/79 AFR01-AHG48E; AFR01-AHG96E; AFR01D-AHG48E; AFR01D-AHG96E98/79 CRTI7A01A-AHG4E98/79 CRTI7B01A-AHG4E98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Influenza a and /or b - RT & POC	W0105099004	AFAB01-AHG48E; AFAB01-AHG96E98/79 AFAB03-AHG48E; AFAB03-AHG96E; AFAB03D-AHG48E; AFAB03D-AHG96E98/79 AFAB03D-AHG48E; AFAB03D-AHG96E98/79 AIAH501D-AHG48E; AIAH501D-AHG96E98/79 Flu A Ag Rapid Test Cassette (Swab) GCFLU(A)-U502a98/79 4 autres Influenza A & B Ag Rapid Test Cassette (Swab) GCFLU(A/B)-502a98/79 Influenza A & B Ag Rapid Test Cassette (Swab) GCFLU(A/B)-502Ca98/79 Influenza A & B Ag Rapid Test Strip (Swab) GCFLU(A/B)-501a98/79 Influenza A (H5) Ag Rapid Test Cassette (Swab) GCFLU(AH5)-502a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Virology - RT & POC - other	W0105099099	COVID-19 /Flu A&B /RSV Ag Combo Rapid Test Cassette (Swab) GCFCR-T525a-NN98/79 Rapid COVID-19 Antigen Self-Test GCCOV-502a-H198/79 Rapid COVID-19 Antigen Self-Test GCCOV-502a-H1098/79 Rapid COVID-19 Antigen Self-Test GCCOV-502a-H1598/79 Rapid COVID-19 Antigen Self-Test GCCOV-502a-H298/79 4 autres Rapid COVID-19 Antigen Self-Test GCCOV-502a-H2098/79 Rapid COVID-19 Antigen Self-Test GCCOV-502a-H398/79 Rapid COVID-19 Antigen Self-Test GCCOV-502a-H598/79 Rapid COVID-19 Antigen Self-Test GCCOV-502a-H798/79	– 98/79	Fiche EUDAMED Signaler une erreur
Reagents for DNA and/or RNA amplification and/or detection: bacteria and/or virus	W0105900102	"AHTV01-AHG48E， AHTV01-AHG96E"98/79 ADZCOM01D-AHG48E98/79 AHTV01D-AHG48E98/79 CMTB01A-AHG4E98/79 CMTBMDR01A-AHG4E98/79 3 autres CMTBMDRZK01-AHG4E98/79 CMTBRIF01A-AHG4E98/79 CMTBRIFZK01-AHG4E98/79	– 98/79	Fiche EUDAMED Signaler une erreur
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents	W0105070501	CGCT01A-AHG4E98/79 CGTUC01A-AHG4E98/79 CNCMT01A-AHG4E98/79 CSTD601A-AHG4E98/79 CSTI7A01A-AHG4E98/79 3 autres CSTI7B01A-AHG4E98/79 CSTIZK01A-AHG4E98/79 Nucleic Acid Detection Kit for Reproductive Tract Infection Pathogens (9 Types)(Flowcytometry Fluorescence Hybridization Method)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Various rapid test chemistry / immunochemistry instruments - other	W0201069099	Hand-Held Immunofluorescence OG-G300 Immunofluorescence Analyzer OG-G200 Immunofluorescence Analyzer OG-H180 Mini Immunofluorescence Analyzer OG-H100 Mini Immunofluorescence Analyzer OG-H101 3 autres Multi-channel Immunofluorescence Analyzer OG-G260C Multiplex Fluorescent Analyzer OG-G260 Urine Drug Test Cup Reader OG-D600	A IVDR	Fiche EUDAMED Signaler une erreur
Dengue - RT & POC	W0105099007	CDGV01A-AHG4E98/79 CDGVZK01-AHG4E98/79 Dengue IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCDEN(ab)-402e98/79 Dengue IgM/IgG Rapid Test Cassette (Whole Blood/Serum/Plasma) GCDEN(ab)-402c98/79 Dengue NS1 Ag Rapid Test Cassette (Whole Blood/Serum/Plasma) GCDEN(NS)-402c98/79 2 autres Dengue NS1 Ag Rapid Test Cassette(Whole Blood/Serum/Plasma) GCDEN(NS)-402d98/79 Dengue NS1+IgM/IgG Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) GCDEN-425a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Other multiple pathogens - RT & POC	W0105090699	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	Fiche EUDAMED Signaler une erreur
Adenovirus	W0105040601	Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab) FCADE-502a98/79 Adenovirus Antigen Fluorescence Rapid Test Cassette (Swab) FCADE-502Ca98/79 Adenovirus Antigen Rapid Test Cassette (Swab) GCADE-502a98/79 Adenovirus Antigen Rapid Test Cassette (Swab) GCADE-502Ca98/79 Adenovirus Rapid Test Cassette (Feces) GCADE-602a98/79 1 autre Adenovirus Rapid Test Cassette (Feces) GCADE-602Ca98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Plasmodium (malaria) - RT & POC	W0105090401	Malaria P.f./P.v. Ag Rapid Test Cassette (Whole Blood) GCMAL(pf/pv)-402a98/79 Malaria P.f./Pan Ag Rapid Test Cassette (Whole Blood) GCMAL(pf/pan)-402a98/79 Malaria Pan Ag Rapid Test Cassette (Whole Blood) GCMAL(pan)-402a98/79 Malaria Pf Ag Rapid Test Cassette (Whole Blood) GCMAL(Pf)-402a98/79 Malaria Pf/Pv Ab Rapid Test Cassette (Serum/Plasma) GCMAL(pf/pv Ab)-302a98/79 1 autre Malaria Pf/Pv Ab Rapid Test Cassette (whole blood/serum/plasma) GCMAL(pf/pv Ab)-402a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Strep. a - RT & POC	W0105090103	Strep A Rapid Test Cassette (Throat Swab) GCSTR-502a98/79 Strep A Rapid Test Cassette (Throat Swab) GCSTR-502Ca98/79 Strep A Rapid Test Cassette (Throat Swab) GCSTR-502CSa98/79 Strep A Rapid Test Strip (Throat Swab) GCSTR-501a98/79 Strep A Rapid Test Strip (Throat Swab) GCSTR-501Ca98/79 1 autre Strep A Rapid Test Strip (Throat Swab) GCSTR-501CSa98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Chikungunya virus	W0105040625	Chikungunya IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma) GCCHK(IgG/IgM)-402b98/79 Chikungunya IgM Rapid Test Cassette (Serum/Plasma) GCCHK(IgM)-302a98/79 Chikungunya IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCHK(IgM)-402a98/79 Chikungunya IgM/IgG Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCHK(IgM/IgG)-402a98/79 One Step Chikungunya Ag Test Cassette (Whole Blood/Serum/Plasma) GCCHK-402a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Controls infectious immunology - RT & POC	W0105094001	COVID-19 Antigen Control Kit GCCOV(Ag)-PN1098/79 COVID-19 Antigen Control Kit GCCOV(Ag)-PN2098/79 COVID-19 IgG/IgM CONTROL Kit GCCOV-PN1098/79 COVID-19 IgG/IgM CONTROL Kit GCCOV-PN2098/79 H. pylori Ag Control Kit GCHP-PN298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Multiple viruses - multiplex assays - other	W0105070399	Flu A&B/RSV Ag Combo Rapid Test Cassette (Swab) GCFR-T502a98/79 Flu A/RSV Ag Combo Rapid Test Cassette (Swab) GCFR(A)-T502a98/79 Influenza A&B Ag Test Kit (Time-Resolved FIA) FCFLU(A/B)-502Fa98/79 RSV/Adenovirus Antigen Combo Fluorescence Rapid Test Cassette (Swab) FCRA-T502a98/79 SARS-CoV-2 + Flu A&B Ag Test Kit (Time-Resolved FIA) FCFC-T502a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Other virology controls - inf.imm.	W0105080804	Adenovirus Antigen Control Kit GCADE-PN298/79 Adenovirus Antigen FIA Control Kit FCADE-PN298/79 RSV Antigen Control Kit GCRSV-PN1098/79 RSV Antigen Control Kit GCRSV-PN298/79 RSV Antigen FIA Control Kit FCRSV-PN298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Influenza & para influenza	W0105040604	APA01-AHG48E; APA01-AHG96E; APA01D-AHG48E; APA01D-AHG96E98/79 Flu A Ag Fluorescent Rapid Test Cassette (Time-Resolved FIA) FCFLU(A)-502a98/79 Flu A(H5) Ag Fluorescent Rapid Test Cassette (Time-Resolved FIA) FCFLU(AH5)-502a98/79 HPIV Antigen Rapid Test Kit (Time-Resolved FIA) FCHPIV-502a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Mycobacterial detection by NA reagents	W0105010703	AMTBC01-AHG48E; AMTBC01-AHG96E; AMTBC01D-AHG48E; AMTBC01D-AHG96E98/79 AMTBC01D-AHG48E, AMTBC01D-AHG96E98/79 CMTBNTM01A-AHG4E98/79 RMTB01-AHG5E, RMTB01-AHG25E98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Other HPV - NA reagents	W0105041005	AHPV1801-AHG48E98/79 Nucleic Acid Genotyping Kit for Human Papillomavirus 29 types(Flowcytometry Fluorescence Hybridization Method)98/79 RHPV201-AHG5E/RHPV201-AHG25E98/79 RHPV301-AHG5E/RHPV301-AHG25E98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Other multiple infectious - multiplex NA reagents	W0105070502	CFFCR01A-AHG4E98/79 CRTI601A-AHG4E98/79 CRTI701A-AHG4E98/79 CVAG01A-AHG4E98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Partial genotyping high-risk HPV - NA reagents	W0105041003	AHPV1401-AHG48E98/79 AHPV1401D-AHG48E98/79 CHPV1402A-AHG4E98/79 Nucleic Acid Genotyping Kit for Human Papillomavirus 18 types (Flowcytometry Fluorescence Hybridization Method)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	SCLS01-AHG10E98/79 SNCE01-AHG48/ SNCE01-AHG96/ SNCE02-AHG16/ SNCE02-AHG48/ SNCE02-AHG9698/79 SNCE05-AHG48E98/79 SNCE07-AHG50E98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Syphilis - RT & POC	W0105090105	Syphilis Ab Rapid Test Cassette (Serum/Plasma) GCSYP-302a98/79 Syphilis Ab Rapid Test Cassette (Whole Blood/Serum/Plasma) GCSYP-402a98/79 Syphilis Ab Rapid Test Strip (Serum/Plasma) GCSYP-301a98/79 Syphilis Ab Rapid Test Strip (Whole Blood/Serum/Plasma) GCSYP-401a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Clost. diff. incl GDH and/or toxin a and b - RT & POC	W0105090106	Clostridium difficile Antigen GDH Rapid Test Cassette (Feces) GCCD(GDH)-602a98/79 Clostridium difficile GDH & Toxin A/B Rapid Test Cassette (Feces) GCCD-602a98/79 Clostridium difficile Toxin A&B Rapid Test Cassette (Feces) GCCD(Toxin A/B)-602a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Coronavirus / influenza - RT & POC	W0105090601	COVID-19/Flu A&B Ag Combo Rapid Test Cassette (Swab) GCFC-T502a98/79 Rapid COVID-19+Influenza Antigen Test GCFC-525a98/79 Smart Rapid COVID-19 & Flu A/B Ag Test Device GCFC-T503a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Coronavirus antibody (ab) - RT & POC	W0105090502	COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCOV-402a98/79 COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCOV-402Ba98/79 SARS-CoV-2 Neutralizing Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCOV(NAb)-402b98/79	– 98/79	Fiche EUDAMED Signaler une erreur
D-dimer	W0103020503	D-Dimer Quantitative Test Kit (Time-Resolved FIA) FDDDI-402a98/79 D-Dimer Rapid Test Cassette (Whole Blood/Plasma) GDDDI-402b98/79 D-Dimer Test Kit (CLIA)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Full genotyping high-risk + low-risk HPV - NA reagents	W0105041004	AHPV1801-BHG48E,AHPV1801-BHG96E98/79 AHPV2301-AHG48E98/79 AHPV2301D-AHG48E98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Gonococcal detection by NA reagents	W0105010203	ANG01-AHG48E; ANG01-AHG96E; ANG01D-AHG48E; ANG01D-AHG96E98/79 ANG01D-AHG48E; ANG01D-AHG96E98/79 RVZV01-AHG5E/RVZV01-AHG25E98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hsv - NA reagents	W0105040311	AHSV101-AHG48E; AHSV101-AHG96E; AHSV101D-AHG48E; AHSV101D-AHG96E98/79 AHSV201-AHG48E; AHSV201-AHG96E; AHSV201D-AHG48E; AHSV201D-AHG96E98/79 AHSV201D-AHG48E; AHSV201D-AHG96E98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Leishmania	W0105050205	Leishmania Ab Rapid Test Cassette (Whole Blood/Serum/Plasma) GCKal-402a98/79 Leishmania Ab Rapid Test Strip (Whole Blood/Serum/Plasma) GCKal-401a98/79 Leishmania IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCKal-T402a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Mononucleosis (ebv) - RT & POC	W0105099003	Mononucleosis IgG/IgM Rapid Test Cassette (Whole blood/Serum/Plasma) GCMON-425a98/79 Mononucleosis IgG/lgM Rapid Test Cassette(Serum/Plasma) GCMON-325a98/79 Mononucleosis Rapid Test Cassette (Whole Blood/Serum/Plasma) GCMON-402a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Samples analyses, plastic microtubes - accessories	W050301020280	SDCSM01-AHG50E98/79 SDSM01-AHG50E98/79 SDVS01-AHG50E/SDVS01-BHG50E SDVS01-CHG50E/SDVS01-DHG50E98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Zika virus	W0105040630	Zika IgG Rapid Test Cassette (Whole Blood/Serum/Plasma) GCZIK(IgG)-402b98/79 Zika IgG/IgM Rapid Test Cassette(Whole Blood/Serum/Plasma) GCZIK(IgG/IgM)-T402a98/79 Zika NS1 Ag Rapid Test Cassette(Whole blood/Serum/Plasma) GCZIK(NS1)-402a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Bacteriology immunoassay - other	W0105011799	V. cholerae O1 Ag Rapid Test Cassette (Feces) GCVCH(O1)-602a98/79 V. cholerae O1/O139 Ag Rapid Test Cassette (Feces) GCVCH(O1/O9)-602a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Brucella	W0105011701	Brucella Antibody Rapid Test Cassette (Whole Blood/Serum/Plasma) GCBRU-402a98/79 Brucella IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCBRU(IgG/IgM)-402a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Chagas	W0105050202	Chagas Ab Rapid Test Cassette (Serum/Plasma) GCCHA-302a98/79 Chagas Ab Rapid Test Cassette (Whole Blood/Serum/Plasma) GCCHA-402a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Dengue virus - NA reagents	W0105040511	ADV01-AHG48E; ADV01-AHG96E; ADV01D-AHG48E; ADV01D-AHG96E98/79 ADV01D-AHG48E; ADV01D-AHG96E98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Ebv - NA reagents	W0105040403	AEBV01-AHG48E; AEBV01D-AHG48E98/79 AEBV01D-AHG48E98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Enterovirus	W0105040602	EV71 IgM Rapid Test Cassette (Serum/Plasma) GCEV71(IgM)-302a98/79 EV71 IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCEV71(IgM)-402a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Gastrointestinal infections - multiplex NA reagents	W0105070504	CGI601A-AHG4E98/79 CGIBAC01A-AHG4E98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Gonococcal antigen detection	W0105010201	Gonorrhea Rapid Test Cassette (Swab) GCGON-502b98/79 Healgen® Gonorrhoea Fluorescent Rapid Test FCGON-502a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hantavirus / bunyavirus	W0105040614	Hantavirus IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCHV(IgG/IgM)-402a98/79 Hantavirus IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCHV(IgM)-402a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hav antibody (total)	W0105020102	HAV IgG/IgM Rapid Test Cassette (Serum/Plasma) GCHAV(IgG/IgM)-302a98/79 HAV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCHAV(IgG/IgM)-402a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
HCV antibody -RT & POC	W0105090202	HCV Hepatitis C Virus Rapid Test (Serum/Plasma)(Cassette) GCHCV-302a98/79 HCV Hepatitis C Virus Rapid Test (Serum/Plasma)(Cassette) GCHCV-402a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
HIV 1 / 2 - RT & POC	W0105090302	HIV 1/2 Human Immunodeficiency Virus Rapid Test (Serum/Plasma)(Cassette) GCHIV-302a98/79 HIV 1/2 Human Immunodeficiency Virus Rapid Test st (Whole blood/Serum/Plasma)(Cassette) GCHIV-402a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hsv 1+2 igg	W0105040303	HSV IgG Rapid Test Cassette (Serum/Plasma) GCHSV(IgG)-302a98/79 HSV IgG Rapid Test Cassette (Whole blood/Serum/Plasma) GCHSV(IgG)-402a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hsv 1+2 igm	W0105040304	HSV IgM Rapid Test Cassette (Serum/Plasma) GCHSV(IgM)-302a98/79 HSV IgM Rapid Test Cassette (Whole blood/Serum/Plasma) GCHSV(IgM)-402a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Interleukin 6 (il-6)	W01030609	IL-6 Quantitative Test Kit (Time-Resolved FIA)98/79 Interleukin 6 Test Kit (CLIA)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Monkeypox virus / mpox - NA reagent	W0105040532	AMPV01-AHG48E; AMPV01-AHG96E98/79 AMPV01D-AHG48E; AMPV01D-AHG96E98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Monkeypox virus / mpox RT & POC	W0105099008	Monkeypox Ag Rapid Test Cassette (Swab) GCMKP-502b98/79 Monkeypox IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCMKP-402a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Multiple infectious - multiplex assays - other	W0105070599	FOB/Transferrin/Adeno/Rota/H. pylori Combo Rapid Test Device (Feces) GEFTHRA-T636a98/79 FOB/Transferrin/H.pylori Combo Rapid Test Device (Feces) GEFTH-T625a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Mycobacterial antibody assays	W0105010702	Tuberculosis IgG/IgM Rapid Test Cassette (Serum/Plasma) GCTB-302a98/79 Tuberculosis IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCTB-402a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Nucleic acid testing instruments except micro-arrays - hardware accessories	W02050180	MRQP06-E98/79 PSR-MRQP0498/79	– 98/79	Fiche EUDAMED Signaler une erreur
Respiratory syncytial virus (rsv)	W0105040605	RSV Antigen Fluorescence Rapid Test Cassette (Swab) FCRSV-502Ca98/79 RSV Antigen Fluorescent Rapid Test Cassette (Swab) FCRSV-502a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Respiratory tract infections - multiplex NA reagents	W0105070503	CRTI7C01A-AHG4E98/79 Nucleic Acid Detection Kit for Respiratory Tract Infection Pathogens (8 Types)(Flowcytometry Fluorescence Hybridization Method)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Rotavirus	W0105040606	Rotavirus Rapid Test Cassette (Feces) GCROA-602a98/79 Rotavirus Rapid Test Cassette (Feces) GCROA-602Ca98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Rsv - RT & POC	W0105099002	RSV Antigen Rapid Test Cassette (Swab) GCRSV-502a98/79 RSV Antigen Rapid Test Cassette (Swab) GCRSV-502Ca98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Salmonella antibody assays	W0105011002	Typhoid IgG/IgM Rapid Test Cassette (Serum/Plasma) GCTYP-302a98/79 Typhoid IgG/IgM Rapid Test Cassette (Serum/Plasma) GCTYP-302b98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Screening high-risk HPV - NA reagents	W0105041002	AHPV1801-CHG48E98/79 CHPV1401A-AHG4E98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Strep. a detection by NA reagents	W0105011103	AGAS01-AHG48E; AGAS01D-AHG48E98/79 RGAS01-AHG5E/ RGAS01-AHG25E98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Streptococcal detection by NA reagents	W0105011102	CGBS01A-AHG4E98/79 CGBSZK01A-AHG4E98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Syphilis detection by NA reagents	W0105010305	ATP01-AHG48E/ATP01-AHG96E/ATP01D-AHG48E/ATP01D-AHG96E98/79 ATP01D-AHG48E/ATP01D-AHG96E98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Tropical fever - multiplex NA reagents	W0105070506	CVCB601A-AHG4E98/79 CVCB801A-AHG4E98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Ureaplasma detection by NA reagents	W010501080303	AMP01-AHG48E; AMP01-AHG96E; AMP01D-AHG48E; AMP01D-AHG96E98/79 AMP01D-AHG48E; AMP01D-AHG96E98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Bacteriology controls - inf.imm.	W0105080801	Strep A Antigen Control Kit GCSTR-PN298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Bordetella pertussis / parapertussis - NA reagents	W0105011607	ABPTS02-AHG48E/ ABPTS02-AHG96E98/79	– 98/79	Fiche EUDAMED Signaler une erreur
C.difficile by NA reagents	W0105011804	CCDIF01A-AHG4E98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Candida albicans	W0105060302	Candida albicans Antigen Rapid Test Cassette (Swab) GCCA-502a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Cryptococcus	W0105060303	Cryptococcal Ag Rapid Test Cassette (Whole Blood/Serum/Plasma/Cerebral Spinal Fluid) GCCr(Ag)-402a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Flow cytometry instruments - other	W02020499	Mplex-M1002 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Giardia lamblia	W0105050208	Giardia lamblia Antigen Rapid Test Cassette (Feces) GCGIA-602a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hav reagents - other	W0105020199	HAV Ag Rapid Test Cassette (Feces) GCHAV-602a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hemostasis controls RT & POC	W010302080501	D-Dimer Control FDDDI-PN2098/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hev antibody igm	W0105020505	HEV IgM Rapid Test Cassette (Serum/Plasma) GCHEV-302a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Histology / cytology reagents - other	W01030799	SCPS01-AHG50E98/79	– 98/79	Fiche EUDAMED Signaler une erreur
HPV antigen / antibodies	W0105041001	Human Papillomavirus E7 Protein Rapid Test Cassette (Swab) GCHPV-502a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Human metapneumovirus	W0105040617	Human Metapneumovirus (HMPV) Ag Rapid Test GCHMPV-502a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Leptospira	W0105011704	Leptospira IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) GCLEP(IgG/IgM)-402a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Limited panel immunochemistry analysers - other	W0201020299	CLIA-go Pro Chemiluminescence Immunoassay Analyzer Lumini-C100	A IVDR	Fiche EUDAMED Signaler une erreur
Lymphokines /immunmodulators - other	W01030699	Quantitative Analysis Kit for Six Cytokines (Flowcytometry Fluorescence Method)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Meningitis / encephalitis infections - multiplex NA reagents	W0105070505	CCNS801A-AHG4E98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Multiconstituent controls - inf.imm.	W0105080807	Rotavirus and Adenovirus Antigen Control Kit GCROA/ADE-PN298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Mycoplasma antibody assays	W0105010802	M. pneumonia IgM Rapid Test Cassette (Serum/Plasma) GCMP(IgM)-302a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Mycoplasma antigen detection	W0105010801	M. pneumoniae Ag Rapid Test Cassette (Swab) GCMP-502a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Norovirus	W0105040616	Norovirus Antigen Rapid Test Cassette (Feces) GCNOR-602a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Nucleic acid testing apparatuses - rapid and point of care tests	W02050301	MFIA02-E98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Nucleic acid testing integrated extraction /amplification /detection systems	W02050116	MNAP0198/79	– 98/79	Fiche EUDAMED Signaler une erreur
Salmonella antigen detection	W0105011001	S. typhi Ag Rapid Test Cassette (Serum/Plasma/Feces) GCSAL(ST)-602a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Samples collection devices - other	W05019099	SMTB01-AHG5E ,SMTB01-AHG25E, SMTB01-BHG5E, SMTB01-BHG25E98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Tb-igra (interferon-gamma-release assay)	W0105010704	Tuberculosis Interferon-Gamma Release Assay Test Kit (CLIA)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Trichomonas	W0105050210	Trichomonas Ag Rapid Test Cassette (Swab) GCTV-502a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Varicella zoster - NA reagents	W0105040904	RVZV01-AHG5E98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Viral antigen/antibody detection - other	W0105040699	Rotavirus and Adenovirus Combo Rapid Test Cassette (Feces) GCROA/ADE-602a98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Virology - NA reagents - other	W0105040599	CRTIZK01-AHG4E98/79	– 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.

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