Fabricant

Kangsheng Information Technology (Hangzhou)

ChineEntités : Kangsheng Information Technology (Hangzhou) Co. LTD

Marchés : Allemagne

Mandataire UE : Crealkraft GmbH (Allemagne)

49 catégories, 124 modèles dont 124 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
Virology - NA reagents - other	W0105040599	Adenovirus (Respiratory Type) Nucleic Acid Detection Kit Nc02998/79 Bocavirus Nucleic Acid Detection Kit Nc03498/79 Chikungunya Virus Nucleic Acid Detection Kit Nc02498/79 Dengue Virus Nucleic Acid Detection Kit Nc00898/79 Human Metapneumovirus Nucleic Acid Detection Kit (Fluorescence)98/79 22 autres Human Metapneumovirus Nucleic Acid Detection Kit Nc03098/79 Influenza A/B Virus Nucleic Acid Detection Kit Nc01798/79 Japanese Encephalitis Virus Nucleic Acid Detection Kit98/79 Japanese Encephalitis Virus Nucleic Acid Detection Kit (Fluorescence)98/79 Measles Virus Nucleic Acid Detection Kit (Fluorescence)98/79 Measles Virus Nucleic Acid Detection Kit Nc00698/79 Monkeypox Virus Nucleic Acid Detection Kit Nc00998/79 Nc00298/79 Nipah Virus Nucleic Acid Detection Kit (Fluorescence)98/79 Nipah Virus Nucleic Acid Detection Kit (Nasopharyngeal Swab)98/79 Norovirus Nucleic Acid Detection Kit (Fluorescence)98/79 Norovirus Nucleic Acid Detection Kit Nc01898/79 Oropouche Virus Nucleic Acid Detection Kit98/79 Oropouche Virus Nucleic Acid Detection Kit (Fluorescence)98/79 Parainfluenza Virus (I-IV) Nucleic Acid Detection Kit98/79 Plasmodium Nucleic Acid Detection Kit Nc01698/79 Poliovirus Nucleic Acid Detection Kit (Fluorescence)98/79 Respiratory Syncytial Virus (A/B) Nucleic Acid Detection Kit Nc02898/79 Rhinovirus Nucleic Acid Detection Kit (Nasopharyngeal Swab) Nc03398/79 West Nile Virus Nucleic Acid Detection Kit Nc02298/79 Yellow Fever Virus Nucleic Acid Detection Kit (Fluorescence)98/79 Zika Virus Nucleic Acid Detection Kit Nc02398/79	– 98/79	Fiche EUDAMED Signaler une erreur
Brucella - NA reagents	W0105011601	Bordetella pertussis Nucleic Acid Detection Kit (Unvaccinated)98/79 Bordetella pertussis Nucleic Acid Detection Kit Nc01498/79 Corynebacterium diphtheriae Nucleic Acid Detection Kit98/79 Enterohemorrhagic Escherichia coli Nucleic Acid Detection Kit98/79 Haemophilus influenzae Nucleic Acid Detection Kit Nc04098/79 4 autres Klebsiella pneumoniae Nucleic Acid Detection Kit98/79 Neisseria meningitidis Nucleic Acid Detection Kit Nc01398/79 Vibrio cholerae Nucleic Acid Detection Kit (Fluorescence)98/79 Vibrio parahaemolyticus Nucleic Acid Detection Kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Bacteriology - RT & POC - other	W0105090199	Bordetella Pertussis (BP) Antigen Detection Kit98/79 Candidiasis Antigen Test Kit98/79 Gardneralla Vaginalis Rapid Test98/79 Neisseria gonorrhoeae Antigen Test Kit Ir01998/79 Salmonella Typhi Ag Test Kit98/79 2 autres Treponema pallidum Antibody Test Kit Ir01698/79 Typhoid Ab IgM/IgG Test Kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Bacteriology - NA reagents - other	W0105011699	Corynebacterium diphtheriae Nucleic Acid Detection Kit (Fluorescence)98/79 Enterohemorrhagic Escherichia coli Nucleic Acid Detection Kit (Fluorescence)98/79 Klebsiella pneumoniae Nucleic Acid Detection Kit (Fluorescence)98/79 Nc00198/79 Vibrio parahaemolyticus Nucleic Acid Detection Kit (Fluorescence)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Prothrombin time ( quick test )	W0103020101	APTT Activated Partial Thromboplastin Time Test Kit98/79 FIB Fibrinogen Test Kit98/79 PT Prothrombin Time Test Kit98/79 PT/APTT Test Panel98/79 TT Thrombin Time Test Kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Coronavirus ag	W0105041101	Human Coronavirus (OC43/229E/HKU1/NL63) Nucleic Acid Detection Kit98/79 Human Coronavirus (OC43/229E/HKU1/NL63) Nucleic Acid Detection Kit (Fluorescence)98/79 SARS-CoV-2 Nucleic Acid Detection Kit2 réf.98/79 SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Salmonella antigen detection	W0105011001	Group A Streptococcus Nucleic Acid Detection Kit98/79 Mycobacterium tuberculosis Nucleic Acid Detection Kit98/79 Salmonella typhi/paratyphi Nucleic Acid Detection Kit98/79 Streptococcus pneumoniae Nucleic Acid Detection Kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Cmv - RT & POC	W0105099001	COVID-19 (2019n-Cov) Antigen Detection Kit98/79 HSV Herpes Simplex Virus Ab Test Kit Ir05998/79 Rotavirus Ag Test Kit Ir03498/79	– 98/79	Fiche EUDAMED Signaler une erreur
Dengue - RT & POC	W0105099007	Dengue Ab IgM/IgG Test Kit Ir02698/79 Dengue Ag NS1 Test Kit98/79 Dengue NS1/IgM/IgG Test Panel98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Dengue virus - NA reagents	W0105040511	Dengue Virus Genotyping Nucleic Acid Detection Kit (Fluorescence)98/79 Dengue Virus Genotyping Nucleic Acid Detection Kit Nc04798/79 Dengue Virus Nucleic Acid Detection Kit (Fluorescence)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Adenovirus - NA reagents	W0105040501	Adenovirus (Respiratory Type) Nucleic Acid Detection Kit (Fluorescence)98/79 Measles Virus Nucleic Acid Detection Kit Nc00698/79	– 98/79	Fiche EUDAMED Signaler une erreur
Aspergillus - NA reagents	W0105060401	Aspergillus Nucleic Acid Detection Kit (Fluorescence, Sputum/BALF)98/79 Aspergillus Nucleic Acid Detection Kit (Sputum/BALF)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Bordetella pertussis / parapertussis - NA reagents	W0105011607	Bordetella pertussis Nucleic Acid Detection Kit (Fluorescence)98/79 Bordetella pertussis Nucleic Acid Detection Kit (Fluorescence, Unvaccinated)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Chlamydia ag - RT & POC	W0105090101	Cholera Ag Rapid Test Kit98/79 Mycoplasma Pneumoniae Ab Test Kit Ir04798/79	– 98/79	Fiche EUDAMED Signaler une erreur
Cryptococcus - NA reagents	W0105060403	Cryptococcus Nucleic Acid Detection Kit (CSF) Nc04498/79 Cryptococcus Nucleic Acid Detection Kit (Fluorescence, CSF)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Enterovirus - NA reagents	W0105040502	Enterovirus (Non-Poliovirus) Nucleic Acid Detection Kit98/79 Enterovirus (Non-Poliovirus) Nucleic Acid Detection Kit (Fluorescence)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Gram+ - gram- - fungi - multiplex NA reagents	W0105070201	Shigella/Entamoeba histolytica Nucleic Acid Detection Kit (Fluorescence)98/79 Shigella/Entamoeba histolytica Nucleic Acid Detection Kit Nc01098/79	– 98/79	Fiche EUDAMED Signaler une erreur
H. pylori - RT & POC	W0105090102	H.Pylori Ab Test Kit Ir03098/79 H.Pylori Ag Test Kit Ir03198/79	– 98/79	Fiche EUDAMED Signaler une erreur
Hepatitis viruses - RT & POC - other	W0105090299	Hepatitis A Virus IgM Antibody Test Kit Ir00498/79 Hepatitis E Virus IgM Antibody Test Kit Ir01298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Mycobacteria reagents - other	W0105010799	Non-tuberculous Mycobacterium Nucleic Acid Detection Kit98/79 Non-tuberculous Mycobacterium Nucleic Acid Detection Kit (Fluorescence)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Other coronavirus reagents	W0105041199	SARS-CoV-2 Nucleic Acid Detection Kit98/79 SARS-CoV-2 Nucleic Acid Detection Kit (Fluorescence Screening)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Parasites - RT & POC - other	W0105090499	Malaria Ag Test Kit Ir02898/79 Trichomoniasis Rapid Test98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Pneumocystis - NA reagents	W0105060405	Pneumocystis jirovecii Nucleic Acid Detection Kit (Fluorescence, BALF)98/79 Pneumocystis jirovecii Nucleic Acid Detection Kit Nc04598/79	– 98/79	Fiche EUDAMED Signaler une erreur
Salmonella detection by NA reagents	W0105011003	Mycobacterium tuberculosis Nucleic Acid Detection Kit (Fluorescence)98/79 Salmonella typhi/paratyphi Nucleic Acid Detection Kit (Fluorescence)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Virology - RT & POC - other	W0105099099	Adenovirus/Rotavirus Ag Test Panel Ir03598/79 Human Papillomavirus (HPV) Antigen Test Kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
A2-antiplasmin	W0103020501	D-Dimer Test Kit Ir08798/79	– 98/79	Fiche EUDAMED Signaler une erreur
Bocavirus - NA reagents	W0105040518	Bocavirus Nucleic Acid Detection Kit (Fluorescence)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Chikungunya virus - NA reagents	W0105040525	Chikungunya Virus Nucleic Acid Detection Kit (Fluorescence)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Clost. diff. incl GDH and/or toxin a and b - RT & POC	W0105090106	Clostridium Difficile Related Test Kit Ir04298/79	– 98/79	Fiche EUDAMED Signaler une erreur
Coronavirus / influenza - RT & POC	W0105090601	Influ A+B/ADV/RSV Ag 4-in-1 Test Panel98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Haemophilus influenzae - NA reagents	W0105011610	Haemophilus influenzae Nucleic Acid Detection Kit (Fluorescence)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Influenza & para influenza - NA reagents	W0105040504	Influenza A/B Virus Nucleic Acid Detection Kit (Fluorescence)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Influenza a and /or b - RT & POC	W0105099004	Influenza A+B Ag Test Kit Ir04398/79	– 98/79	Fiche EUDAMED Signaler une erreur
Legionella detection by NA reagents	W0105010503	Legionella Nucleic Acid Detection Kit (Sputum/BALF)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Legionella reagents - other	W0105010599	Legionella Nucleic Acid Detection Kit (Fluorescence, Sputum/BALF)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Monkeypox virus / mpox - NA reagent	W0105040532	Monkeypox Virus Nucleic Acid Detection Kit (Fluorescence)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Mononucleosis (ebv) - RT & POC	W0105099003	Norovirus GI/GII Antigen Detection Kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Mycoplasma / ureaplasma reagents - other	W0105010899	Mycoplasma pneumoniae Nucleic Acid Detection Kit (Fluorescence)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Mycoplasma antigen detection	W0105010801	Mycoplasma pneumoniae Nucleic Acid Detection Kit Nc03698/79	– 98/79	Fiche EUDAMED Signaler une erreur
Neisseria meningitidis - NA reagents	W0105011611	Neisseria meningitidis Nucleic Acid Detection Kit (Fluorescence)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Parvovirus b 19 - NA reagents	W0105040509	Parainfluenza Virus (I-IV) Nucleic Acid Detection Kit (Fluorescence)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Plasmodium (malaria) - NA reagents	W0105050309	Plasmodium Nucleic Acid Detection Kit (Fluorescence)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Respiratory syncytial virus (rsv) - NA reagents	W0105040505	Respiratory Syncytial Virus (A/B) Nucleic Acid Detection Kit (Fluorescence)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Rhinovirus - NA reagents	W0105040520	Rhinovirus Nucleic Acid Detection Kit (Fluorescence)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Rsv - RT & POC	W0105099002	RSV Respiratory Syncytial Virus Ag Test Kit Ir04598/79	– 98/79	Fiche EUDAMED Signaler une erreur
Strep. a - RT & POC	W0105090103	Strep A Ag Test Kit Ir04498/79	– 98/79	Fiche EUDAMED Signaler une erreur
Streptococcal detection by NA reagents	W0105011102	Streptococcus pneumoniae Nucleic Acid Detection Kit (Fluorescence)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
West nile virus - NA reagent	W0105040526	West Nile Virus Nucleic Acid Detection Kit (Fluorescence)98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Zika virus - NA reagents	W0105040531	Zika Virus Nucleic Acid Detection Kit (Fluorescence)98/79	– 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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