Manufacturer

Genesignbio

ChinaLegal entities : GeneSign Biotech (Xiamen)Co., Ltd.

Markets : Netherlands

EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)

25 categories, 87 models including 87 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Virology - RT & POC - other	W0105099099	1 test/kit5 refs98/79 25 tests/kit6 refs98/79 GeneSign Hantavirus IgG/IgM Rapid Test 1 test/kit98/79 GeneSign Hantavirus IgG/IgM Rapid Test 25 tests/kit98/79 GeneSign JEV IgG/IgM Rapid Test 1 test/kit98/79 23 others GeneSign JEV IgG/IgM Rapid Test 25 tests/kit98/79 GeneSign Measles IgG/IgM Rapid Test 1 test/kit98/79 GeneSign Measles IgG/IgM Rapid Test 25 tests/kit98/79 GeneSign Nipah Virus Antigen Rapid Test 1 test/kit98/79 GeneSign Nipah Virus Antigen Rapid Test 25 tests/kit98/79 GeneSign Nipah Virus IgG/IgM Rapid Test 1 test/kit98/79 GeneSign Nipah Virus IgG/IgM Rapid Test 25 tests/kit98/79 GeneSign Rapid Norovirus I+II/Rota/Adeno/Astv Ag Test 1 test/kit98/79 GeneSign Rapid Norovirus I+II/Rota/Adeno/Astv Ag Test 25 tests/kit98/79 GeneSign Respiratory Combo Antigen Rapid Test (Swab Specimen) (COVID-19/Flu A/ Flu B/RSV/ADV/MP/hMPV/HPIV/RhV/Strep A/S. Pneumoniae/L. Pneumophila) 1 test/kit98/79 GeneSign Respiratory Combo Antigen Rapid Test (Swab Specimen) (COVID-19/Flu A/ Flu B/RSV/ADV/MP/hMPV/HPIV/RhV/Strep A/S. Pneumoniae/L. Pneumophila) 20 tests/kit98/79 GeneSign Respiratory Combo Antigen Rapid Test (Swab Specimen) (COVID-19/Flu A/ Flu B/RSV/ADV/MP/hMPV/Strep A/RhV) 1 test/kit98/79 GeneSign Respiratory Combo Antigen Rapid Test (Swab Specimen) (COVID-19/Flu A/ Flu B/RSV/ADV/MP/hMPV/Strep A/RhV) 25 tests/kit98/79 GeneSign SFTSV Antigen Rapid Test 1 test/kit98/79 GeneSign SFTSV Antigen Rapid Test 25 tests/kit98/79 GeneSign West Nile Virus Antigen Rapid Test 1 test/kit98/79 GeneSign West Nile Virus Antigen Rapid Test 25 tests/kit98/79 GeneSign Yellow Fever NS1 Antigen Rapid Test 1 test/kit98/79 GeneSign Yellow Fever NS1 Antigen Rapid Test 25 tests/kit98/79 GeneSign Zika NS1 Antigen Rapid Test 1 test/kit98/79 GeneSign Zika NS1 Antigen Rapid Test 25 tests/kit98/79 GeneSign Zika Virus IgG/IgM Rapid Test 1 test/kit98/79 GeneSign Zika Virus IgG/IgM Rapid Test 25 tests/kit98/79	– 98/79	EUDAMED record Report an error
Other multiple pathogens - RT & POC	W0105090699	1 test/kit7 refs98/79 25 tests/kit7 refs98/79 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 others 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	EUDAMED record Report an error
Bacteriology - RT & POC - other	W0105090199	1 test/kit3 refs98/79 25 tests/kit3 refs98/79 GeneSign Brucella IgG/IgM Rapid Test 1 test/kit98/79 GeneSign Brucella IgG/IgM Rapid Test 25 tests/kit98/79 GeneSign TB IgG/IgM Rapid Test 1 test/kit98/79 1 other GeneSign TB IgG/IgM Rapid Test 25 tests/kit98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	1 test/kit3 refs98/79 25 tests/kit3 refs98/79 GeneSign Malaria P.f/P.v Ab Rapid Test 1 test/kit98/79 GeneSign Malaria P.f/P.v Ab Rapid Test 25 tests/kit98/79	– 98/79	EUDAMED record Report an error
Coronavirus / influenza - RT & POC	W0105090601	1 test/kit98/79 25 tests/kit98/79	– 98/79	EUDAMED record Report an error
Coronavirus antibody (ab) - RT & POC	W0105090502	1 test/kit98/79 25 tests/kit98/79	– 98/79	EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC	W0105090501	1 test/kit2 refs98/79 25 tests/kit2 refs98/79	– 98/79	EUDAMED record Report an error
D-dimer - RT & POC	W0103020803	1 test/kit98/79 25 tests/kit98/79	– 98/79	EUDAMED record Report an error
Dengue - RT & POC	W0105099007	1 test/kit3 refs98/79 25 tests/kit3 refs98/79	– 98/79	EUDAMED record Report an error
Gonococcal antigen detection	W0105010201	1 test/kit98/79 25 tests/kit98/79	– 98/79	EUDAMED record Report an error
H. pylori antibody assays	W0105010402	1 test/kit98/79 25 tests/kit98/79	– 98/79	EUDAMED record Report an error
H. pylori antigen detection	W0105010401	1 test/kit98/79 25 tests/kit98/79	– 98/79	EUDAMED record Report an error
Hav antibody (total)	W0105020102	1 test/kit98/79 25 tests/kit98/79	– 98/79	EUDAMED record Report an error
HPV antigen / antibodies	W0105041001	1 test/kit3 refs98/79 25 tests/kit3 refs98/79	– 98/79	EUDAMED record Report an error
Hsv 1 igg	W0105040306	GeneSign HSV-I IgM/IgG Rapid Test 1 test/kit98/79 GeneSign HSV-I IgM/IgG Rapid Test 25 tests/kit98/79	– 98/79	EUDAMED record Report an error
Hsv 2 antibodies - total	W0105040308	1 test/kit98/79 25 tests/kit98/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	1 test/kit98/79 25 tests/kit98/79	– 98/79	EUDAMED record Report an error
Monkeypox virus / mpox RT & POC	W0105099008	1 test/kit98/79 25 tests/kit98/79	– 98/79	EUDAMED record Report an error
Mycoplasma antigen detection	W0105010801	1 test/kit98/79 25 tests/kit98/79	– 98/79	EUDAMED record Report an error
Rsv - RT & POC	W0105099002	1 test/kit98/79 25 tests/kit98/79	– 98/79	EUDAMED record Report an error
Salmonella antibody assays	W0105011002	1 test/kit98/79 25 tests/kit98/79	– 98/79	EUDAMED record Report an error
Salmonella antigen detection	W0105011001	1 test/kit98/79 25 tests/kit98/79	– 98/79	EUDAMED record Report an error
Strep. a - RT & POC	W0105090103	1 test/kit98/79 25 tests/kit98/79	– 98/79	EUDAMED record Report an error
Syphilis antibody assays total	W0105010302	1 test/kit98/79 25 tests/kit98/79	– 98/79	EUDAMED record Report an error
Rotavirus	W0105040606	1 test/kit98/79	– 98/79	EUDAMED record Report an error

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