Manufacturer

Actest

ChinaLegal entities : ACtest Biotech Co., Ltd.

First countries of placing on the market declared in EUDAMED : Germany, Greece, Spain

EU representative : VidaQuick Biotech S.L. (Spain)

info@actest.com.cn

21 categories, 152 models including 152 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
Bacteriology - RT & POC - other	W0105090199	Brucella Abortus Antigen Rapid Test Cassette98/79 Campylobacter Rapid Test CAM-7-F98/79 Campylobacter Rapid Test Cassette CAM-2-F98/79 Candida albicans and Trichomonas Vaginalis Combo Rapid Test CT-5-E98/79 Candida albicans Rapid Test Cassette CA-2-E98/79 43 others Candida albicans Rapid Test Cassette CA-2-Ez98/79 Candida albicans Rapid Test Cassette CAA-2-E98/79 Cryptococcus Antigen Rapid Test Cassette CRY-2-D98/79 Gonorrhea Rapid Test Cassette98/79 H. pylori Antibody Rapid Test Cassette HP-2-C98/79 H. pylori Antibody Rapid Test Cassette HP-2-D98/79 H. pylori Antibody Rapid Test Dipstick98/79 H. pylori Antigen Rapid Test Cassette HP-2-F98/79 H. pylori Antigen Rapid Test Dipstick98/79 H. pylori Antigen Rapid Test HP-4-O98/79 H.pylori Antigen Rapid Test HP-7-F98/79 H.pylori/Transferrin Combo Rapid Test HPTF-5-F98/79 Leptospira IgG/IgM Combo Rapid Test LGM-5-D98/79 Leptospira IgG/IgM Rapid Test Cassette LGM-2-D98/79 Lyme IgG/IgM Rapid Test Cassette LYGM-2-D98/79 Mycobacterium tuberculosis Antigen Rapid Test98/79 Mycoplasma Pneumoniae IgG/IgM Combo Rapid Test Cassette MPGM-5-D98/79 Salmonella paratyphi Antigen Rapid Test98/79 Salmonella paratyphi Antigen Rapid Test Cassette98/79 Salmonella typhi and paratyphi Antigen Combo Rapid Test98/79 Salmonella typhi and paratyphi Antigen Combo Rapid Test Cassette98/79 Salmonella typhi and paratyphi B Antigen Combo Rapid Test98/79 Salmonella typhi Antigen Rapid Test98/79 Salmonella typhi Antigen Rapid Test Cassette98/79 Scrub Typhus IgG/IgM Rapid Test Cassette98/79 Shigella Flexneri Antigen Rapid Test98/79 Shigella Rapid Test Cassette SHI-5-F98/79 Shigella Rapid Test SHI-7-F98/79 Shigella Sonnei Antigen Rapid Test98/79 Streptococcus pneumoniae and Legionella pneumophila Combo Rapid Test Cassette98/79 Tetanus Rapid Test Cassette TET-2-D98/79 Trichomonas Vaginalis Rapid Test Cassette TRV-2-E98/79 Trichomonas Vaginalis Rapid Test Cassette TRV-2-Ez98/79 Tuberculosis (TB) Rapid Test Cassette98/79 Tuberculosis (TB) Rapid Test Dipstick98/79 Typhoid Rapid Test3 refs98/79 Vibrio choierae O1/O139 Combo Rapid Test Cassette98/79 Vibrio cholerae O1 (VC O1) Rapid Test Cassette98/79 Vibrio Cholerae O1 Inaba (VC O1 Inaba) Rapid Test Cassette98/79 Vibrio Cholerae O1 Ogawa (VC O1 Ogawa) Rapid Test Cassette98/79 Vibrio Cholerae O1/O139 Combo Rapid Test98/79 Vibrio cholerae O139 (VC O139) Rapid Test Cassette98/79 Vibrio Cholerae O139, O1 Ogawa & Inaba Combo Rapid Test Cassette2 refs98/79	– 98/79	EUDAMED record Report an error
Virology - RT & POC - other	W0105099099	Adenovirus Antigen Rapid Test Cassette ADE-2-L98/79 Adenovirus Rapid Test ADE-7-F98/79 Adenovirus Rapid Test Cassette ADE-2-F98/79 Astrovirus Rapid Test AST-7-F98/79 Astrovirus Rapid Test Cassette AST-2-F98/79 27 others Chikungunya IgG/IgM Rapid Test Cassette CHI-2-C98/79 Chikungunya IgG/IgM Rapid Test Cassette CHI-2-D98/79 Dengue IgG/IgM And NS1 Combo Rapid Test Cassette98/79 Dengue IgG/IgM Rapid Test Cassette DEN-2-D98/79 Dengue IgG/IgM Rapid Test Cassette DEN-2-Dz98/79 Dengue NS1 Rapid Test Cassette2 refs98/79 Ebola IgG/IgM Rapid Test Cassette EBO-2-D98/79 Enterovirus Antigen Rapid Test Cassette ENT-2-F98/79 EV71 IgM Rapid Test Cassette98/79 Hantavirus IgG/IgM Rapid Test Cassette HVGM-2-D98/79 HAV IgG/IgM Combo Rapid Test Cassette HAGM-5-D98/79 HAV IgM Rapid Test Cassette HAM-2-D98/79 HEV IgG/IgM Rapid Test Cassette HEGM-2-C98/79 HPIV Rapid Test Cassette98/79 HPV Antigen Rapid Test HPV-2-E98/79 Influenza type A (H5N1) Antigen Rapid Test Cassette98/79 Measles IgG/IgM Rapid Test MEA-2-D98/79 Norovirus Rapid Test Cassette NOR-2-F98/79 Norovirus Rapid Test NOR-7-F98/79 Rhinovirus Rapid Test Cassette RHV-2-E98/79 Rotavirus Rapid Test Cassette ROT-2-F98/79 Rotavirus Rapid Test ROT-7-F98/79 Varicella Zoster Virus IgM Rapid Test Cassette VZM-2-D98/79 West Nile Virus IgG/IgM Rapid Test Cassette WNGM-2-D98/79 Zika IgG/IgM and NS1 Combo Rapid Test Cassette98/79 Zika IgG/IgM Rapid Test Cassette ZIKM-2-D98/79 Zika NS1 Rapid Test Cassette98/79	– 98/79	EUDAMED record Report an error
Other multiple pathogens - RT & POC	W0105090699	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 others 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 refs98/79 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	EUDAMED record Report an error
Parasites - RT & POC - other	W0105090499	Chagas Rapid Test Cassette CHA-2-C98/79 Chagas Rapid Test Cassette CHA-2-D98/79 Cryptosporidium and Giardia Lamblia Combo Rapid Test Cassette CGL-5-F98/79 Cryptosporidium Rapid Test Cassette CRY-2-F98/79 Entamoeba histolytica Rapid Test Cassette ENH-2-F98/79 5 others Entamoeba/Giardia/Crypto Combo Rapid Test Cassette (1 Window)98/79 Entamoeba/Giardia/Crypto Combo Rapid Test Cassette (3 Windows)98/79 Filariasis IgG/IgM Rapid Test2 refs98/79 Giardia Lamblia Rapid Test Cassette GIL-2-F98/79 Leishmania IgG/IgM Rapid Test Cassette LEI-2-D98/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	H1N1 Antigen Rapid Test Cassette98/79 Influenza A Rapid Test Cassette IFA-2-K98/79 Influenza A Rapid Test Dipstick98/79 Influenza A+B Rapid Test Cassette IFAB-2-K98/79 Influenza A+B Rapid Test Cassette IFLU-2-K98/79 2 others Influenza A+B Rapid Test Dipstick98/79 Influenza A/B+H1N1 Combo Rapid Test Cassette98/79	– 98/79	EUDAMED record Report an error
Controls infectious immunology - RT & POC	W0105094001	COVID-19 and Influenza A+B Antigen Combo Control98/79 Influenza A+B Control Q-FLAB-E98/79 RSV Control Q-RSV-E98/79 SARS-CoV-2 Antigen Control98/79 SARS-CoV-2/Influenza A+B/RSV Antigen Combo Control98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	Malaria P.f. /Pan Rapid Test Cassetle98/79 Malaria P.f. Rapid Test Cassette MAF-2-D98/79 Malaria P.f. Rapid Test Dipstick98/79 Malaria P.f./P.v. /Pan Rapid Test Cassette MAFVN-2-D98/79 Malaria P.f./P.v. Rapid Test Cassette MAFV-2-D98/79	– 98/79	EUDAMED record Report an error
Clost. diff. incl GDH and/or toxin a and b - RT & POC	W0105090106	Clostridium difficile GDH Rapid Test Cassette CLO-2-F98/79 Clostridium difficile GDH+Toxin A+Toxin B Combo Rapid Test CGAB-7-F98/79 Clostridium difficile Toxin A +Toxin B Combo Rapid Test Cassette CTAB-5-F98/79 Clostridium diffilcile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette98/79	– 98/79	EUDAMED record Report an error
Coronavirus / influenza - RT & POC	W0105090601	COVID-19 and Influenza A+B Antigen Combo Rapid Test2 refs98/79 SARS-CoV-2 and Influenza A+B Antigen Combo Rapid Test98/79 SARS-CoV-2/Influenza A+B/RSV Antigen Combo Rapid Test98/79	– 98/79	EUDAMED record Report an error
Mononucleosis (ebv) - RT & POC	W0105099003	EBV VCA and EBNA IgG Combo Rapid Test Cassette EBCN-5-D98/79 EBV VCA IgG Rapid Test Cassette EBVG-2-D98/79 MONO Rapid Test Cassette MONO-2-D98/79	– 98/79	EUDAMED record Report an error
Syphilis - RT & POC	W0105090105	Syphilis Rapid Test Cassette SYP-2-C98/79 Syphilis Rapid Test Cassette SYP-2-D98/79 Syphilis Rapid Test Dipstick2 refs98/79	– 98/79	EUDAMED record Report an error
Coronavirus antibody (ab) - RT & POC	W0105090502	SARS-CoV-2 Antibody rapid test98/79 SARS-CoV-2 neutralizing Antibody rapid test98/79	– 98/79	EUDAMED record Report an error
Monkeypox virus / mpox RT & POC	W0105099008	Monkeypox Virus Antibody Rapid Test MXB-2-D98/79 Monkeypox Virus Antigen Rapid Test Cassette MXG-2-D98/79	– 98/79	EUDAMED record Report an error
Strep. a - RT & POC	W0105090103	Strep A Rapid Test Cassette (Control Line in Red) STA-2-G98/79 Strep A Rapid Test Dipstick (Control Line in Red)98/79	– 98/79	EUDAMED record Report an error
Strep. b - RT & POC	W0105090104	Strep B Rapid Test Cassette STB-2-E98/79 Strep B Rapid Test Dipstick98/79	– 98/79	EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC	W0105090501	SARS-CoV-2 Antigen rapid test4 refs98/79	– 98/79	EUDAMED record Report an error
Haemoglobin subtypes hba2, hbc, hbf, hbs, etc.(excl. hba1)	W0103010202	Sickle Cell Rapid Test SCD-2-D98/79	– 98/79	EUDAMED record Report an error
HPV antigen / antibodies	W0105041001	HPV Test HPV-1-A98/79	– 98/79	EUDAMED record Report an error
Immunochemistry readers	W0201020201	Rapid Test Reader aca-A012 refs	A IVDR	EUDAMED record Report an error
Legionella - RT & POC	W0105090108	Legionella pneumophila Rapid Test Cassette98/79	– 98/79	EUDAMED record Report an error
Rsv - RT & POC	W0105099002	RSV Rapid Test Cassette RSV-2-K98/79	– 98/79	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

Didn't find it?

Tell us what you are looking for. Requests show us which categories to add first.