Manufacturer

Hightopbio

ChinaLegal entities : Qingdao Hightop Biotech Co., Ltd.

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

EU representative : MedNet EC-REP GmbH (Germany)

45 categories, 76 models including 76 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	Antibodies to Tuberculosis(TB) IgG ELISA Test Kit (Serum/Plasma)98/79 Human Metapneumovirus Antigen Rapid Test H1911-21S98/79 Human Parainfluenza Virus Antigen Rapid Test98/79 Human Rhinovirus Antigen Rapid Test H1912-21S98/79 Measles Virus IgG/IgM Antibody Rapid Test H1437-21W98/79 7 others Multiple Respiratory Antigen Rapid Test H1915-41S98/79 Nov GI+GII/RovA/ADV Antigen Rapid Test98/79 Respiratory 7-in-1 IgM Antibody Rapid Test98/79 RV Rubella Antibodies IgM/IgG Rapid Test Kit(Colloidal Gold)98/79 SARS-CoV-2/ Flu A+B/ RSV/ ADV/ MP Antigen Rapid Test98/79 SARS-CoV-2/Flu A+B/AdV/RSV Antigen Rapid Test98/79 SARS-CoV-2/Flu A+B/RSV Antigen Rapid Test98/79	– 98/79	EUDAMED record Report an error
Bacteriology - RT & POC - other	W0105090199	Brucella Antigen Rapid Test H1429-21W98/79 Human Brucella IgM/IgG Antibody Rapid Test H1428-21W98/79 Tsutsugamushi IgM Antibody Rapid Test98/79 Vibrio Cholerae O1/O139 Antigen Rapid Test98/79	– 98/79	EUDAMED record Report an error
Parasites - RT & POC - other	W0105090499	Chagas Antibody Rapid Test H1436-21W98/79 TOXO Toxoplasma Antibody IgG Rapid Test Kit (Colloidal Gold)98/79 TOXO Toxoplasma Antibody IgM Rapid Test Kit (Colloidal Gold)98/79 TOXO Toxoplasma Antibody IgM/ IgG Rapid Test Kit (Colloidal Gold)98/79	– 98/79	EUDAMED record Report an error
Adenovirus	W0105040601	Adenovirus (Adv) IgG Antibody ELISA Test Kit98/79 Adenovirus (Adv) IgM Antibody ELISA Test Kit98/79 Card type98/79	– 98/79	EUDAMED record Report an error
Dengue virus	W0105040611	Card type, Card box type2 refs98/79 Dengue IgG ELISA Test Kit98/79 Dengue IgM ELISA Test Kit98/79	– 98/79	EUDAMED record Report an error
Respiratory syncytial virus (rsv)	W0105040605	Card type98/79 Respiratory Syncytial Virus (RSV) IgG Antibody ELISA Test Kit98/79 Respiratory Syncytial Virus (RSV) IgM Antibody ELISA Test Kit98/79	– 98/79	EUDAMED record Report an error
Brucella	W0105011701	Brucella IgG Antibody ELISA Test Kit98/79 Brucella IgM Antibody ELISA Test Kit98/79	– 98/79	EUDAMED record Report an error
Cmv - RT & POC	W0105099001	CMV Cytomegalovirus Antibody IgG Rapid Test (Colloidal Gold)98/79 CMV Cytomegalovirus Antibody IgM/IgG Rapid Test Kit (Colloidal Gold)98/79	– 98/79	EUDAMED record Report an error
D-dimer	W0103020503	Card type98/79 D-dimer Reagent Kit (Microparticles Chemiluminescent Immunoassay)98/79	– 98/79	EUDAMED record Report an error
H. pylori antigen detection	W0105010401	Card type98/79 Helicobacter pylori (H.P) Antigen ELISA Test Kit (Feces)98/79	– 98/79	EUDAMED record Report an error
Hav antibody igm	W0105020104	96T/Box 480T/Box98/79 Antibodies to Hepatitis A Virus (HAV) IgM ELISA Test Kit (Serum/Plasma)98/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Influenza A Antigen Rapid Test H1919-21S98/79 Influenza B Antigen Rapid Test H1918-21S98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	Malaria P.f (HRP2, pLDH) Rapid Test98/79 Malaria P.f/P.v/Pan Rapid Test H1433-41W98/79	– 98/79	EUDAMED record Report an error
Syphilis antibody assays total	W0105010302	Antibodies to Treponema Pallidum (TP) ELISA Test Kit (Serum/Plasma)98/79 Syphilis TP Reagent Kit（Microparticles Chemiluminescent Immunoassay）98/79	– 98/79	EUDAMED record Report an error
Automated urine analysers - consumables	W020101020185	UF-CELLSHEATH98/79	– 98/79	EUDAMED record Report an error
Chlamydia ag - RT & POC	W0105090101	Ct Chlamydia Trachomatis Antigen Rapid Test Kit (Colloidal Gold)98/79	– 98/79	EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC	W0105090501	SARS-CoV-2 Antigen Rapid Test98/79	– 98/79	EUDAMED record Report an error
Ebv antibodies - other	W010504040199	Epstein-Barr Virus IgA Antibody ELISA Test Kit98/79	– 98/79	EUDAMED record Report an error
Ebv igg - total	W010504040102	Epstein-Barr Virus IgG Antibody ELISA Test Kit98/79	– 98/79	EUDAMED record Report an error
Ebv igm - total	W010504040103	Epstein-Barr Virus IgM Antibody ELISA Test Kit98/79	– 98/79	EUDAMED record Report an error
H. pylori antibody assays	W0105010402	Card type98/79	– 98/79	EUDAMED record Report an error
Haemoglobin determinations (total hb)	W0103010201	Card type98/79	– 98/79	EUDAMED record Report an error
Hantavirus / bunyavirus - NA reagents	W0105040514	Epidemic Hemorrhagic Fever (EHF) IgM Antibody Enzyme Immunoassay Test Kit98/79	– 98/79	EUDAMED record Report an error
Hev antibody igm	W0105020505	Antibodies to Hepatitis E Virus (HEV) IgM ELISA Test Kit (Serum/Plasma)98/79	– 98/79	EUDAMED record Report an error
Hsv 1 igg	W0105040306	Antibodies to Herpes Simplex Virus I IgG Test Kit (ELISA)98/79	– 98/79	EUDAMED record Report an error
Hsv 1 igm	W0105040307	Antibodies to Herpes Simplex Virus I IgM Test Kit (ELISA)98/79	– 98/79	EUDAMED record Report an error
Hsv 2 igg	W0105040309	Antibodies to Herpes Simplex Virus II IgG Test Kit (ELISA)98/79	– 98/79	EUDAMED record Report an error
Hsv 2 igm	W0105040310	Antibodies to Herpes Simplex Virus II IgM Test Kit (ELISA)98/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza	W0105040604	Card type98/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza - NA reagents	W0105040504	Diagnostic Kit for Influenza A virus RNA (Fluorescence RT-PCR)98/79	– 98/79	EUDAMED record Report an error
Measles virus igg	W0105040702	Measles Virus(MV) IgG Antibody ELISA Test Kit98/79	– 98/79	EUDAMED record Report an error
Measles virus igm	W0105040703	Measles Virus (MV) IgM Antibody ELISA Test Kit98/79	– 98/79	EUDAMED record Report an error
Monkeypox virus / mpox RT & POC	W0105099008	Mpox Virus Antigen Rapid Test H200S98/79	– 98/79	EUDAMED record Report an error
Mycobacterial antibody assays	W0105010702	Antibodies to Mycobacterium Tuberculosis(TB) IgM ELISA Test Kit98/79	– 98/79	EUDAMED record Report an error
Mycoplasma antibody assays	W0105010802	Card type, Card box type2 refs98/79	– 98/79	EUDAMED record Report an error
Mycoplasma antigen detection	W0105010801	Card type98/79	– 98/79	EUDAMED record Report an error
Other multiple pathogens - RT & POC	W0105090699	Flu A+B/MP Antigen Rapid Test98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria)	W0105050209	Card type, Card box type2 refs98/79	– 98/79	EUDAMED record Report an error
Rubella virus igg	W0105040102	RV Rubella Antibodies IgG Rapid Test Kit (Colloidal Gold)98/79	– 98/79	EUDAMED record Report an error
Rubella virus igm	W0105040103	RV Rubella Antibodies IgM Rapid Test Kit(Colloidal Gold)98/79	– 98/79	EUDAMED record Report an error
Strep. a - RT & POC	W0105090103	Strep A Antigen Rapid Test (Immunochromatography)98/79	– 98/79	EUDAMED record Report an error
Strep. pneumoniae - RT & POC	W0105090109	Streptococcus Pneumoniae Antigen Rapid Test98/79	– 98/79	EUDAMED record Report an error
Streptococcal direct antigen detection	W0105011101	Card type98/79	– 98/79	EUDAMED record Report an error
Tb-igra (interferon-gamma-release assay)	W0105010704	TB Igra ELISA Test Kit98/79	– 98/79	EUDAMED record Report an error
Virology reagents - other	W01050499	Card type, Card box type98/79	– 98/79	EUDAMED record Report an error

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