Manufacturer

Cybereagen

ChinaLegal entities : Hangzhou Cybereagen Biotech Co., Ltd.

Markets : Germany

EU representative : CMC Medical Devices & Drugs SL (Spain)

38 categories, 56 models including 56 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
D-dimer	W0103020503	D-Dimer (DD) Assay Reagent Kit (CMIA) C2KD00198/79 D-Dimer (DD) Rapid Test Device (Whole blood/Plasma） E051001D98/79 D-Dimer (DD) Rapid Test Device (Plasma) E061101D98/79 D-Dimer Rapid Test Device (Plasma) E041101D98/79 D-Dimer Rapid Test Device (whole blood/plasma) E011001D98/79 1 other D-Dimer Rapid Test Device(Colloidal Gold) E030501D98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria)	W0105050209	Malaria Ag P.f (HRP-Ⅱ) Assay Reagent Kit (CMIA) C2KC00398/79 Malaria P.f. Rapid Test Device (whole blood) A270901D98/79 Malaria P.f.Pan Antigen Rapid Test Device (whole blood) A280901D98/79 Malaria P.fP.v Rapid Test Device (whole blood) A290901D98/79 Serum Amyloid A (SAA) Assay Reagent Kit (CMIA) C2KC00298/79	– 98/79	EUDAMED record Report an error
H. pylori antigen detection	W0105010401	H. pylori Antigen Rapid Test Strip(Feces) D090401S98/79 H.Pylori Antigen Rapid Test Device (feces) D060401D98/79 H.Pylori(HP) Antibody Rapid Test Device (whole blood/serum/plasma) D070501D98/79	– 98/79	EUDAMED record Report an error
Syphilis antigen detection	W0105010301	Syphilis Rapid Test (serum/plasma) A451401D98/79 Syphilis Rapid Test Device (serum/plasma/whole blood) A300501D98/79 Syphilis Rapid Test Strip (Whole Blood/Serum/Plasma) A460501S98/79	– 98/79	EUDAMED record Report an error
Adenovirus	W0105040601	Adenovirus Rapid Test Device(Feces) A320401D98/79 Adenovirus Rapid Test Device（Nasal swab） A501301D98/79	– 98/79	EUDAMED record Report an error
Dengue virus	W0105040611	Dengue IgGIgM Rapid Test Device (whole blood/serum/plasma) A250501D98/79 Dengue NS1 Rapid Test Device (whole blood/serum/plasma) A260501D98/79	– 98/79	EUDAMED record Report an error
H. pylori antibody assays	W0105010402	H. pylori (HP) Antibody Rapid Test Device(Serum/Plasma) D121401D98/79 H.Pylori Ab Rapid Test Device(Whole blood/Serum/Plasma) D080501D98/79	– 98/79	EUDAMED record Report an error
Mycoplasma antibody assays	W0105010802	M.Pneumonia IgG/IgM Rapid Test Device(whole blood/serum/plasma) A120501D98/79 Mycoplasma pneumoniae IgG antibody Assay Reagent Kit (CMIA) C2KC00498/79	– 98/79	EUDAMED record Report an error
Viral antigen/antibody detection - other	W0105040699	AdenovirusRotavirus Combo Rapid Test Device(Feces) A330401D98/79 RSV Rapid Test Device (Swab) A431301D98/79	– 98/79	EUDAMED record Report an error
Bacteriology immunoassay - other	W0105011799	Typhoid IgG/IgM Rapid Test Strip(whole blood/serum/plasma) A100501S98/79	– 98/79	EUDAMED record Report an error
Chikungunya virus	W0105040625	Chikungunya IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) A380501D98/79	– 98/79	EUDAMED record Report an error
Chlamydia pneumoniae antigen detection	W0105010112	M.Pneumonia Antigen Rapid Test Device (swab) D020501D98/79	– 98/79	EUDAMED record Report an error
Chlamydia trachomatis antibody igm	W0105010111	Infectious Mononucleosis Igm Rapid Test Device(Whole Blood/Serum/Plasma) A410501D98/79	– 98/79	EUDAMED record Report an error
Haemophilus influenzae	W0105011710	Influenza A&B Rapid Test (Nasopharyngeal swab) A170101T98/79	– 98/79	EUDAMED record Report an error
Hav antibody igm	W0105020104	HAV IgM Rapid Test Device(Serum/Plasma) A531401D98/79	– 98/79	EUDAMED record Report an error
Hav reagents - other	W0105020199	HAV IgGIgM Rapid Test Device(Serum/Plasma) A341401D98/79	– 98/79	EUDAMED record Report an error
HCV antigen	W0105020301	HCV Rapid Test Device (Serum/Plasma/Whole blood) A510501D98/79	– 98/79	EUDAMED record Report an error
Hev antigen	W0105020501	HEV IgM Rapid Test Device (Serum/Plasma) A401401D98/79	– 98/79	EUDAMED record Report an error
HPV antigen / antibodies	W0105041001	HPV IgM Rapid Test Device (serum) A111701D98/79	– 98/79	EUDAMED record Report an error
Hsv 1 igg	W0105040306	Herpes Simplex Virus -Ⅰ IgG (HSV-Ⅰ IgG) Assay Reagent Kit (CMIA) C2KE00198/79	– 98/79	EUDAMED record Report an error
Hsv 1 igm	W0105040307	Herpes Simplex Virus -Ⅰ IgM (HSV-Ⅰ IgM) Assay Reagent Kit (CMIA) C2KE00598/79	– 98/79	EUDAMED record Report an error
Hsv 1+2 igg	W0105040303	Herpes Simplex Virus -Ⅰ/Ⅱ IgG (HSV-Ⅰ/Ⅱ IgG) Assay Reagent Kit (CMIA) C2KE00398/79	– 98/79	EUDAMED record Report an error
Hsv 1+2 igm	W0105040304	Herpes Simplex Virus -I/II IgM (HSV-I/II IgM) Assay Reagent Kit (CMIA) C2KE00498/79	– 98/79	EUDAMED record Report an error
Hsv 2 igg	W0105040309	Herpes Simplex Virus -Ⅱ IgG (HSV-Ⅱ IgG) Assay Reagent Kit (CMIA) C2KE00298/79	– 98/79	EUDAMED record Report an error
Hsv 2 igm	W0105040310	Herpes Simplex Virus -II IgM (HSVII IgM) Assay Reagent Kit (CMIA) C2KE00698/79	– 98/79	EUDAMED record Report an error
Interleukin 6 (il-6)	W01030609	Interleukin-6 (IL-6) Assay Reagent Kit (CMIA) C2KC00198/79	– 98/79	EUDAMED record Report an error
Legionella antigen detection	W0105010501	The L.pn Rapid Test Device (urine) A160301D98/79	– 98/79	EUDAMED record Report an error
Leptospira	W0105011704	Leptospira IgG/IgM Rapid Test Device (Whole Blood/Serum/Plasma) A490501D98/79	– 98/79	EUDAMED record Report an error
Multiple parasites panels	W01050704	Filariasis IgG/IgM Rapid Test Device(Whole Blood/Serum/Plasma) A390501D98/79	– 98/79	EUDAMED record Report an error
Mycobacteria reagents - other	W0105010799	Tuberculosis Rapid Test (Whole Blood/Serum/Plasma) A480501T98/79	– 98/79	EUDAMED record Report an error
Neisseria meningitidis	W0105011711	Gonorrhea Rapid Test Device (Swab) C061301D98/79	– 98/79	EUDAMED record Report an error
Norovirus	W0105040616	Norovirus Rapid Test Device（Feces） A420401D98/79	– 98/79	EUDAMED record Report an error
Rotavirus	W0105040606	Rotavirus Rapid Test Device (feces) A440401D98/79	– 98/79	EUDAMED record Report an error
Salmonella antibody assays	W0105011002	Typhoid IgG/IgM Rapid Test (Serum/Plasma) A471401T98/79	– 98/79	EUDAMED record Report an error
Salmonella antigen detection	W0105011001	S.typhi Antigen Rapid Test Device (feces) A090401D98/79	– 98/79	EUDAMED record Report an error
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents	W0105070501	Vaginal pH Rapid Test Panel (Vaginal Swab) C130101C98/79	– 98/79	EUDAMED record Report an error
Strep. a detection by NA reagents	W0105011103	Strep A Rapid Test (Throat swab) A351301T98/79	– 98/79	EUDAMED record Report an error
Syphilis antibody assays total	W0105010302	The Anti-Treponema Pallidum(Anti-TP) Assay Reagent Kit (CMIA) C2KC00998/79	– 98/79	EUDAMED record Report an error

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