Manufacturer

Dezhou Guoke Medical Technology

ChinaLegal entities : Dezhou Guoke Medical Technology Co., Ltd.

Markets : Germany · Spain

Approvals : EU – class A

EU representative : MedPath GmbH (Germany)

office@guoke-medical.com

37 categories, 98 models including 98 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
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Category	EMDN code	Registered models	Class	Contact
Other multiple pathogens - RT & POC	W0105090699	Candida albicans / Trichomonas vaginalis / Gardnerella vaginalis Triplex Rapid Test Kit98/79 COVID-19&Flu A/B&RSV&Adenovirus Antigen Combo Rapid Test Cassette(Colloidal Gold ) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 COVID-19&Flu A/B&RSV&Adenovirus&MP&HMPV Antigen Combo Rapid Test Cassette(Colloidal Gold ) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 COVID-19&Flu A/B&RSV&Adenovirus&MPAntigen Combo Rapid TestCassette(Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 Dengue Virus IgG/IgM/NS1 & Chikungunya Virus IgM/IgG Combo Rapid Test Kit98/79 12 others Enterovirus 71 (EV71) and Coxsackievirus A16 (CA16) Antigen Combo Rapid Test Kit98/79 Enterovirus 71 (EV71) IgM/IgG Antibody and Coxsackievirus A16 (CA16) IgM/IgG Antibody Combo Rapid Test Kit98/79 Group A Rotavirus & Adenovirus & Norovirus Ag Detection Kit (Immunofluorescence Chromatography)98/79 Group A Rotavirus / Adenovirus / Norovirus Antigen Triplex Rapid Test Kit98/79 Influenza A/B & RSV & Adenovirus & hMPV & PIV & M. pneumoniae Ag Combo Rapid Test Kit98/79 Influenza A/B, SARS-CoV-2, RSV, Adenovirus, Measles Virus, Mumps Virus and HPIV Antigen Combo Rapid Test Kit98/79 Rotavirus / Adenovirus / Norovirus (GI/GII) Ag Combo Rapid Test Kit98/79 RSV & ADV Ag Detection Kit (Immunofluorescence Chromatography)98/79 SARS-CoV-2 / Flu A / Flu B/ ADV Ag Combo Rapid Test Kit98/79 SARS-CoV-2, Influenza A/B, RSV, Adenovirus, M. pneumoniae, hMPV, Rhinovirus, hPIV (1/2/3) and B. pertussis Antigen Combo Rapid Test Kit98/79 Toxoplasma gondii IgG/IgM, CMV IgG/IgM and Rubella Virus IgG Antibody Combo Rapid Test Kit98/79 Zika Virus IgG/IgM Antibody and Yellow Fever Virus IgG/IgM Antibody Combo Rapid Test Kit98/79	– 98/79	EUDAMED record Report an error
Virology - RT & POC - other	W0105099099	Adenovirus Antigen Rapid Test Cassette (Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 Adenovirus IgM Ab Rapid Test Kit GKPD10098/79 COVID-19 Antigen Rapid Test Cassette (Colloidal Gold ) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 Flu A & Flu B&Respiratory Syncytial Virus&Adenovirus Antigen Rapid Test Cassette(Colloidal Gold) 1T/BOX,10T/BOX,20T/BOX,25T/BOX,40T/BOX,50T/BOX98/79 HAV IgM Rapid Test Cassette(Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 12 others Influenza type A and B(Flu A/B) Ag Rapid Test Cassette(Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 Mumps Virus IgM Ab Rapid Test Kit GKPD10198/79 Neisseria Gonorrheae(NGH) AntigenRapid TestStrip(ColloidalGold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 Nipah Virus Ag Rapid Test Kit98/79 Nipah Virus IgG/IgM Ab Rapid Test Kit98/79 Noroviruses Rapid Test Cassette(Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 Rotavirus & Adenovirus Antigen Rapid Test Cassette (Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 Rotavirus Antigen Rapid Test Cassette(Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 SARS-CoV-2&Respiratory Syncytial Virus&Flu A & Flu B Antigen Rapid Test Cassette(Colloidal Gold) 1T/BOX,10T/BOX,20T/BOX,25T/BOX,40T/BOX,50T/BOX98/79 Strep A Antigen Rapid Test Cassette (Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 Syphilis (Tp) Ab Rapid Test Cassette (Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 Yellow Fever Virus IgG/IgM Antibody Rapid Test Kit98/79	– 98/79	EUDAMED record Report an error
Reagents for (automated) haematology analyzer - other	W0103010199	Cleaner used for Hematology Analysis 50ml、200ml Diluent used for Hematology Analysis 5L、20L（SXHA610/650/660/680 Diluent） Diluent used for Hematology Analysis(HAS330) 5L、20L（LHAS310/330/360/380 Diluent） FOB Rapid Test Cassette (Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 FOB/TF Rapid Test Cassette(Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 3 others Lyse used for Hematology Analysis （Lyse） 500mL（HAS310/330/360/380 Lyse） Lyse used for Hematology Analysis(LH) 100ml 、250ml（SXHA610/650/660/680 LH Lyse） Lyse used for Hematology Analysis（DIFF） 500mL（SXHA610/650/660/680 DIFF Lyse）	A IVDR, 98/79	EUDAMED record Report an error
IVD instruments - other	W0299	Automatic fluorescence microscopic image scanning analyzer GK-IMG1000 / GK-IMG3000 / GK-IMG5000 Biochemical and immunoassay analyzer Semi-auto Chemistry Analyzer：CAS60,CAS70,CAS80,CAS90； Auto Chemistry Analyzer:Mini 60、CAS100、S120pro、CAS200、CAS300、CAS400 Electrolyte Analyzer IMS-972Plus-3、IMS-972Plus-5、IMS-972Plus-F Fluorescence Biological Microscope GK-23M、GK-33M、GK-500DM、GK-750DM Fully Auto POCT Chemiluminescence Immunoassay Analyzer CLS60 1 other Fully-Automatic fluorescence microscopic Images scanning and analysis system GK-IMG8000、GK-IMG8100、GK-IMG8200	A IVDR	EUDAMED record Report an error
Chikungunya virus	W0105040625	Chikungunya Virus Ag Rapid Test Kit GKPD11798/79 Chikungunya Virus IgG/IgM Ab Rapid Test Kit GKPD11898/79 Chikungunya Virus IgG/IgM Antibody and Antigen Combo Rapid Test Kit GKPD11998/79	– 98/79	EUDAMED record Report an error
Dengue virus	W0105040611	Dengue IgG/IgM Detection Kit (Immunofluorescence Chromatography)98/79 Dengue IgG/lgM Antibody Rapid Test Cassette (Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 Dengue NS1 Antigen Rapid Test Cassette (Colloidal Gold) 1T/BOX,10T/BOX,20T/BOX,25T/BOX,40T/BOX,50T/BOX98/79	– 98/79	EUDAMED record Report an error
Mycoplasma antigen detection	W0105010801	DOA Rapid Urine Test Device Strip/Cassette/Panel(Colloidal Gold ) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 Mycoplasma pneumoniae Ab Detection Kit (Immunofluorescence Chromatography)98/79 TB IgG/lgM Rapid Test Cassette (Colloidal Gold) 1T/BOX,10T/BOX,20T/BOX,25T/BOX,40T/BOX,50T/BOX98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	Malaria P.f/P.v Ag Rapid Test Kit GKPD11498/79 Plasmodium falciparum and Pan-plasmodium Antigen Detection Kit (Immunofluorescence Chromatography)98/79 Plasmodium falciparum and Plasmodium vivax Antigen Detection Kit (Immunofluorescence Chromatography)98/79	– 98/79	EUDAMED record Report an error
Rsv - RT & POC	W0105099002	Respiratory Syncytial Virus (RSV) IgM Ab Rapid Test Kit GKPD10298/79 RSV Ag Detection Kit (Immunofluorescence Chromatography)98/79 RSV Antigen Rapid Test Cassette (ColloidalGold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79	– 98/79	EUDAMED record Report an error
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr)	W0202010101	Fully Auto 3-Part Hematology Analyzer HAS33098/79 Fully Auto 5-Part Hematology Analyzer SXHA610、SXHA660、SXHA68098/79	– 98/79	EUDAMED record Report an error
Bacteriology immunoassay - other	W0105011799	Typhoid IgG/lgM Antibody Rapid Test Cassette (Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 Vibrio cholerae O1 and O139 Antigen Rapid Test Kit98/79	– 98/79	EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC	W0105090501	MERS-CoV Antigen Rapid Test Kit98/79 SARS-CoV-2 Ag Detection Kit (Immunofluorescence Chromatography)98/79	– 98/79	EUDAMED record Report an error
Dengue - RT & POC	W0105099007	Dengue IgG/IgM/NS1 Rapid Test Kit98/79 Dengue NS1 Detection Kit (Immunofluorescence Chromatography)98/79	– 98/79	EUDAMED record Report an error
H. pylori antigen detection	W0105010401	FOB/TRF/HP Rapid Test Cassette(Colloidal Gold 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79 H.Pylori Antibody Rapid Test Cassette(Colloidal Gold) 1T/box,10T/box,20T/box,25T/box,40T/box,50T/box98/79	– 98/79	EUDAMED record Report an error
Monkeypox virus / mpox RT & POC	W0105099008	Mpox Virus Ag Rapid Test Kit GKPD12398/79 Mpox Virus IgG/IgM Ab Rapid Test Kit GKPD12498/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria)	W0105050209	Malaria Pf Antigen Rapid Test Cassette(Colloidal Gold) 1T/BOX,10T/BOX,20T/BOX,25T/BOX,40T/BOX,50T/BOX98/79 Malaria Pf/Pan Antigen Rapid Test Cassette(Colloidal Gold) 1T/BOX,10T/BOX,20T/BOX,25T/BOX,40T/BOX,50T/BOX98/79	– 98/79	EUDAMED record Report an error
Adenovirus	W0105040601	ADV Ag Detection Kit (Immunofluorescence Chromatography)98/79	– 98/79	EUDAMED record Report an error
Bacteriology - RT & POC - other	W0105090199	Gardnerella vaginalis Ag Rapid Test Kit98/79	– 98/79	EUDAMED record Report an error
Candida albicans	W0105060302	Candida albicans Ag Rapid Test Kit GKPD13598/79	– 98/79	EUDAMED record Report an error
Chemistry analysers - consumables	W0201010185	Dry Fluorescence Immunoassay Analyzer GKYG-500、GKYG-600、GKYG-800、GKYG-1000、GKYG-2000、GKYG-3000	A IVDR	EUDAMED record Report an error
Chlamydia pneumoniae antibody assays total	W0105010113	Chlamydia pneumoniae IgM/IgG Ab Rapid Test Kit GKPD10498/79	– 98/79	EUDAMED record Report an error
Coronavirus / influenza - RT & POC	W0105090601	SARS-CoV-2 & Influenza A/B Ag Detection Kit (Immunofluorescence Chromatography)98/79	– 98/79	EUDAMED record Report an error
General coagulation tests - other	W0103020199	D-Dimer Quantitative Test Kit (Quantum Dot Fluorescence Immunochromatography) 25 tests/kit98/79	– 98/79	EUDAMED record Report an error
Gonococcal antibody assays total	W0105010202	Neisseria gonorrhoeae Ag Detection Kit (Immunofluorescence Chromatography)98/79	– 98/79	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	H.Pylori Ag Rapid Test Kit GKPD12998/79	– 98/79	EUDAMED record Report an error
H. pylori antibody assays	W0105010402	H.pylori Ab Detection Kit (Immunofluorescence Chromatography)98/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Influenza A/B Ag Detection Kit (Immunofluorescence Chromatography)98/79	– 98/79	EUDAMED record Report an error
Legionella - RT & POC	W0105090108	Legionella pneumophila Ag Rapid Test Kit98/79	– 98/79	EUDAMED record Report an error
Mycoplasma antibody assays	W0105010802	Mycoplasma pneumoniae IgG/IgM Ab Rapid Test Kit GKPD10398/79	– 98/79	EUDAMED record Report an error
Salmonella antigen detection	W0105011001	Salmonella Ag Rapid Test Kit GKPD12698/79	– 98/79	EUDAMED record Report an error
Strep. b - RT & POC	W0105090104	Group B Streptococcus Rapid Test Kit98/79	– 98/79	EUDAMED record Report an error
Strep. pneumoniae - RT & POC	W0105090109	Streptococcus pneumoniae Ag Rapid Test Kit98/79	– 98/79	EUDAMED record Report an error
Syphilis antibody assays total	W0105010302	Treponema pallidum (TP) Antibody Detection Kit (Immunofluorescence Chromatography)98/79	– 98/79	EUDAMED record Report an error
Toxoplasma antibody (total)	W0105050101	Toxoplasma gondii IgG/IgM Ab Rapid Test Kit98/79	– 98/79	EUDAMED record Report an error
Trichomonas	W0105050210	Trichomonas vaginalis Ag Rapid Test Kit GKPD13798/79	– 98/79	EUDAMED record Report an error
Various general purpose IVD instruments - other	W02079099	Fully automatic pathological slide scanning analyzer GK-APSSA8300、GK-APSSA8500、GK-APSSA8600	A IVDR	EUDAMED record Report an error
Zika virus	W0105040630	Zika Virus IgG/IgM Antibody Rapid Test Kit GKPD12098/79	– 98/79	EUDAMED record Report an error

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