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Dezhou Guoke Medical Technology Co., Ltd.

China·CN-MF-000044128

Last updated June 8, 2026

Information

Country
China
Address
6596, 28-31 axis.1 and 2 span.No.2 workshop, (Zhongyuan Science and Technology Innovation Park) No.6596 Dongfanghong East Road, Yuanqiao Town, Economic and Technological Development Zone, Dezhou City, Shandong Province, China
LinkedIn
—
Facebook
—
Phone
—
PRRC Contact
xin song
EUDAMED SRN
CN-MF-000044128
FDA FEI Number
—
DUNS Number
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Catalogue (163)

Page 3 of 4
DeviceModel / ReferenceRegistriesClassStatus
SARS-CoV-2&Respiratory Syncytial Virus&Flu A & Flu B Antigen Rapid Test Cassette(Colloidal Gold) GKPD028
EUDAMED
IVD GeneralActive
Dengue Virus IgG/IgM/NS1 & Chikungunya Virus IgM/IgG Combo Rapid Test Kit GKPD116
EUDAMED
IVD GeneralActive
RSV Antigen Rapid Test Cassette (ColloidalGold) GKPD022
EUDAMED
IVD GeneralActive
Beta 2-microglobulin (β2-MG) Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography) GKPD069
EUDAMED
IVD GeneralActive
Fully Auto 5-Part Hematology Analyzer GKPD082
EUDAMED
Class BActive
NT-proBNP Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography GKPD057
EUDAMED
IVD GeneralActive
S100β Protein Detection Kit (Immunofluorescence Chromatography) GKPD196
EUDAMED
IVD GeneralActive
Glycosylated Hemoglobin (HbA1c) Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography) GKPD066
EUDAMED
IVD GeneralActive
Mycoplasma pneumoniae IgG/IgM Ab Rapid Test Kit GKPD103
EUDAMED
IVD GeneralActive
CRP/ SAA Detection Kit (Immunofluorescence Chromatography) GKPD162
EUDAMED
IVD GeneralActive
CA19-9 Detection Kit (Immunofluorescence Chromatography) GKPD187
EUDAMED
IVD GeneralActive
Heart-type Fatty Acid Binding Protein (H-FABP) Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography) GKPD058
EUDAMED
IVD GeneralActive
FSH Detection Kit (Immunofluorescence Chromatography) GKPD173
EUDAMED
IVD GeneralActive
Streptococcus pneumoniae Ag Rapid Test Kit GKPD105
EUDAMED
IVD GeneralActive
Neisseria Gonorrheae(NGH) AntigenRapid TestStrip(ColloidalGold) GKPD025
EUDAMED
IVD GeneralActive
Human β - amyloid protein (Aβ1-42) Rapid Test Kit GKPD145
EUDAMED
IVD GeneralActive
Influenza A/B, SARS-CoV-2, RSV, Adenovirus, Measles Virus, Mumps Virus and HPIV Antigen Combo Rapid Test Kit GKPD111
EUDAMED
IVD GeneralActive
Plasmodium falciparum and Pan-plasmodium Antigen Detection Kit (Immunofluorescence Chromatography) GKPD159
EUDAMED
IVD GeneralActive
Mycoplasma pneumoniae Ab Detection Kit (Immunofluorescence Chromatography) GKPD150
EUDAMED
IVD GeneralActive
Vaginal Microbial Immunofluorescence Staining Reagent GKPD005
EUDAMED
Class AActive
Plasmodium falciparum and Plasmodium vivax Antigen Detection Kit (Immunofluorescence Chromatography) GKPD160
EUDAMED
IVD GeneralActive
Influenza A/B & RSV & Adenovirus & hMPV & PIV & M. pneumoniae Ag Combo Rapid Test Kit GKPD109
EUDAMED
IVD GeneralActive
FOB/TRF/HP Rapid Test Cassette(Colloidal Gold GKPD038
EUDAMED
IVD GeneralActive
CEA Detection Kit (Immunofluorescence Chromatography) GKPD182
EUDAMED
IVD GeneralActive
CA125 Detection Kit (Immunofluorescence Chromatography) GKPD188
EUDAMED
IVD GeneralActive
Zika Virus IgG/IgM Antibody Rapid Test Kit GKPD120
EUDAMED
IVD GeneralActive
Syphilis (Tp) Ab Rapid Test Cassette (Colloidal Gold) GKPD042
EUDAMED
IVD GeneralActive
Trichomonas vaginalis Ag Rapid Test Kit GKPD137
EUDAMED
IVD GeneralActive
IGFBP-1 Rapid Test Kit GKPD142
EUDAMED
IVD GeneralActive
Malaria P.f/P.v Ag Rapid Test Kit GKPD114
EUDAMED
IVD GeneralActive
Dengue NS1 Detection Kit (Immunofluorescence Chromatography) GKPD155
EUDAMED
IVD GeneralActive
Adenovirus IgM Ab Rapid Test Kit GKPD100
EUDAMED
IVD GeneralActive
PCT / IL-6 Detection Kit (Immunofluorescence Chromatography) GKPD164
EUDAMED
IVD GeneralActive
SARS-CoV-2 & Influenza A/B Ag Detection Kit (Immunofluorescence Chromatography) GKPD146
EUDAMED
IVD GeneralActive
Microalbuminuria (MAU) Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography) GKPD053
EUDAMED
IVD GeneralActive
tPSA Detection Kit (Immunofluorescence Chromatography) GKPD185
EUDAMED
IVD GeneralActive
Salmonella Ag Rapid Test Kit GKPD126
EUDAMED
IVD GeneralActive
Cystatin C (Cys-C) Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography) GKPD068
EUDAMED
IVD GeneralActive
Progesterone (Prog) Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography) GKPD063
EUDAMED
IVD GeneralActive
25-hydroxyvitamin D (25-OH-D) Quantitative Test Cassette (Quantum Dot Fluorescence Immunochromatography) GKPD052
EUDAMED
IVD GeneralActive
Insulin Detection Kit (Immunofluorescence Chromatography) GKPD165
EUDAMED
IVD GeneralActive
Chlamydia pneumoniae IgM/IgG Ab Rapid Test Kit GKPD104
EUDAMED
IVD GeneralActive
Gastrin-17 Detection Kit (Immunofluorescence Chromatography) GKPD176
EUDAMED
IVD GeneralActive
Adenovirus Antigen Rapid Test Cassette (Colloidal Gold) GKPD040
EUDAMED
IVD GeneralActive
MERS-CoV Antigen Rapid Test Kit GKPD125
EUDAMED
IVD GeneralActive
FT3 Detection Kit (Immunofluorescence Chromatography) GKPD169
EUDAMED
IVD GeneralActive
Enterovirus 71 (EV71) and Coxsackievirus A16 (CA16) Antigen Combo Rapid Test Kit GKPD128
EUDAMED
IVD GeneralActive
Nipah Virus Ag Rapid Test Kit GKPD112
EUDAMED
IVD GeneralActive
Folic Acid Detection Kit (Immunofluorescence Chromatography) GKPD192
EUDAMED
IVD GeneralActive
VB12 Detection Kit (Immunofluorescence Chromatography) GKPD191
EUDAMED
IVD GeneralActive

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