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Dynamiker Biotechnology (Tianjin) Co., Ltd.

China·CN-MF-000001133

Last updated September 17, 2026

Information

Country
China
Address
No.2 Building, Rongzhi Industry Park, No. 3667, Zhongbin Avenue, Sino-Singapore Eco-city, TEDA, Tianjin, China
LinkedIn
—
Facebook
—
Phone
+86 22 2526 4212
PRRC Contact
Zeqi Zhou
EUDAMED SRN
CN-MF-000001133
FDA FEI Number
3012452932
DUNS Number
—

Catalogue (152)

Page 1 of 4
DeviceModel / ReferenceRegistriesClassStatus
MycoMDx Mucor Cartridge PCR Assay DNK-2604-2
EUDAMED
IVD GeneralActive
MicroMDx Carbapenem resistance gene Cartridge PCR Assay DNK-2607-2
EUDAMED
IVD GeneralActive
MycoMDx Candida Cartridge PCR Assay DNK-2602-2
EUDAMED
IVD GeneralActive
MycoMDx Mucor Cartridge PCR Assay DNK-2604-1
EUDAMED
IVD GeneralActive
MycoMDx Talaromyces marneffei Cartridge PCR Assay DNK-2606-1
EUDAMED
IVD GeneralActive
MycoMDx Talaromyces marneffei Cartridge PCR Assay DNK-2606-2
EUDAMED
IVD GeneralActive
MycoMDx Aspergillus Cartridge PCR Assay DNK-2601-1
EUDAMED
IVD GeneralActive
MicroMDx Carbapenem resistance gene Cartridge PCR Assay DNK-2607-1
EUDAMED
IVD GeneralActive
MycoMDx Pneumocystis jirovecii Cartridge PCR Assay DNK-2605-2
EUDAMED
IVD GeneralActive
Flu A/Flu B/MP Multiplex Real-time PCR Kit DNK-2511-1
EUDAMED
IVD GeneralActive
Dynamiker HRV / HMPV / MP / ADV Antigens Combo Test Kit(LFA) DNK-2509-1
EUDAMED
IVD GeneralActive
MycoMDx Cartridge PCR Assay for Detection of 3 Fungal Pathogens DNK-2608-2
EUDAMED
IVD GeneralActive
Helicobacter pylori IgG antibody test kit (LFA) DNK-2503-1
EUDAMED
IVD GeneralActive
MycoMDx Cartridge PCR Assay for Detection of 3 Fungal Pathogens DNK-2608-1
EUDAMED
IVD GeneralActive
MycoMDx Candida Cartridge PCR Assay DNK-2602-1
EUDAMED
IVD GeneralActive
MycoMDx Pneumocystis jirovecii Cartridge PCR Assay DNK-2605-1
EUDAMED
IVD GeneralActive
MycoMDx Candida auris Cartridge PCR Assay DNK-2603-2
EUDAMED
IVD GeneralActive
HAdV/HRV/RSV Multiplex Real-time PCR Kit DNK-2512-1
EUDAMED
IVD GeneralActive
MycoMDx Candida auris Cartridge PCR Assay DNK-2603-1
EUDAMED
IVD GeneralActive
Dynamiker Cryptococcal antigen Assay(Chemiluminescence) DNK-1901-27
EUDAMED
IVD GeneralActive
MycoMDx Candida auris PCR Assay DNK-2107-1
EUDAMED
IVD GeneralActive
Endotoxin LPS Control DNK-1901-5
EUDAMED
IVD GeneralActive
Endotoxin LPS Control DNK-1901-5
EUDAMED
IVD GeneralActive
2019-nCOV IgM Antibody kit (Chemiluminescence) DNK-1423-1
EUDAMED
IVD GeneralActive
Dynamiker COVID-19/Influenza A+B Ag Combo Rapid Test DNK-2104-1
EUDAMED
IVD GeneralActive
MycoMDx Carbapenem resistance gene Assay (F-PCR) DNK-1901-20
EUDAMED
IVD GeneralActive
Dynamiker Fungal Nucleic Acid Extraction Kit DNK-1901-23
EUDAMED
IVD GeneralActive
Fungus (1-3)-β-D Glucan Control DNK-1901-2
EUDAMED
IVD GeneralActive
Dynamiker Candida albicans IgG Assay (POCT Chemiluminescence) DNK-1901-61
EUDAMED
IVD GeneralActive
MycoMDx Candida PCR Assay DNK-1417-1
EUDAMED
IVD GeneralActive
Dynamiker Influenza A+B /RSV Ag Combo Rapid Test DNK-2116-1
EUDAMED
IVD GeneralActive
Dynamiker Mycoplasma Pneumoniae Antigen Test Kit (LFA) DNK-2507-1
EUDAMED
IVD GeneralActive
Dynamiker Fungus (1-3)-β-D-Glucan Assay (ELISA) DNK-2201-1
EUDAMED
IVD GeneralActive
Dynamiker Gram Negative Bacterial Endotoxin Assay(Chromogenic) DNK-1901-4
EUDAMED
IVD GeneralActive
Dynamiker Adenovirus Antigen Test Kit (LFA) DNK-2506-1
EUDAMED
IVD GeneralActive
Dynamiker Gram Negative Bacterial Endotoxin Assay(Chromogenic) DNK-1901-4
EUDAMED
IVD GeneralActive
Dynamiker Candida albicans IgG Assay DNK-1409-1
EUDAMED
IVD GeneralActive
QuicNATM SARS-CoV-2 Neutralization Ab Lateral Flow Assay DNK-1901-10
EUDAMED
IVD GeneralActive
Carbapenem Resistant Enterobacteriaceae Test Kit (LFA) DNK-2302-1
EUDAMED
IVD GeneralActive
QuicNATM SARS-CoV-2 Neutralization Ab Lateral Flow Assay DNK-1901-10
EUDAMED
IVD GeneralActive
Dynamiker SARS-CoV-2 Ag Rapid Test (POCT Chemiluminescence) DNK-1901-57
EUDAMED
IVD GeneralActive
Endotoxin LPS Control DNK-1901-5
EUDAMED
IVD GeneralActive
Dynamiker Candida Mannan Assay (POCT Chemiluminescence) DNK-1901-59
EUDAMED
IVD GeneralActive
Dynamiker Influenza A Antigen Assay (Chemiluminescence) DNK-1901-42
EUDAMED
IVD GeneralActive
Dynamiker Influenza B Antigen Assay (POCT Chemiluminescence) DNK-1901-56
EUDAMED
IVD GeneralActive
Dynamiker Total IgE Ab Assay (POCT Chemiluminescence) DNK-1901-54
EUDAMED
IVD GeneralActive
Dynamiker SARS-CoV-2 Lyophilized RT-PCR Kit DNK-1901-19
EUDAMED
IVD GeneralActive
Dynamiker Aspergillus fumigatus IgG Assay DNK-1407-1
EUDAMED
IVD GeneralActive
Dynamiker SARS-CoV-2 Neutralization Antibody Rapid Test DNK-2101-1
EUDAMED
IVD GeneralActive
QuicGMTM Aspergillus Galatomannan Ag Lateral Flow Assay DNK-1414-1
EUDAMED
IVD GeneralActive

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