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Shanghai BioGerm Medical Technology Co., Ltd.

China·CN-MF-000018164

Last updated June 8, 2026

Information

Country: China
Address: Room 407, 4th Floor, No. 5, Lane 600, Yunling West Road, Putuo District, Shanghai, China
Website: boke.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +86 18066288005
PRRC Contact: binsheng wang
EUDAMED SRN: CN-MF-000018164
FDA FEI Number: —
DUNS Number: —

Catalogue (17)

Device	Model / Reference	Registries	Class	Status
SARS-CoV-2 /Flu A / Flu B/RSV/ADV/MP Antigen Rapid Test Kit	IS-MY-025-1	EUDAMED	IVD General	Active
Mycoplasma pneumoniae IgM Antibody Rapid Test Kit	IS-MY-016-1	EUDAMED	IVD General	Active
Mycoplasma pneumoniae IgM Antibody Rapid Test Kit	IS-MY-016-5	EUDAMED	IVD General	Active
Mycoplasma pneumoniae IgM Antibody Rapid Test Kit	IS-MY-016-50	EUDAMED	IVD General	Active
Mycoplasma pneumoniae IgM Antibody Rapid Test Kit	IS-MY-016-20	EUDAMED	IVD General	Active
Norovirus Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing)	IS-FZ-020-50	EUDAMED	IVD General	Active
Enterovirus Universal Nucleic Acid Detection Kit(PCR-Fluorescence Probing)	IS-FZ-032-25	EUDAMED	IVD General	Active
Respiratory Syncytial Virus/HumanParainfluenza Virus /Human Rhinovirus Nucleic Acid Detection Kit (Fluorescent RT-MIRA)	IS-FZ-029-24-1	EUDAMED	IVD General	Active
Enterovirus Universal Nucleic Acid Detection Kit(PCR-Fluorescence Probing)	IS-FZ-032-96	EUDAMED	IVD General	Active
Influenza A/B virus Antigen Rapid Test Kit	IS-MY-015-1	EUDAMED	IVD General	Active
Influenza A/B & RSV Nucleic Acid Detection Kit (Fluorescent RT-MIRA)	IS-FZ-034-24-1	EUDAMED	IVD General	Active
SARS-CoV-2 /Influenza A/B virus antigen Rapid Test kit	IS-MY-010-50	EUDAMED	IVD General	Active
Monkeypox Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing)	IS-FZ-064-25-CE	EUDAMED	Class C	Active
Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (Fluorescent RT-MIRA)	ZC-HX-203-1	EUDAMED	IVD General	Active
Boke	001	EUDAMED	Class I	Active
Nucleic acid extraction and purification kit	TQ-BG-008-96D-96	EUDAMED	Class A	Active
Automatic Nucleic Acid Purification Instrument	E-96	EUDAMED	Class A	Active
Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing)	ZC-HX-201-3	EUDAMED	IVD General	Active

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