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Daan Gene Co., Ltd.

China·CN-MF-000025799

Last updated June 8, 2026

Information

Country: China
Address: No. 19, Xiangshan Road, Science Park, High & New Technology Development District, Guangzhou, China
Website: daangene.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: —
PRRC Contact: Jie Huang
EUDAMED SRN: CN-MF-000025799
FDA FEI Number: —
DUNS Number: —

Catalogue (127)

Page 2 of 3

Device	Model / Reference	Registries	Class	Status
Detection Kit for 2019-nCoV (PCR-Fluorescence)	DA1074	EUDAMED	IVD General	Active
Nucleic Acid Extraction Kit	DA1002-1	EUDAMED	Class A	Active
Detection Kit for Chlamydia trachomatis Nucleic Acid (PCR-Fluorescence Probing)	DA1141	EUDAMED	IVD Annex II List B	Active
Detection Kit for Norovirus RNA (PCR-Fluorescence Probing)	DA1151	EUDAMED	IVD General	Active
RNA/DNA Extraction or Purification Kit	DA0662	EUDAMED	Class A	Active
RNA/DNA Purification Kit (Preservation)	DA0943	EUDAMED	Class A	Active
RNA/DNA Purification Kit (Preservation/Release)	DA0960	EUDAMED	Class A	Active
Nucleic Acid Extraction Kit	DA1004	EUDAMED	Class A	Active
Nucleic Acid Extraction Kit	DA0601	EUDAMED	Class A	Active
Automatic Nucleic Acid Extraction Instrument	DA8044	EUDAMED	Class A	Active
Detection Kit for Influenza A Virus H1N1 (IVA H1N1) (2009) RNA (PCR-Fluorescence Probing)	DA0220	EUDAMED	IVD General	Active
Diagnostic Kit for Quantification of Hepatitis B Virus DNA (PCR-Fluorescence Probing)	DA0041	EUDAMED	IVD Annex II List A	Active
Detection Kit for SARS-CoV-2 UK and South African Variants (PCR-Fluorescence)	DA1060	EUDAMED	IVD General	Active
Nucleic Acid Extraction Kit	DA1001	EUDAMED	Class A	Active
Detection Kit for Mycobacterium Tuberculosis Complex Nucleic Acid (PCR-Fluorescence Probing)	DA1242	EUDAMED	IVD General	Active
Rapid Detection System	DA8130	EUDAMED	Class A	Active
Detection Kit for Avian Influenza (H7N9) Virus RNA (PCR-Fluorescence Probing)	DA0550	EUDAMED	IVD General	Active
Diagnostic Kit for Mycobacterium Tuberculosis DNA (PCR-Fluorescence)	DA0050	EUDAMED	IVD General	Active
Diagnostic Kit for Quantification of Hepatitis C Virus RNA (PCR -Fluorescence Probing)	DA0182	EUDAMED	IVD Annex II List A	Active
Detection Kit for Mycobacterium Tuberculosis Complex Nucleic Acid (PCR-Fluorescence Probing)	DA1240	EUDAMED	IVD General	Active
RNA/DNA Purification Kit (Release)	DA0952	EUDAMED	Class A	Active
Nucleic Acid Isolation or Purification Reagent	DA0621	EUDAMED	Class A	Active
RNA/DNA Purification Kit (Preservation)	DA1480	EUDAMED	Class A	Active
Detection Kit for 2019-nCoV (PCR-Fluorescence)	DA1070	EUDAMED	IVD General	Active
Detection Kit for 2019-nCoV (N/E/RDRP Gene)	DA1170	EUDAMED	IVD General	Active
Nucleic Acid Isolation or Purification Kit	DA0872	EUDAMED	Class A	Active
Nucleic Acid Isolation or Purification Reagent	DA0623	EUDAMED	Class A	Active
RNA/DNA Purification Kit (Magnetic Bead)	DA0634	EUDAMED	Class A	Active
Detection Kit for Influenza A/B and 2019-nCoV (PCR-Fluorescence Probing)	DA1041	EUDAMED	IVD General	Active
RNA/DNA Purification Kit (Preservation)	DA0945	EUDAMED	Class A	Active
Diagnostic Kit for Quantification of Neisseria Gonorrhoeae (PCR-Fluorescence Probing)	DA0063	EUDAMED	IVD General	Active
Detection Kit for Zika Virus RNA (PCR-Fluorescence Probing)	DA0711	EUDAMED	IVD General	Active
Nucleic Acid Isolation or Purification Kit	DA0873	EUDAMED	Class A	Active
Detection Kit for Mycobacterium Tuberculosis Complex Nucleic Acid (PCR-Fluorescence Probing)	DA1241	EUDAMED	IVD General	Active
Specimen Preservation Reagent	DA0975	EUDAMED	Class A	Active
Epstein-Barr Virus (EBV) Polymerase Chain Reaction (PCR) Fluorescence Quantitative Diagnostic Kit	DA0153	EUDAMED	IVD General	Active
2019-nCoV Omicron Variant Detection Kit (PCR-Fluorescence)	DA1221	EUDAMED	IVD General	Active
Nucleic Acid Extraction Kit	DA1002	EUDAMED	Class A	Active
RNA/DNA Extraction or Purification Kit	DA1274	EUDAMED	Class A	Active
Detection Kit for 2019-nCoV Nucleic Acid (Thermostatic Amplification-LFIA)	DA1390	EUDAMED	IVD General	Active
RNA/DNA Purification Kit (Preservation)	DA0940	EUDAMED	Class A	Active
Diagnostic Kit for Human Influenza Virus Subtype H1 RNA (PCR-Fluorescence Probing)	DA0290	EUDAMED	IVD General	Active
Detection Kit for Epstein-Barr Virus Nucleic Acid (PCR-Fluorescence Probing)	DA1251	EUDAMED	IVD General	Active
RNA/DNA Purification Kit (Release)	DA0951	EUDAMED	Class A	Active
Specimen Preservation Solution	DA0982	EUDAMED	Class A	Active
Automatic Nucleic Acid Extraction Instrument	DA8045	EUDAMED	Class A	Active
Diagnostic Kit for Ureaplasma Urealyticum DNA (PCR-Fluorescence Probing)	DA0083	EUDAMED	IVD General	Active
RNA/DNA Extraction or Purification Kit	DA0640	EUDAMED	Class A	Active
Specimen Preservation Reagent	DA0972	EUDAMED	Class A	Active
Detection Kit for Respiratory Syncytial Virus RNA (PCR-Fluorescence Probing)	DA0201	EUDAMED	IVD General	Active

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