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BEIJING HOTGEN BIOTECH CO., LTD.

China·CN-MF-000015566

Last updated September 17, 2026

Information

Country: China
Address: 1-5 floor, 7th Building No.55 Qingfeng West Road, Daxing Biomedical Base Zhongguancun Science Park Daxing District Beijing 102629 China, Beijing, China
Website: hotgen.com.cn
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +86 400-815-1117
PRRC Contact: Wei Min
EUDAMED SRN: CN-MF-000015566
FDA FEI Number: 3017894300
DUNS Number: —

Catalogue (62)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
25-hydroxy-vitamin D test (Chemiluminescence Immunoassay)	HGCL11	EUDAMED	Class B	Active
Prolactin test (Chemiluminescence Immunoassay)	HGCL17	EUDAMED	Class B	Active
Estradiol test (Up-converting Phosphor Technology)	HGUPT34	EUDAMED	Class B	Active
Testosterone test (Chemiluminescence Immunoassay)	HGCL19	EUDAMED	Class B	Active
High sensitive Cardiac Troponin-I test (Chemiluminescence Immunoassay)	HGCL01	EUDAMED	Class C	Active
Cytokeratin 19 Fragments test (Chemiluminescence Immunoassay)	HGCL25	EUDAMED	Class C	Active
C reactive protein test (Up-converting Phosphor Technology)	HGUPT01	EUDAMED	Class C	Active
Ferritin test(Chemiluminescence Immunoassay)	HGCL31	EUDAMED	Class B	Active
α-fetoprotein test (Up-converting Phosphor Technology)	HGUPT17	EUDAMED	Class C	Active
Free Thyroxine test (Chemiluminescence Immunoassay)	HGCL43	EUDAMED	Class B	Active
N-terminal Pro-B-type Natriuretic Peptide test (Up-converting Phosphor Technology)	HGUPT06	EUDAMED	Class C	Active
Free Triiodothyronine test (Up-converting Phosphor Technology)	W01020401	EUDAMED	Class B	Active

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FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Beijing Hotgen Biotech Co., Ltd. US