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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 1 of 2

Device	Model / Reference	Registries	Class	Status
Anti-thyroglobulin Antibody test (Chemiluminescence Immunoassay)	HGCL70	EUDAMED	Class B	Active
Thyroid-stimulating hormone test (Up-converting Phosphor Technology)	HGUPT26	EUDAMED	Class B	Active
Antibody to thyroid peroxidase test (Chemiluminescence Immunoassay)	HGCL69	EUDAMED	Class B	Active
Cancer Antigen 125 test (Chemiluminescence Immunoassay)	HGCL26	EUDAMED	Class C	Active
Procalcitonin test (Chemiluminescence Immunoassay)	HGCL08	EUDAMED	Class C	Active
Total Triiodothyronine test (Chemiluminescence Immunoassay)	HGCL39	EUDAMED	Class B	Active
Cancer Antigen 15-3 test (Chemiluminescence Immunoassay)	HGCL27	EUDAMED	Class C	Active
Total Triiodothyronine test (Up-converting Phosphor Technology)	HGUPT27	EUDAMED	Class B	Active
Luteinizing Hormone test (Up-converting Phosphor Technology)	HGUPT33	EUDAMED	Class B	Active
Glycosylated hemoglobin test (Up-converting Phosphor Technology)	HGUPT22	EUDAMED	Class C	Active
Anti-Mullerian hormone test (Chemiluminescence Immunoassay)	HGCL14	EUDAMED	Class B	Active
Protein Extraction Kit	HGOTHER09	EUDAMED	Class A	Active
Progesterone test (Chemiluminescence Immunoassay)	HGCL20	EUDAMED	Class B	Active
β-Human Chorionic Gonadotropin test (Chemiluminescence Immunoassay)	HGCL21	EUDAMED	Class B	Active
Procalcitonin test (Up-converting Phosphor Technology)	HGUPT04	EUDAMED	Class C	Active
Follicle-stimulating Hormone test (Up-converting Phosphor Technology)	HGUPT35	EUDAMED	Class B	Active
N-terminal Pro-B-type Natriuretic Peptide test (Chemiluminescence Immunoassay)	HGCL04	EUDAMED	Class C	Active
D-Dimer test (Chemiluminescence Immunoassay)	HGCL05	EUDAMED	Class C	Active
Estradiol test (Chemiluminescence Immunoassay)	HGCL18	EUDAMED	Class B	Active
Glycosylated Hemoglobin test (Chemiluminescence Immunoassay)	HGCL59	EUDAMED	Class C	Active
Carcinoembryonic Antigen test (Chemiluminescence Immunoassay)	HGCL23	EUDAMED	Class C	Active
Total Prostate Specific Antigen test (Chemiluminescence Immunoassay)	HGCL24	EUDAMED	Class C	Active
Squamous Cell Carcinoma Antigen test (Chemiluminescence Immunoassay)	HGCL73	EUDAMED	Class C	Active
Creatine kinase mb test (Chemiluminescence Immunoassay)	HGCL02	EUDAMED	Class C	Active
Free Triiodothyronine test (Chemiluminescence Immunoassay)	HGCL42	EUDAMED	Class B	Active
Interleukin-6 test (Chemiluminescence Immunoassay)	HGCL10	EUDAMED	Class B	Active
C-reactive protein test (Chemiluminescence Immunoassay)	HGCL09	EUDAMED	Class C	Active
Total Thyroxine test (Up-converting Phosphor Technology)	HGUPT23	EUDAMED	Class B	Active
Total β Human Chorionic Gonadotropin test (Up-converting Phosphor Technology)	HGUPT38	EUDAMED	Class B	Active
High Sensitive Troponin T test (Chemiluminescence Immunoassay)	HGCL75	EUDAMED	Class C	Active
B-type Natriuretic Peptide test (Chemiluminescence Immunoassay)	HGCL67	EUDAMED	Class C	Active
Anti-cyclic Citrullinated Peptide Antibody rapid test (Colloidal Gold)	HGCG02	EUDAMED	Class B	Active
Free Thyroxine test (Up-converting Phosphor Technology)	HGUPT25	EUDAMED	Class B	Active
Anti-Cyclic Citrullinated Peptide Antibody test (Chemiluminescence Immunoassay)	HGCL93	EUDAMED	Class B	Active
α-fetoprotein test (Chemiluminescence Immunoassay)	HGCL22	EUDAMED	Class C	Active
Folate test (Up-converting Phosphor Technology)	HGUPT36	EUDAMED	Class B	Active
Cancer Antigen 19-9 test (Chemiluminescence Immunoassay)	HGCL28	EUDAMED	Class C	Active
N-terminal Pro-B-type Natriuretic Peptide rapid test (Colloidal Gold)	HGCG01	EUDAMED	Class C	Active
Cardiac Troponin-I test (Up-converting Phosphor Technology)	HGUPT05	EUDAMED	Class C	Active
Total Thyroxine test (Chemiluminescence Immunoassay)	HGCL40	EUDAMED	Class B	Active
Anti-Mullerian Hormone Test (Up-converting Phosphor Technology)	HGUPT15	EUDAMED	Class B	Active
Myoglobin test (Chemiluminescence Immunoassay)	HGCL03	EUDAMED	Class C	Active
Vitamin B12 test (Chemiluminescence Immunoassay)	HGCL66	EUDAMED	Class B	Active
Follicle-stimulating Hormone test (Chemiluminescence Immunoassay)	HGCL15	EUDAMED	Class B	Active
25-hydroxy-vitamin D test (Up-converting Phosphor Technology)	HGUPT02	EUDAMED	Class B	Active
Automatic Chemiluminescence Immunoassay Analyzer	HGMQ60 proB	EUDAMED	Class A	Active
Luteinizing Hormone test (Chemiluminescence Immunoassay)	HGCL16	EUDAMED	Class B	Active
Human Epididymis Protein 4 test (Chemiluminescence Immunoassay)	HGCL32	EUDAMED	Class C	Active
Thyroid-stimulating Hormone test (Chemiluminescence Immunoassay)	HGCL41	EUDAMED	Class B	Active
Folate test (Chemiluminescence Immunoassay)	HGCL97	EUDAMED	Class B	Active

Related Companies

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MedNet EC-REP GmbH DE

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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