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XIAMEN BOSON BIOTECH CO., LTD.

China·CN-MF-000001096

Last updated September 17, 2026

Information

Country: China
Address: No. 90-94, Tianfeng Road, Xiamen, China
Website: www.bosonbio.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +86-592-3965101
PRRC Contact: Haolong Shen
EUDAMED SRN: CN-MF-000001096
FDA FEI Number: 3008825965
DUNS Number: —

Catalogue (287)

Page 5 of 6

Device	Model / Reference	Registries	Class	Status
Rapid Tuberculosis Test Card-Serum	1O01C1	EUDAMED	IVD General	Active
Progesterone assay (CLIA)	7E01V1-B-EU, 7E01U1-B-EU, 7E01P1-B-EU	EUDAMED	IVD General	Active
Rapid V.Cholerae O1/O139 Duo Test Card	1O17C4	EUDAMED	IVD General	Active
Rapid DOA-4 Panel Test Cup	1L20K3	EUDAMED	IVD General	Active
Free Triiodothyronine Test (FIA)	5B03C1-25-EU, 5B03C1-50-EU	EUDAMED	IVD General	Active
Treponema Pallidum Antibody assay (CLIA)	7N02V1-B-EU, 7N02U1-B-EU, 7N02P1-B-EU	EUDAMED	IVD General	Active
Helicobacter Pylori IgG assay (CLIA)	7O02V1-B-EU, 7O02U1-B-EU, 7O02P1-B-EU	EUDAMED	IVD General	Active
25-Hydroxy Vitamin D Test (FIA)	5M12C2-25-EU, 5M12C2-50-EU	EUDAMED	IVD General	Active
Rapid DOA-10 Panel Test Cup (Split type)	1L26P3	EUDAMED	IVD General	Active
Folate assay (CLIA)	7M38V1-B-EU, 7M38U1-B-EU, 7M38P1-B-EU	EUDAMED	IVD General	Active
Rapid Phencyclidine Test Strip	1L13S3	EUDAMED	IVD General	Active
Rapid DOA-8 Panel Test Cup	1L24K3	EUDAMED	IVD General	Active
Rapid Benzodiazepine Test Card	1L03C3	EUDAMED	IVD General	Active
Dengue NS1 Antigen Test (FIA)	5N23C1-25-EU, 5N23C1-50-EU	EUDAMED	IVD General	Active
Rapid DOA-5 Panel Test Cup	1L21K3	EUDAMED	IVD General	Active
Free Thyroxine Test (FIA)	5B02C1-25-EU, 5B02C1-50-EU	EUDAMED	IVD General	Active
Rapid Heroin Test	1L74C3-1-EU, 1L74C3-25-EU,1L74S3-1-EU, 1L74S3-50-EU	EUDAMED	IVD General	Active
Rapid Propoxyphene Test Card	1L30C3	EUDAMED	IVD General	Active
Ferritin Test (FIA)	5C07C1-25-EU, 5C07C1-50-EU	EUDAMED	IVD General	Active
Rapid Barbiturate Test Strip	1L02S3	EUDAMED	IVD General	Active
Rapid DOA-12 Panel Test Cup	1L34K3	EUDAMED	IVD General	Active
Rapid DOA-6 Panel Test Cup (Split type)	1L22P3	EUDAMED	IVD General	Active
IGFBP-3 assay (CLIA)	7F07V1-B-EU, 7F07U1-B-EU, 7F07P1-B-EU	EUDAMED	IVD General	Active
Rapid C-reactive Protein Test Card	1M13C2	EUDAMED	IVD General	Active
Microalbumin Test (FIA)	5M23C3-25-EU, 5M23C3-50-EU	EUDAMED	IVD General	Active
Troponin T Test (FIA)	5J09C1-25-EU, 5J09C1-50-EU	EUDAMED	IVD General	Active
Rapid Fentanyl Test Strip	1L35S3	EUDAMED	IVD General	Active
Hypersensitive C-reactive Protein assay (CLIA)	7J05V1-B-EU, 7J05U1-B-EU, 7J05P1-B-EU	EUDAMED	IVD General	Active
Rapid HPIV Antigen Test	1N59C5-1-EU,1N59C5-20-EU	EUDAMED	IVD General	Active
Rapid H.Pylori Antigen Test Card (3mm)	1O03C42	EUDAMED	IVD General	Active
Rapid Flu A+B/RSV Antigen Test Card	1N48C5-1-EU, 1N48C5-20-EU	EUDAMED	IVD General	Active
Ferritin assay (CLIA)	7C07V1-B-EU, 7C07U1-B-EU, 7C07P1-B-EU	EUDAMED	IVD General	Active
Rapid Malaria pf/pan Antigen Test Card	1Q10C2	EUDAMED	IVD General	Active
Rapid SARS-CoV-2/Flu A+B/RSV Antigen Test Card	1N45C5	EUDAMED	IVD General	Active
Rapid Norfentanyl Test	1L79C3-1-EU, 1L79C3-25-EU, 1L79S3-1-EU, 1L79S3-50-EU	EUDAMED	IVD General	Active
Rapid β2-Microglobulin Test Card	1M19C2	EUDAMED	IVD General	Active
Rapid Methaqualone Test Card	1L52C3	EUDAMED	IVD General	Active
Rapid Codeine Test	1L75C3-1-EU, 1L75C3-25-EU,1L75S3-1-EU, 1L75S3-50-EU	EUDAMED	IVD General	Active
Rapid Cardiac Panel Test Card	1J04C2	EUDAMED	IVD General	Active
Marijuana(THC) Saliva Test Card	1L14C5	EUDAMED	IVD General	Active
Interleukin-6 Test (FIA)	5M20C2-25-EU, 5M20C2-50-EU	EUDAMED	IVD General	Active
Cancer Embryo Antigen Test (FIA)	5C02C1-25-EU, 5C02C1-50-EU	EUDAMED	IVD General	Active
Rapid DOA-8 Panel Test	1L24M3	EUDAMED	IVD General	Active
Creatine Kinase-MB Test (FIA)	5J01C1-25-EU, 5J01C1-50-EU	EUDAMED	IVD General	Active
Rapid DOA-9 Panel Test Cup	1L25K3	EUDAMED	IVD General	Active
Rapid Clonazepam Test Card	1L45C3	EUDAMED	IVD General	Active
Myoglobin Test (FIA)	5J03C1-25-EU, 5J03C1-50-EU	EUDAMED	IVD General	Active
Rapid 2019-nCoV IgG/IgM Combo Test Card	1N38C2	EUDAMED	IVD General	Active
Rapid DOA-7 Panel Test	1L23M3	EUDAMED	IVD General	Active
Rapid AFP Test Card	1C01C2	EUDAMED	IVD General	Active

Related Companies

Authorised Representatives

Lotus NL B.V. NL
MedPath GmbH DE

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (1)

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

Xiamen Boson Biotech Co., Ltd. US