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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 6 of 6

Device	Model / Reference	Registries	Class	Status
Thyroid-Peroxidase Antibody assay (CLIA)	7B08V1-B-EU, 7B08U1-B-EU, 7B08P1-B-EU	EUDAMED	IVD General	Active
Rapid Rotavirus Antigen Test Card	1N07C4	EUDAMED	IVD General	Active
Colloidal Gold Immunoassay Analyzer	CG-300	EUDAMED	Class A	Active
Alpha-Fetoprotein Test (FIA)	5C01C1-25-EU, 5C01C1-50-EU	EUDAMED	IVD General	Active
Luteinizing Hormone Test (FIA)	5D02C1-25-EU, 5D02C1-50-EU	EUDAMED	IVD General	Active
Rapid DOA-3 Panel Test	1L19M3	EUDAMED	IVD General	Active
Rapid AB-PINACA Test	1L61C3-1-EU, 1L61C3-25-EU,1L61S3-1-EU, 1L61S3-50-EU	EUDAMED	IVD General	Active
Rapid D-Dimer Test Card	1M21C2	EUDAMED	IVD General	Active
Prolactin Test (FIA)	5D03C1-25-EU, 5D03C1-50-EU	EUDAMED	IVD General	Active
HbA1c assay (CLIA)	7M22V1-B-EU, 7M22U1-B-EU, 7M22E1-B-EU	EUDAMED	IVD General	Active
Rapid DOA-12 Panel Test Cup (Split type)	1L34P3	EUDAMED	IVD General	Active
Rapid SARS-CoV-2 Antigen Test Card	1N40C5	EUDAMED	IVD General	Active
Rapid Rheumatoid Factor Test Card	1M27C2	EUDAMED	IVD General	Active
Squamous Cell Carcinoma assay (CLIA)	7C21V1-B-EU, 7C21U1-B-EU, 7C21P1-B-EU	EUDAMED	IVD General	Active
Troponin T Quantitative Test	5J09C1	EUDAMED	IVD General	Active
Rapid SARS-CoV-2 Antigen Test Card	1N40C5-9	EUDAMEDFDA UDI	IVD devices for self-testing	Active
Progastrin-Releasing Peptide assay (CLIA)	7C22V1-B-EU, 7C22U1-B-EU, 7C22P1-B-EU	EUDAMED	IVD General	Active
Pepsinogen I assay (CLIA)	7C16V1-B-EU, 7C16U1-B-EU, 7C16P1-B-EU	EUDAMED	IVD General	Active
Rapid Buprenorphine Test Card	1L04C3	EUDAMED	IVD General	Active
Rapid Tramadol Test Card	1L31C3	EUDAMED	IVD General	Active
Thyroid Stimulating Hormone Test (FIA)	5B01C1-25-EU, 5B01C1-50-EU	EUDAMED	IVD General	Active
Rapid DOA-7 Panel Test Card	1L23C3	EUDAMED	IVD General	Active
Serum Amyloid A assay (CLIA)	7M24V1-B-EU, 7M24U1-B-EU, 7M24P1-B-EU	EUDAMED	IVD General	Active
Rapid Gabapentin Test	1L82C3-1-EU, 1L82C3-25-EU, 1L82S3-1-EU, 1L82S3-50-EU	EUDAMED	IVD General	Active
Luteinizing Hormone assay (CLIA)	7D02V1-B-EU, 7D02U1-B-EU, 7D02P1-B-EU	EUDAMED	IVD General	Active
Rapid THC Test Card	1L14C3	EUDAMED	IVD General	Active
Rapid SARS-CoV-2/Influenza A+B Antigen Duo Test Card	1N41C5-27	EUDAMED	IVD General	Active
Rapid DOA-9 Panel Test Cup (Split type)	1L25P3	EUDAMED	IVD General	Active
Rapid DOA-4 Panel Test	1L20M3	EUDAMED	IVD General	Active
Rapid Fecal Occult Blood Test Card	1M01C4	EUDAMED	IVD General	Active
Rapid DOA-2 Panel Test Card	1L18C3	EUDAMED	IVD General	Active
Rapid H.Pylori Antigen Test Card	1O03C4	EUDAMED	IVD General	Active
Rapid Adeno/Rota Virus Antigen Combo Test Card	1N08C4	EUDAMED	IVD General	Active
Rapid NT-proBNP Test Card	1J07C2	EUDAMED	IVD General	Active
Rapid Benzodiazepine Test Strip	1L03S3	EUDAMED	IVD General	Active
Rapid SARS-CoV-2/Flu A+B/RSV/ADV Antigen Test Card	1N44C5	EUDAMED	IVD General	Active
Rapid DOA-10 Panel Test Cup	1L26K3	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