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Xiamen BioRay Biotechnology Co., Ltd.

China·CN-MF-000045502

Last updated June 8, 2026

Information

Country: China
Address: Room 101, Room 201, Room 301, No.1, Pingcheng Middle Road, Haicang District, 361026 Xiamen City, Fujian Province, PEOPLE’S REPUBLIC OF CHINA, Xiamen, China
Website: biotime.cn
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +86-15059327317
PRRC Contact: Huabin Xu
EUDAMED SRN: CN-MF-000045502
FDA FEI Number: —
DUNS Number: —

Catalogue (423)

Page 7 of 9

Device	Model / Reference	Registries	Class	Status
IL-6 Rapid Quantitative Test(Chemiluminescence Immunoassay)	BT0501502	EUDAMED	IVD General	Active
SARS-CoV-2 Nucleic Acid eRDA Rapid Qualitative Test Kit（Colloidal gold）	BT0300501	EUDAMED	IVD General	Active
TT3 Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0501903	EUDAMED	IVD General	Active
NT-proBNP Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0507002	EUDAMED	IVD General	Active
RF Rapid Quantitative Test	BT0201001	EUDAMED	IVD General	Active
hs-CRP Rapid Quantitative Test(Chemiluminescence Immunoassay)	BT0501201	EUDAMED	IVD General	Active
Boiron	B6061403	EUDAMED	IVD General	Active
PG II Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0505402	EUDAMED	IVD General	Active
Uric Acid Test Strip （Electrochemical Method）	BT06007	EUDAMED	IVD General	Active
FluA/B&ADV&RSV Antigen Combo Rapid Test	BT0105401	EUDAMED	IVD General	Active
AMH Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0519001	EUDAMED	IVD General	Active
LH Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0503102	EUDAMED	IVD General	Active
β-HCG Rapid Quantitative Test (Fluorescence Immunoassay)	HR0200701	EUDAMED	IVD General	Active
Insulin Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0527003	EUDAMED	IVD General	Active
Vitamin B12 Rapid Quantitative Test	BT0200701	EUDAMED	IVD General	Active
AMH Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0519002	EUDAMED	IVD General	Active
25-OH Vitamin D Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0529002	EUDAMED	IVD General	Active
FSH Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0522002	EUDAMED	IVD General	Active
PG I Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0505303	EUDAMED	IVD General	Active
Biotime	/	EUDAMED	IVD General	Active
CRP Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0510003	EUDAMED	IVD General	Active
CRP Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0510002	EUDAMED	IVD General	Active
AMH Rapid Quantitative Test(Chemiluminescence Immunoassay)	BT0503701	EUDAMED	IVD General	Active
CA125 Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0505904	EUDAMED	IVD General	Active
CCP Rapid Quantitative Test	BT0201101	EUDAMED	IVD General	Active
Barbiturate （BAR） Rapid Test（Urine）	BT0105001	EUDAMED	IVD General	Active
PCR-CE α-Thalassemia Kit	04110019	EUDAMED	IVD General	Active
FT4 Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0502004	EUDAMED	IVD General	Active
Treponema pallidum Antibody Rapid Qualitative Test	BT0102701	EUDAMED	IVD General	Active
TT4 Rapid Quantitative Test (Fluorescence Immunoassay)	HR0201201	EUDAMED	IVD General	Active
TSH Rapid Quantitative Test(Chemiluminescence Immunoassay)	BT0501703	EUDAMED	IVD General	Active
FIA Analyzer BIOT-YG-I	BT0104	EUDAMED	Class A	Active
hs-cTnT Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0500505	EUDAMED	IVD General	Active
MPV Rapid Quantitative Test (eRDA)	BT0300402	EUDAMED	IVD General	Active
TRF Rapid Quantitative Test	BT2222	EUDAMED	IVD General	Active
Buprenorphine （BUP ）Rapid Test（Urine）	BT0104801	EUDAMED	IVD General	Active
NT-proBNP Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0507003	EUDAMED	IVD General	Active
NT-proBNP Rapid Quantitative Test	BT2106	EUDAMED	IVD General	Active
TT3 Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0501905	EUDAMED	IVD General	Active
C-peptide Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0528003	EUDAMED	IVD General	Active
HbA1c Rapid Quantitative Test (Fluorescence Immunoassay)	HR0200301	EUDAMED	IVD General	Active
HbAlc Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0507501	EUDAMED	IVD General	Active
CA125 Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0505901	EUDAMED	IVD General	Active
BNP Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0500701	EUDAMED	IVD General	Active
BNP Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0506001	EUDAMED	IVD General	Active
25-OH Vitamin D Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0529003	EUDAMED	IVD General	Active
BNP Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0500705	EUDAMED	IVD General	Active
Ferritin Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0503001	EUDAMED	IVD General	Active
TESTO Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0525002	EUDAMED	IVD General	Active
Dengue IgG/IgM Rapid Test	BT0101701	EUDAMED	IVD General	Active

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