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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 (509)

Page 4 of 11

Device	Model / Reference	Registries	Class	Status
FT4 Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0516002	EUDAMED	IVD General	Active
PCR-CE α/β-Thalassemia Kit	04110023	EUDAMED	IVD General	Active
SAA Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0501301	EUDAMED	IVD General	Active
AFP Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0504002	EUDAMED	IVD General	Active
C-peptide Rapid Quantitative Test(Chemiluminescence Immunoassay)	BT0504102	EUDAMED	IVD General	Active
cTnI/CK-MB/Myo/D-Dimer/NT-proBNP Rapid Quantitative Test	BT2107	EUDAMED	IVD General	Active
hs-cTnI Rapid Quantitative Test(Chemiluminescence Immunoassay)	BT0500602	EUDAMED	IVD General	Active
IL-6 Rapid Quantitative Test(Chemiluminescence Immunoassay)	BT0501505	EUDAMED	IVD General	Active
CA125 Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0505902	EUDAMED	IVD General	Active
SARS-CoV-2 Nucleic Acid eRDA Rapid Qualitative Test Kit（Colloidal gold）	BT0300502	EUDAMED	IVD General	Active
ST2 Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0501002	EUDAMED	IVD General	Active
BKM-02 Blood Ketone Monitoring System	BT0000801	EUDAMED	Class A	Active
Lp-PLA2 Rapid Quantitative Test(Chemiluminescence Immunoassay)	BT0500804	EUDAMED	IVD General	Active
TSH Rapid Quantitative Test(Chemiluminescence Immunoassay)	BT0501702	EUDAMED	IVD General	Active
Biotime	BT0500105	EUDAMED	IVD General	Active
TG Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0502201	EUDAMED	IVD General	Active
TGAb Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0502303	EUDAMED	IVD General	Active
NSE Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0504405	EUDAMED	IVD General	Active
G17 Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0505204	EUDAMED	IVD General	Active
Phencyclidine （PCP） Rapid Test（Urine）	BT0105301	EUDAMED	IVD General	Active
Biotime	BT0500305	EUDAMED	IVD General	Active
AMH Rapid Quantitative Test	BT2213	EUDAMED	IVD General	Active
SAA Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0501305	EUDAMED	IVD General	Active
PCR-CE DMD gene Kit	04110006	EUDAMED	IVD General	Active
TESTO Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0503401	EUDAMED	IVD General	Active
hs-cTnI Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0518003	EUDAMED	IVD General	Active
NSE Rapid Quantitative Test	BT0200401	EUDAMED	IVD General	Active
IL-6 Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0520002	EUDAMED	IVD General	Active
HbA1c Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0530003	EUDAMED	IVD General	Active
PRL Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0503205	EUDAMED	IVD General	Active
SARS-CoV-2 Antigen Rapid Qualitative Test (Oral Fluid)	BT0200303	EUDAMED	IVD General	Active
Strep A Antigen Rapid Test	BT0105501	EUDAMED	IVD General	Active
CA50 Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0505805	EUDAMED	IVD General	Active
BNP Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0506002	EUDAMED	IVD General	Active
SAA Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0501302	EUDAMED	IVD General	Active
G17 Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0505201	EUDAMED	IVD General	Active
TSH Rapid Quantitative Test (Fluorescence Immunoassay)	HR0203001	EUDAMED	IVD General	Active
TPOAb Rapid Quantitative Test(Chemiluminescence Immunoassay)	BT0502402	EUDAMED	IVD General	Active
Biotime	BT0500101	EUDAMED	IVD General	Active
IL-6 Rapid Quantitative Test(Chemiluminescence Immunoassay)	BT0501503	EUDAMED	IVD General	Active
Dengue Ag &Ab Combo Rapid Test	BT0101801	EUDAMED	IVD General	Active
PRL Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0524002	EUDAMED	IVD General	Active
FIA Analyzer FLI-100	BT0106	EUDAMED	Class A	Active
hs-cTnI Rapid Quantitative Test (Fluorescence Immunoassay)	HR0201401	EUDAMED	IVD General	Active
CA72-4 Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0506204	EUDAMED	IVD General	Active
LH Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0503101	EUDAMED	IVD General	Active
Insulin Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0527001	EUDAMED	IVD General	Active
TSH/FT3/FT4 Rapid Quantitative Test (Fluorescence Immunoassay)	HR0200201	EUDAMED	IVD General	Active
Myo Rapid Quantitative Test	BT2102	EUDAMED	IVD General	Active
Myo Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0500405	EUDAMED	IVD General	Active

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Importers

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Notified Bodies

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Authorities

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